Expert Commentary

Cesarean birth is one of the most common major surgical procedures performed in developed countries¹ with over 1,170,000 cesarean births in the United States in 2021.² Many surgeons and anesthesiologists believe that Enhanced Recovery after Surgery (ERAS) pathways improve surgical outcomes.^3,4 Important goals of ERAS include setting patient expectations for the surgical procedure, accelerating patient recovery to full function, and minimizing perioperative complications such as severe nausea, aspiration, surgical site infection, wound complications, and perioperative anemia. The ERAS Society in 2018^5-7 and the Society for Obstetric Anesthesia and Perinatology (SOAP) in 2021⁸ proposed ERAS pathways for cesarean birth. Both societies recommended that obstetric units consider adopting an ERAS pathway compatible with local clinical resources. In addition, the American College of Obstetricians and Gynecologists (ACOG) has provided guidance for implementing ERAS pathways for gynecologic surgery.⁹ The consistent use of standardized protocols to improve surgical care in obstetrics should lead to a reduction in care variation and improve health equity outcomes.

The clinical interventions recommended for ERAS cesarean birth occur sequentially in the preoperative, intraoperative, and postoperative phases of care. The recommendations associated with each of these phases are reviewed below. It is important to note that each obstetric unit should use a multidisciplinary process to develop an ERAS pathway that best supports local practice given clinician preferences, patient characteristics, and resource availability.
 

Preoperative components of ERAS

Standardized patient education (SPE). SPE is an important component of ERAS, although evidence to support the recommendation is limited. At a minimum a written handout describing steps in the cesarean birth process, or a patient-education video should be part of patient education. The University of Michigan Medical Center has produced a 3-minute video for patients explaining ERAS cesarean birth.¹⁰ The University of Maryland Medical Center has produced a 2.5-minute video in English and Spanish, explaining ERAS cesarean birth for patients.¹¹ Some surgeons place a telephone call to patients the evening before surgery to help orient the patient to ERAS cesarean birth.

Breastfeeding education. An important goal of obstetric care is to optimize the rate of exclusive breastfeeding at birth. Breastfeeding education, including a commitment to support the initiation of breastfeeding within 1 hour of birth, may enhance the rate of exclusive breastfeeding. There are numerous videos available for patients about breastfeeding after cesarean birth (as an example, see: https://www.youtube.com/watch?v=9iOGn85NdTg).

Limit fasting. In the past, surgical guidelines recommended fasting after midnight prior to surgery. The ERAS Society recommends that patients should be encouraged to drink clear fluids up to 2 hours before surgery and may have a light meal up to 6 hours before surgery (Part 1).

Carbohydrate loading. Surgery causes a metabolic stress that is increased by fasting. Carbohydrate loading prior to surgery reduces the magnitude of the catabolic state caused by the combination of surgery and fasting.¹² SOAP and the ERAS Society recommend oral carbohydrate fluid supplementation 2 hours before surgery for nondiabetic patients. SOAP suggests 32 oz of Gatorade or 16 oz of clear apple juice as options for carbohydrate loading. For diabetic patients, the carbohydrate load can be omitted. In fasting pregnant patients at term, gastric emptying was near complete 2 hours after consumption of 400 mL of a carbohydrate drink.¹³ In one study, consumption of 400 mL of a carbohydrate drink 2 hours before cesarean resulted in a 7% increase in the newborn blood glucose level at 20 min after delivery.¹⁴

Minimize preoperative anemia. Approximately 50% of pregnant women are iron deficient and approximately 10% are anemic in the third trimester.^15,16 Cesarean birth is associated with significant blood loss necessitating the need to optimize red blood cell mass before surgery. Measuring ferritin to identify patients with iron deficiency and aggressive iron replacement, including intravenous iron if necessary, will reduce the prevalence of anemia prior to cesarean birth.¹⁷ Another cause of anemia in pregnancy is vitamin B12 (cobalamin) deficiency. Low vitamin B12 is especially common in pregnant patients who have previously had bariatric surgery. One study reported that, of 113 pregnant patients who were, on average, 3 years from a bariatric surgery procedure, 12% had vitamin B12 circulating levels < 130 pg/mL.¹⁸ Among pregnant patients who are anemic, and do not have a hemoglobinopathy, measuring ferritin, folic acid, and vitamin B12 will help identify the cause of anemia and guide treatment.¹⁹

Optimize preoperative physical condition. Improving healthy behaviors and reducing unhealthy behaviors preoperatively may enhance patient recovery to full function. In the weeks before scheduled cesarean birth, cessation of the use of tobacco products, optimizing activity and improving diet quality, including increasing protein intake, may best prepare patients for the metabolic stress of surgery.

Continue to: Intraoperative components of ERAS...

Intraoperative components of ERAS

Reduce the risk of surgical site infection (SSI) and wound complications. Bundles that include antibiotics, chlorhexidine (or an alternative antibacterial soap) and clippers have been shown to reduce SSI.²⁰ Routine administration of preoperative antibiotics is a consensus recommendation and there is high adherence with this recommendation in the United States. Chlorhexidine-alcohol is the preferred solution for skin preparation. Vaginal preparation with povidine-iodine or chlorhexidine may be considered.⁶

Surgical technique. Blunt extension of a transverse hysterotomy may reduce blood loss. Closure of the hysterotomy incision in 2 layers is recommended to reduce uterine scar dehiscence in a subsequent pregnancy. If the patient has ≥2 cm of subcutaneous tissue, this layer should be approximated with sutures. Skin closure should be with subcuticular suture.⁶

Optimize uterotonic administration. Routine use of uterotonics reduces the risk of blood loss, transfusion, and postoperative anemia. There is high adherence with the use of uterotonic administration after birth in the United States.^6,8

Ensure normothermia. Many patients become hypothermic during a cesarean birth. Active warming of the patient with an in-line IV fluid warmer and forced air warming over the patient’s body can reduce the risk of hypothermia.⁸

Initiate multimodal anesthesia. Anesthesiologists often use intrathecal or epidural morphine to enhance analgesia. Ketorolac administration prior to completion of the cesarean procedure and perioperative administration of acetaminophen may reduce postoperative pain.⁸ The use of preoperative antiemetics will reduce intraoperative and postoperative nausea and vomiting.

Initiate VTE prophylaxis. Pneumatic compression stockings are recommended. Anticoagulation should not be routinely used for VTE prophylaxis.⁶

Postoperative components of ERAS

Patient education to prepare for discharge home when ready. Patient education focused on home when ready is important in preparing the patient for discharge home.⁷ Completion of required newborn testing, lactation education, and contraception planning plus coordination of newborn pediatric follow-up is necessary before discharge.

Support early return of bowel function. Early return of bowel function is best supported by a multimodal approach including initiation of clear fluid intake immediately following surgery, encouraging consumption of a regular diet within 2⁷ to 4 hours⁸ following surgery. Gum chewing for at least 5 minutes 3 times daily accelerates return of bowel function.⁸ In a meta-analysis of 10 randomized studies examining the effect of gum chewing after cesarean, the investigators reported that gum chewing shortened the time to passage of flatus and defecation.²¹

Early ambulation.

Sequentially advanced activity, starting with sitting on the edge of the bed, sitting in a chair, and ambulation within 8 hours of surgery, is recommended to facilitate faster recovery, reduce rates of complications, and enable transition to home.⁸

Early removal of the urinary catheter. It is recommended that the urinary catheter be removed within 12 hours after cesarean birth.⁸ Early removal of the urinary catheter increases patient mobility and reduces the length of hospitalization. Early removal of the urinary catheter may be associated with postoperative urinary retention and recatheterization in a small number of patients.

Prescribe routinely scheduled acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) and ketorolac. A key component of ERAS cesarean birth is the standardized administration of nonopioid pain medicines, alternating doses of acetaminophen and an NSAID. ERAS cesarean birth is likely to result in a reduction in inpatient and postdischarge opioid use.^22-24

VTE prophylaxis. Pneumatic compression stockings are recommended. Anticoagulation should not be routinely used for VTE prophylaxis.⁸

Auditing and reporting adherence with components of ERAS

In clinical practice there may be a gap between a clinician’s subjective perception of their performance and an independent audit of their clinical performance. ERAS pathways should be implemented with a commitment to performing audits and providing quantitative feedback to clinicians. Consistent use of measurement, feedback, and coaching can improve performance and reduce variation among individual clinicians. As an example, in one study of the use of a surgical safety checklist, 99% of the surgeons reported that they routinely used a surgical safety checklist, but the audit showed that the checklist was used in only 60% of cases.²⁵ Gaps between self-reported performance and audited performance are common in clinical practice. Audits with feedback are critical to improving adherence with the components of an ERAS pathway.

Three independent systematic reviews and meta-analyses report that ERAS pathways reduce hospital length of stay without increasing the readmission rate.^26-28 One meta-analysis reported that ERAS may also reduce time to first mobilization and result in earlier removal of the urinary catheter.²⁶ ERAS pathways also may reduce postoperative complications, lower pain scores, and decrease opioid use.²⁷ The general consensus among quality and safety experts is that reducing variation through standardization of pathways is generally associated with improved quality and enhanced safety. ERAS pathways have been widely accepted in multiple surgical fields. ERAS pathways should become the standard for performing cesarean procedures.●

Cesarean birth is one of the most common major surgical procedures performed in developed countries¹ with over 1,170,000 cesarean births in the United States in 2021.² Many surgeons and anesthesiologists believe that Enhanced Recovery after Surgery (ERAS) pathways improve surgical outcomes.^3,4 Important goals of ERAS include setting patient expectations for the surgical procedure, accelerating patient recovery to full function, and minimizing perioperative complications such as severe nausea, aspiration, surgical site infection, wound complications, and perioperative anemia. The ERAS Society in 2018^5-7 and the Society for Obstetric Anesthesia and Perinatology (SOAP) in 2021⁸ proposed ERAS pathways for cesarean birth. Both societies recommended that obstetric units consider adopting an ERAS pathway compatible with local clinical resources. In addition, the American College of Obstetricians and Gynecologists (ACOG) has provided guidance for implementing ERAS pathways for gynecologic surgery.⁹ The consistent use of standardized protocols to improve surgical care in obstetrics should lead to a reduction in care variation and improve health equity outcomes.

The clinical interventions recommended for ERAS cesarean birth occur sequentially in the preoperative, intraoperative, and postoperative phases of care. The recommendations associated with each of these phases are reviewed below. It is important to note that each obstetric unit should use a multidisciplinary process to develop an ERAS pathway that best supports local practice given clinician preferences, patient characteristics, and resource availability.
 

Preoperative components of ERAS

Standardized patient education (SPE). SPE is an important component of ERAS, although evidence to support the recommendation is limited. At a minimum a written handout describing steps in the cesarean birth process, or a patient-education video should be part of patient education. The University of Michigan Medical Center has produced a 3-minute video for patients explaining ERAS cesarean birth.¹⁰ The University of Maryland Medical Center has produced a 2.5-minute video in English and Spanish, explaining ERAS cesarean birth for patients.¹¹ Some surgeons place a telephone call to patients the evening before surgery to help orient the patient to ERAS cesarean birth.

Breastfeeding education. An important goal of obstetric care is to optimize the rate of exclusive breastfeeding at birth. Breastfeeding education, including a commitment to support the initiation of breastfeeding within 1 hour of birth, may enhance the rate of exclusive breastfeeding. There are numerous videos available for patients about breastfeeding after cesarean birth (as an example, see: https://www.youtube.com/watch?v=9iOGn85NdTg).

Limit fasting. In the past, surgical guidelines recommended fasting after midnight prior to surgery. The ERAS Society recommends that patients should be encouraged to drink clear fluids up to 2 hours before surgery and may have a light meal up to 6 hours before surgery (Part 1).

Carbohydrate loading. Surgery causes a metabolic stress that is increased by fasting. Carbohydrate loading prior to surgery reduces the magnitude of the catabolic state caused by the combination of surgery and fasting.¹² SOAP and the ERAS Society recommend oral carbohydrate fluid supplementation 2 hours before surgery for nondiabetic patients. SOAP suggests 32 oz of Gatorade or 16 oz of clear apple juice as options for carbohydrate loading. For diabetic patients, the carbohydrate load can be omitted. In fasting pregnant patients at term, gastric emptying was near complete 2 hours after consumption of 400 mL of a carbohydrate drink.¹³ In one study, consumption of 400 mL of a carbohydrate drink 2 hours before cesarean resulted in a 7% increase in the newborn blood glucose level at 20 min after delivery.¹⁴

Minimize preoperative anemia. Approximately 50% of pregnant women are iron deficient and approximately 10% are anemic in the third trimester.^15,16 Cesarean birth is associated with significant blood loss necessitating the need to optimize red blood cell mass before surgery. Measuring ferritin to identify patients with iron deficiency and aggressive iron replacement, including intravenous iron if necessary, will reduce the prevalence of anemia prior to cesarean birth.¹⁷ Another cause of anemia in pregnancy is vitamin B12 (cobalamin) deficiency. Low vitamin B12 is especially common in pregnant patients who have previously had bariatric surgery. One study reported that, of 113 pregnant patients who were, on average, 3 years from a bariatric surgery procedure, 12% had vitamin B12 circulating levels < 130 pg/mL.¹⁸ Among pregnant patients who are anemic, and do not have a hemoglobinopathy, measuring ferritin, folic acid, and vitamin B12 will help identify the cause of anemia and guide treatment.¹⁹

Optimize preoperative physical condition. Improving healthy behaviors and reducing unhealthy behaviors preoperatively may enhance patient recovery to full function. In the weeks before scheduled cesarean birth, cessation of the use of tobacco products, optimizing activity and improving diet quality, including increasing protein intake, may best prepare patients for the metabolic stress of surgery.

Continue to: Intraoperative components of ERAS...

Intraoperative components of ERAS

Reduce the risk of surgical site infection (SSI) and wound complications. Bundles that include antibiotics, chlorhexidine (or an alternative antibacterial soap) and clippers have been shown to reduce SSI.²⁰ Routine administration of preoperative antibiotics is a consensus recommendation and there is high adherence with this recommendation in the United States. Chlorhexidine-alcohol is the preferred solution for skin preparation. Vaginal preparation with povidine-iodine or chlorhexidine may be considered.⁶

Surgical technique. Blunt extension of a transverse hysterotomy may reduce blood loss. Closure of the hysterotomy incision in 2 layers is recommended to reduce uterine scar dehiscence in a subsequent pregnancy. If the patient has ≥2 cm of subcutaneous tissue, this layer should be approximated with sutures. Skin closure should be with subcuticular suture.⁶

Optimize uterotonic administration. Routine use of uterotonics reduces the risk of blood loss, transfusion, and postoperative anemia. There is high adherence with the use of uterotonic administration after birth in the United States.^6,8

Ensure normothermia. Many patients become hypothermic during a cesarean birth. Active warming of the patient with an in-line IV fluid warmer and forced air warming over the patient’s body can reduce the risk of hypothermia.⁸

Initiate multimodal anesthesia. Anesthesiologists often use intrathecal or epidural morphine to enhance analgesia. Ketorolac administration prior to completion of the cesarean procedure and perioperative administration of acetaminophen may reduce postoperative pain.⁸ The use of preoperative antiemetics will reduce intraoperative and postoperative nausea and vomiting.

Initiate VTE prophylaxis. Pneumatic compression stockings are recommended. Anticoagulation should not be routinely used for VTE prophylaxis.⁶

Postoperative components of ERAS

Patient education to prepare for discharge home when ready. Patient education focused on home when ready is important in preparing the patient for discharge home.⁷ Completion of required newborn testing, lactation education, and contraception planning plus coordination of newborn pediatric follow-up is necessary before discharge.

Support early return of bowel function. Early return of bowel function is best supported by a multimodal approach including initiation of clear fluid intake immediately following surgery, encouraging consumption of a regular diet within 2⁷ to 4 hours⁸ following surgery. Gum chewing for at least 5 minutes 3 times daily accelerates return of bowel function.⁸ In a meta-analysis of 10 randomized studies examining the effect of gum chewing after cesarean, the investigators reported that gum chewing shortened the time to passage of flatus and defecation.²¹

Early ambulation.

Sequentially advanced activity, starting with sitting on the edge of the bed, sitting in a chair, and ambulation within 8 hours of surgery, is recommended to facilitate faster recovery, reduce rates of complications, and enable transition to home.⁸

Early removal of the urinary catheter. It is recommended that the urinary catheter be removed within 12 hours after cesarean birth.⁸ Early removal of the urinary catheter increases patient mobility and reduces the length of hospitalization. Early removal of the urinary catheter may be associated with postoperative urinary retention and recatheterization in a small number of patients.

Prescribe routinely scheduled acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) and ketorolac. A key component of ERAS cesarean birth is the standardized administration of nonopioid pain medicines, alternating doses of acetaminophen and an NSAID. ERAS cesarean birth is likely to result in a reduction in inpatient and postdischarge opioid use.^22-24

VTE prophylaxis. Pneumatic compression stockings are recommended. Anticoagulation should not be routinely used for VTE prophylaxis.⁸

Auditing and reporting adherence with components of ERAS

In clinical practice there may be a gap between a clinician’s subjective perception of their performance and an independent audit of their clinical performance. ERAS pathways should be implemented with a commitment to performing audits and providing quantitative feedback to clinicians. Consistent use of measurement, feedback, and coaching can improve performance and reduce variation among individual clinicians. As an example, in one study of the use of a surgical safety checklist, 99% of the surgeons reported that they routinely used a surgical safety checklist, but the audit showed that the checklist was used in only 60% of cases.²⁵ Gaps between self-reported performance and audited performance are common in clinical practice. Audits with feedback are critical to improving adherence with the components of an ERAS pathway.

Three independent systematic reviews and meta-analyses report that ERAS pathways reduce hospital length of stay without increasing the readmission rate.^26-28 One meta-analysis reported that ERAS may also reduce time to first mobilization and result in earlier removal of the urinary catheter.²⁶ ERAS pathways also may reduce postoperative complications, lower pain scores, and decrease opioid use.²⁷ The general consensus among quality and safety experts is that reducing variation through standardization of pathways is generally associated with improved quality and enhanced safety. ERAS pathways have been widely accepted in multiple surgical fields. ERAS pathways should become the standard for performing cesarean procedures.●

Cesarean birth is one of the most common major surgical procedures performed in developed countries¹ with over 1,170,000 cesarean births in the United States in 2021.² Many surgeons and anesthesiologists believe that Enhanced Recovery after Surgery (ERAS) pathways improve surgical outcomes.^3,4 Important goals of ERAS include setting patient expectations for the surgical procedure, accelerating patient recovery to full function, and minimizing perioperative complications such as severe nausea, aspiration, surgical site infection, wound complications, and perioperative anemia. The ERAS Society in 2018^5-7 and the Society for Obstetric Anesthesia and Perinatology (SOAP) in 2021⁸ proposed ERAS pathways for cesarean birth. Both societies recommended that obstetric units consider adopting an ERAS pathway compatible with local clinical resources. In addition, the American College of Obstetricians and Gynecologists (ACOG) has provided guidance for implementing ERAS pathways for gynecologic surgery.⁹ The consistent use of standardized protocols to improve surgical care in obstetrics should lead to a reduction in care variation and improve health equity outcomes.

The clinical interventions recommended for ERAS cesarean birth occur sequentially in the preoperative, intraoperative, and postoperative phases of care. The recommendations associated with each of these phases are reviewed below. It is important to note that each obstetric unit should use a multidisciplinary process to develop an ERAS pathway that best supports local practice given clinician preferences, patient characteristics, and resource availability.
 

Preoperative components of ERAS

Standardized patient education (SPE). SPE is an important component of ERAS, although evidence to support the recommendation is limited. At a minimum a written handout describing steps in the cesarean birth process, or a patient-education video should be part of patient education. The University of Michigan Medical Center has produced a 3-minute video for patients explaining ERAS cesarean birth.¹⁰ The University of Maryland Medical Center has produced a 2.5-minute video in English and Spanish, explaining ERAS cesarean birth for patients.¹¹ Some surgeons place a telephone call to patients the evening before surgery to help orient the patient to ERAS cesarean birth.

Breastfeeding education. An important goal of obstetric care is to optimize the rate of exclusive breastfeeding at birth. Breastfeeding education, including a commitment to support the initiation of breastfeeding within 1 hour of birth, may enhance the rate of exclusive breastfeeding. There are numerous videos available for patients about breastfeeding after cesarean birth (as an example, see: https://www.youtube.com/watch?v=9iOGn85NdTg).

Limit fasting. In the past, surgical guidelines recommended fasting after midnight prior to surgery. The ERAS Society recommends that patients should be encouraged to drink clear fluids up to 2 hours before surgery and may have a light meal up to 6 hours before surgery (Part 1).

Carbohydrate loading. Surgery causes a metabolic stress that is increased by fasting. Carbohydrate loading prior to surgery reduces the magnitude of the catabolic state caused by the combination of surgery and fasting.¹² SOAP and the ERAS Society recommend oral carbohydrate fluid supplementation 2 hours before surgery for nondiabetic patients. SOAP suggests 32 oz of Gatorade or 16 oz of clear apple juice as options for carbohydrate loading. For diabetic patients, the carbohydrate load can be omitted. In fasting pregnant patients at term, gastric emptying was near complete 2 hours after consumption of 400 mL of a carbohydrate drink.¹³ In one study, consumption of 400 mL of a carbohydrate drink 2 hours before cesarean resulted in a 7% increase in the newborn blood glucose level at 20 min after delivery.¹⁴

Minimize preoperative anemia. Approximately 50% of pregnant women are iron deficient and approximately 10% are anemic in the third trimester.^15,16 Cesarean birth is associated with significant blood loss necessitating the need to optimize red blood cell mass before surgery. Measuring ferritin to identify patients with iron deficiency and aggressive iron replacement, including intravenous iron if necessary, will reduce the prevalence of anemia prior to cesarean birth.¹⁷ Another cause of anemia in pregnancy is vitamin B12 (cobalamin) deficiency. Low vitamin B12 is especially common in pregnant patients who have previously had bariatric surgery. One study reported that, of 113 pregnant patients who were, on average, 3 years from a bariatric surgery procedure, 12% had vitamin B12 circulating levels < 130 pg/mL.¹⁸ Among pregnant patients who are anemic, and do not have a hemoglobinopathy, measuring ferritin, folic acid, and vitamin B12 will help identify the cause of anemia and guide treatment.¹⁹

Optimize preoperative physical condition. Improving healthy behaviors and reducing unhealthy behaviors preoperatively may enhance patient recovery to full function. In the weeks before scheduled cesarean birth, cessation of the use of tobacco products, optimizing activity and improving diet quality, including increasing protein intake, may best prepare patients for the metabolic stress of surgery.

Continue to: Intraoperative components of ERAS...

Intraoperative components of ERAS

Reduce the risk of surgical site infection (SSI) and wound complications. Bundles that include antibiotics, chlorhexidine (or an alternative antibacterial soap) and clippers have been shown to reduce SSI.²⁰ Routine administration of preoperative antibiotics is a consensus recommendation and there is high adherence with this recommendation in the United States. Chlorhexidine-alcohol is the preferred solution for skin preparation. Vaginal preparation with povidine-iodine or chlorhexidine may be considered.⁶

Surgical technique. Blunt extension of a transverse hysterotomy may reduce blood loss. Closure of the hysterotomy incision in 2 layers is recommended to reduce uterine scar dehiscence in a subsequent pregnancy. If the patient has ≥2 cm of subcutaneous tissue, this layer should be approximated with sutures. Skin closure should be with subcuticular suture.⁶

Optimize uterotonic administration. Routine use of uterotonics reduces the risk of blood loss, transfusion, and postoperative anemia. There is high adherence with the use of uterotonic administration after birth in the United States.^6,8

Ensure normothermia. Many patients become hypothermic during a cesarean birth. Active warming of the patient with an in-line IV fluid warmer and forced air warming over the patient’s body can reduce the risk of hypothermia.⁸

Initiate multimodal anesthesia. Anesthesiologists often use intrathecal or epidural morphine to enhance analgesia. Ketorolac administration prior to completion of the cesarean procedure and perioperative administration of acetaminophen may reduce postoperative pain.⁸ The use of preoperative antiemetics will reduce intraoperative and postoperative nausea and vomiting.

Initiate VTE prophylaxis. Pneumatic compression stockings are recommended. Anticoagulation should not be routinely used for VTE prophylaxis.⁶

Postoperative components of ERAS

Patient education to prepare for discharge home when ready. Patient education focused on home when ready is important in preparing the patient for discharge home.⁷ Completion of required newborn testing, lactation education, and contraception planning plus coordination of newborn pediatric follow-up is necessary before discharge.

Support early return of bowel function. Early return of bowel function is best supported by a multimodal approach including initiation of clear fluid intake immediately following surgery, encouraging consumption of a regular diet within 2⁷ to 4 hours⁸ following surgery. Gum chewing for at least 5 minutes 3 times daily accelerates return of bowel function.⁸ In a meta-analysis of 10 randomized studies examining the effect of gum chewing after cesarean, the investigators reported that gum chewing shortened the time to passage of flatus and defecation.²¹

Early ambulation.

Sequentially advanced activity, starting with sitting on the edge of the bed, sitting in a chair, and ambulation within 8 hours of surgery, is recommended to facilitate faster recovery, reduce rates of complications, and enable transition to home.⁸

Early removal of the urinary catheter. It is recommended that the urinary catheter be removed within 12 hours after cesarean birth.⁸ Early removal of the urinary catheter increases patient mobility and reduces the length of hospitalization. Early removal of the urinary catheter may be associated with postoperative urinary retention and recatheterization in a small number of patients.

Prescribe routinely scheduled acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) and ketorolac. A key component of ERAS cesarean birth is the standardized administration of nonopioid pain medicines, alternating doses of acetaminophen and an NSAID. ERAS cesarean birth is likely to result in a reduction in inpatient and postdischarge opioid use.^22-24

VTE prophylaxis. Pneumatic compression stockings are recommended. Anticoagulation should not be routinely used for VTE prophylaxis.⁸

Auditing and reporting adherence with components of ERAS

In clinical practice there may be a gap between a clinician’s subjective perception of their performance and an independent audit of their clinical performance. ERAS pathways should be implemented with a commitment to performing audits and providing quantitative feedback to clinicians. Consistent use of measurement, feedback, and coaching can improve performance and reduce variation among individual clinicians. As an example, in one study of the use of a surgical safety checklist, 99% of the surgeons reported that they routinely used a surgical safety checklist, but the audit showed that the checklist was used in only 60% of cases.²⁵ Gaps between self-reported performance and audited performance are common in clinical practice. Audits with feedback are critical to improving adherence with the components of an ERAS pathway.

Three independent systematic reviews and meta-analyses report that ERAS pathways reduce hospital length of stay without increasing the readmission rate.^26-28 One meta-analysis reported that ERAS may also reduce time to first mobilization and result in earlier removal of the urinary catheter.²⁶ ERAS pathways also may reduce postoperative complications, lower pain scores, and decrease opioid use.²⁷ The general consensus among quality and safety experts is that reducing variation through standardization of pathways is generally associated with improved quality and enhanced safety. ERAS pathways have been widely accepted in multiple surgical fields. ERAS pathways should become the standard for performing cesarean procedures.●

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

OBG Management Board Member Linda Bradley, MD, recently attended the Global Congress on Hysteroscopy in Malaga, Spain, May 26-27, 2022, organized by the Global Community on Hysteroscopy, and co-authored the article, “Implementation of office hysteroscopy for the evaluation and treatment of intrauterine pathology” in Obstetrics and Gynecology.¹ She is the Director of the Center for Menstrual Disorders, Fibroids and Hysteroscopic Services at Cleveland Clinic in Cleveland, Ohio. OBG Management recently caught up with her to ask about her perspectives on the expanded use of hysteroscopy in obstetrics and gynecology, and her call to “end blind endometrial sampling.”

OBG Management: What are the drawbacks of dilation and curettage?

Linda Bradley, MD: The standard in ObGyn for many years has been our reliance on the blind dilation and curettage (D&C)—it has been the mainstay for evaluation of the endometrial cavity. We know that it has risks, but most importantly, the procedure has low sensitivity for detecting focal pathology. This basic lack of confirmation of lesions makes a diagnosis impossible and patients are challenged in getting adequate treatment, and will not, since they may not know what options they have for the treatment of intrauterine pathology. 

Because it is a “blind procedure,” done without looking, we don’t know the endpoints, such as when is the procedure completed, how do we know we removed all of the lesions? Let’s look at our colleagues, like GI and colorectal physicians. If a patient presents with rectal bleeding, we would perform an exam, followed by either a colonoscopy or sigmoidoscopy. If a patient were vomiting up blood, a gastroenterologist would perform an upper endoscopy, look with a tube to see if there is an ulcer or something else as a source of the bleeding. If a patient were bleeding from the bladder, a urologist would use  a cystoscope for direct inspection. 

Unfortunately for gynecologists, only about 15% to 25% of us will use hysteroscopy as a diagnostic method²—a method that has excellent sensitivity in detecting endocervical disease, intrauterine disease, and proximal tubal pathology. Compared with blind curettage, we can visualize the cavity; we can sample the cavity directly; we can determine what the patient has and determine the proper surgical procedure, medical therapy, or reassurance that a patient may be offered. We often are looking at focal lesions, lesions in the uterine cavity that could be cancer, so we can make a diagnosis. Or we may be looking at small things, like endometrial hyperplasia, endocervical or endometrial polyps, retained products of conception, or fibroids. We can look at uterine pathology as well as anatomic issues and malformations—such as bicornuate or septate uterus. 

I actually say, “My hysteroscope is my stethoscope” because it allows us to evaluate for many things. The beauty of the new office hysteroscopes is that they are miniaturized. Doctors now have the ability to use reusable devices that are as small as 3 millimeters. There are disposable ones that are up to  3.5 to 4 millimeters in size. Gynecologists have the options to choose from reusuable rigid or flexible hysteroscopes or completely disposable devices. So, truly, we now should not have an excuse for evaluating a woman’s anatomy, especially for bleeding. We should no longer rely, as we have for the last century or more, just on blind sampling, because we miss focal lesions. 

OBG Management: When was the hysteroscope first introduced into the field?

Dr. Bradley: The technology employed in hysteroscopy has been around really since the last 150+ years, introduced by Dr. Pantaleoni. We just have not embraced its usefulness in our clinical practice for many years. Today, about 15% to 25% of gynecologists practicing in the United States are performing hysteroscopy in the office.¹

OBG Management: How does using hysteroscopy contribute to better patient outcomes?

Dr. Bradley: We can get a more accurate diagnosis—fewer false-negatives and a high degree of sensitivity in detecting focal lesions. With D&C, much focal pathology can be left behind. In a 2001 study, 105 symptomatic postmenopausal women with bleeding and thickened lining of the uterus greater than  5 mm on ultrasound underwent blind D&C. They found that 80% of the women had intracavitary lesions and 90% had focal lesions. In fact, 87% of the patients with focal lesions still had residual pathology after the blind D&C.³ The D&C procedure missed 58% of polyps, 50% of endometrial hyperplasia, 60% of cases of complex atypical hyperplasia, and even 11% of endometrial cancers. So these numbers are just not very good. Direct inspection of the uterus, with uninterrupted visualization through hysteroscopy, with removal of lesions under direct visualization, should be our goal. 

Blind sampling also poses greater risk for things like perforation. In addition, you not only can miss lesions by just scraping the endometrium, D&C also can leave lesions just floating around in the uterine cavity, with those lesions never retrieved. With office hysteroscopy, the physician can be more successful in treating a condition because once you see what is going on in the uterine cavity, you can say, “Okay, I can fix this with a surgical procedure. What instruments do I need? How much time is it going to take? Is this a straightforward case? Is it more complicated? Do I let an intern do the case? Is this for a more senior resident or fellow?” So I think it helps to direct the next steps for surgical management and even medical management, which also could be what we call “one-stop shopping.” For instance, for directed biopsies for removal of small polyps, for patients that can tolerate the procedure a little longer, the diagnostic hysteroscopy then becomes a management, an operative procedure, that really, for myself, can be done in the office. Removal of larger fibroids, because of fluid management and other concerns, would not be done in the office. Most patients tolerate office procedures, but it also depends on a patient’s weight, and her ability to relax during the procedure. 

The ultimate goal for hysteroscopy is a minimum of diagnosis, meaning in less than 2, 3 minutes, you can look inside the uterus. Our devices are 3 millimeters in size; I tell my patients, it’s the size of “a piece of spaghetti or pasta,” and we will just take a look. If we see a polyp, okay, if your office is not equipped, because then you need a different type of equipment for removal, then take her to the operating room. The patient would be under brief anesthesia and go home an hour or 2 later. So really, for physicians, we just need to embrace the technology to make a diagnosis, just look, and then from there decide what is next.

OBG Management: What techniques do you use to minimize or eliminate patient discomfort during hysteroscopy?...

OBG Management: What techniques do you use to minimize or eliminate patient discomfort during hysteroscopy?

Dr. Bradley: I think first is always be patient-centric. Let patients be prepared for the procedure. We have reading materials; our nurses explain the procedure. In the office, I try to prepare the patient for success. I let her know what is going on. A friend, family member can be with her. We have a nurse that understands the procedure; she explains it well. We have a type of bed that allows the patients’ legs to rest more comfortably in the stirrups—a leg rest kind of stirrup. We use a heating pad. Some patients like to hear music. Some patients like to have aromatherapy. We are quick and efficient, and typically just talk to the patient throughout the procedure. Although some patients don’t like this explanatory, “talkative” approach—they say, “Dr. Bradley, just do the procedure. I don’t want to know you are touching the cervix. I don’t want to know that you’re prepping. Just do it.” 

But I like what we called it when I was growing up: vocal-local (talk to your patient and explain as you proceed). It’s like local anesthesia. For these procedures in the office you usually do not have to use numbing medicine or a paracervical block. Look at the patient’s age, number of years in menopause, whether or not  she has delivered vaginally, and what her cervix looks like. Does she have a sexually transmitted infection or pelvic inflammatory disease? Sometimes we will use misoprostol, my personal preference is oral, but there are data to suggest that vaginal can be of help.⁴ We suggest Motrin, Tylenol an hour or 2 before, and we always want patients to not come in on an empty stomach. There is also the option of primrose oil, a supplement, that patients buy at the drug store in the vitamin section. It’s used for cervical softening. It is taken orally.^5-7

If they want, patients can watch a video—similar to watching childbirth videos when I used to deliver babies. At some point we started putting mirrors where women could see their efforts of pushing a baby out, as it might give them more willpower to push harder. Some people don’t want to look. But the majority of women will do well in this setting. I do have a small number of women that just say, “I can’t do this in the office,” and so in those cases, they can go to the operating room. But the main idea is, even in an operating room, you are not just doing a D&C. You are still going to look inside with a hysteroscope and have a great panoramic view of what is going on, and remove a lesion with an instrument while you watch. Not a process of looking with the hysteroscope, scraping with a curettage, and thinking that you are complete. Targeted removal of focal lesions under continuous visualization is the goal.

OBG Management: Can you describe the goals of the consensus document on ending blind sampling co-created by the European Society of Gynecologic Endoscopy, AAGL, and the Global Community on Hysteroscopy? 

Dr. Bradley: Our goal for this year is to get a systematic review and guidelines paper written that speaks to what we have just talked about. We want to have as many articles about why blind sampling is not beneficial, with too many misses, and now we have new technology available. We want to speak to physicians to solve the conundrum of bleeding, with equivocal ultrasounds, equivocal saline infusion, sonograms, equivocal MRIs—be able to take a look. Let’s come up to speed like our other colleagues in other specialties that “look.” A systematic review guideline document will provide the evidence that blind  D&C is fraught with problems and how often we miss disease and its inherent risk.

We need to, by itself, for most of our patients, abandon D&C because we have too many missed diagnoses. As doctors we have to be lifelong learners. There was no robot back in the day. We were not able to do laparoscopic hysterectomies, there were no MRIs. I remember in our city, there was one CT scan. We just did not have a lot of technology. The half-life of medical knowledge used to be decades—you graduated in the ‘60s, you could be a great gynecologist for the next  30 years because there was not that much going on. When I finished in the mid to late ‘80s, there was no hysteroscopy training. But I have come to see its value, the science  behind it.

So what I say to doctors is, “We learn so many new things, we shouldn’t get stuck in just saying, ‘I didn’t do this when I was in training.’” And if your thought is, “Oh, in my practice, I don’t have that many cases,” you still need to be able to know who in your community can be a resource to your patients. As Maya Angelou says, “When you know better, you should do better.” And that’s where I am now—to be a lifelong learner, and just  do it.

Lastly, patient influence is very important. If patients ask, “How are you going to do the procedure?” it’s a driver for change. By utilizing hysteroscopy in the evaluation of the intrauterine cavity, we have the opportunity to change the face of evaluation and treatment for abnormal uterine bleeding.●

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

OBG Management Board Member Linda Bradley, MD, recently attended the Global Congress on Hysteroscopy in Malaga, Spain, May 26-27, 2022, organized by the Global Community on Hysteroscopy, and co-authored the article, “Implementation of office hysteroscopy for the evaluation and treatment of intrauterine pathology” in Obstetrics and Gynecology.¹ She is the Director of the Center for Menstrual Disorders, Fibroids and Hysteroscopic Services at Cleveland Clinic in Cleveland, Ohio. OBG Management recently caught up with her to ask about her perspectives on the expanded use of hysteroscopy in obstetrics and gynecology, and her call to “end blind endometrial sampling.”

OBG Management: What are the drawbacks of dilation and curettage?

Linda Bradley, MD: The standard in ObGyn for many years has been our reliance on the blind dilation and curettage (D&C)—it has been the mainstay for evaluation of the endometrial cavity. We know that it has risks, but most importantly, the procedure has low sensitivity for detecting focal pathology. This basic lack of confirmation of lesions makes a diagnosis impossible and patients are challenged in getting adequate treatment, and will not, since they may not know what options they have for the treatment of intrauterine pathology. 

Because it is a “blind procedure,” done without looking, we don’t know the endpoints, such as when is the procedure completed, how do we know we removed all of the lesions? Let’s look at our colleagues, like GI and colorectal physicians. If a patient presents with rectal bleeding, we would perform an exam, followed by either a colonoscopy or sigmoidoscopy. If a patient were vomiting up blood, a gastroenterologist would perform an upper endoscopy, look with a tube to see if there is an ulcer or something else as a source of the bleeding. If a patient were bleeding from the bladder, a urologist would use  a cystoscope for direct inspection. 

Unfortunately for gynecologists, only about 15% to 25% of us will use hysteroscopy as a diagnostic method²—a method that has excellent sensitivity in detecting endocervical disease, intrauterine disease, and proximal tubal pathology. Compared with blind curettage, we can visualize the cavity; we can sample the cavity directly; we can determine what the patient has and determine the proper surgical procedure, medical therapy, or reassurance that a patient may be offered. We often are looking at focal lesions, lesions in the uterine cavity that could be cancer, so we can make a diagnosis. Or we may be looking at small things, like endometrial hyperplasia, endocervical or endometrial polyps, retained products of conception, or fibroids. We can look at uterine pathology as well as anatomic issues and malformations—such as bicornuate or septate uterus. 

I actually say, “My hysteroscope is my stethoscope” because it allows us to evaluate for many things. The beauty of the new office hysteroscopes is that they are miniaturized. Doctors now have the ability to use reusable devices that are as small as 3 millimeters. There are disposable ones that are up to  3.5 to 4 millimeters in size. Gynecologists have the options to choose from reusuable rigid or flexible hysteroscopes or completely disposable devices. So, truly, we now should not have an excuse for evaluating a woman’s anatomy, especially for bleeding. We should no longer rely, as we have for the last century or more, just on blind sampling, because we miss focal lesions. 

OBG Management: When was the hysteroscope first introduced into the field?

Dr. Bradley: The technology employed in hysteroscopy has been around really since the last 150+ years, introduced by Dr. Pantaleoni. We just have not embraced its usefulness in our clinical practice for many years. Today, about 15% to 25% of gynecologists practicing in the United States are performing hysteroscopy in the office.¹

OBG Management: How does using hysteroscopy contribute to better patient outcomes?

Dr. Bradley: We can get a more accurate diagnosis—fewer false-negatives and a high degree of sensitivity in detecting focal lesions. With D&C, much focal pathology can be left behind. In a 2001 study, 105 symptomatic postmenopausal women with bleeding and thickened lining of the uterus greater than  5 mm on ultrasound underwent blind D&C. They found that 80% of the women had intracavitary lesions and 90% had focal lesions. In fact, 87% of the patients with focal lesions still had residual pathology after the blind D&C.³ The D&C procedure missed 58% of polyps, 50% of endometrial hyperplasia, 60% of cases of complex atypical hyperplasia, and even 11% of endometrial cancers. So these numbers are just not very good. Direct inspection of the uterus, with uninterrupted visualization through hysteroscopy, with removal of lesions under direct visualization, should be our goal. 

Blind sampling also poses greater risk for things like perforation. In addition, you not only can miss lesions by just scraping the endometrium, D&C also can leave lesions just floating around in the uterine cavity, with those lesions never retrieved. With office hysteroscopy, the physician can be more successful in treating a condition because once you see what is going on in the uterine cavity, you can say, “Okay, I can fix this with a surgical procedure. What instruments do I need? How much time is it going to take? Is this a straightforward case? Is it more complicated? Do I let an intern do the case? Is this for a more senior resident or fellow?” So I think it helps to direct the next steps for surgical management and even medical management, which also could be what we call “one-stop shopping.” For instance, for directed biopsies for removal of small polyps, for patients that can tolerate the procedure a little longer, the diagnostic hysteroscopy then becomes a management, an operative procedure, that really, for myself, can be done in the office. Removal of larger fibroids, because of fluid management and other concerns, would not be done in the office. Most patients tolerate office procedures, but it also depends on a patient’s weight, and her ability to relax during the procedure. 

The ultimate goal for hysteroscopy is a minimum of diagnosis, meaning in less than 2, 3 minutes, you can look inside the uterus. Our devices are 3 millimeters in size; I tell my patients, it’s the size of “a piece of spaghetti or pasta,” and we will just take a look. If we see a polyp, okay, if your office is not equipped, because then you need a different type of equipment for removal, then take her to the operating room. The patient would be under brief anesthesia and go home an hour or 2 later. So really, for physicians, we just need to embrace the technology to make a diagnosis, just look, and then from there decide what is next.

OBG Management: What techniques do you use to minimize or eliminate patient discomfort during hysteroscopy?...

OBG Management: What techniques do you use to minimize or eliminate patient discomfort during hysteroscopy?

Dr. Bradley: I think first is always be patient-centric. Let patients be prepared for the procedure. We have reading materials; our nurses explain the procedure. In the office, I try to prepare the patient for success. I let her know what is going on. A friend, family member can be with her. We have a nurse that understands the procedure; she explains it well. We have a type of bed that allows the patients’ legs to rest more comfortably in the stirrups—a leg rest kind of stirrup. We use a heating pad. Some patients like to hear music. Some patients like to have aromatherapy. We are quick and efficient, and typically just talk to the patient throughout the procedure. Although some patients don’t like this explanatory, “talkative” approach—they say, “Dr. Bradley, just do the procedure. I don’t want to know you are touching the cervix. I don’t want to know that you’re prepping. Just do it.” 

But I like what we called it when I was growing up: vocal-local (talk to your patient and explain as you proceed). It’s like local anesthesia. For these procedures in the office you usually do not have to use numbing medicine or a paracervical block. Look at the patient’s age, number of years in menopause, whether or not  she has delivered vaginally, and what her cervix looks like. Does she have a sexually transmitted infection or pelvic inflammatory disease? Sometimes we will use misoprostol, my personal preference is oral, but there are data to suggest that vaginal can be of help.⁴ We suggest Motrin, Tylenol an hour or 2 before, and we always want patients to not come in on an empty stomach. There is also the option of primrose oil, a supplement, that patients buy at the drug store in the vitamin section. It’s used for cervical softening. It is taken orally.^5-7

If they want, patients can watch a video—similar to watching childbirth videos when I used to deliver babies. At some point we started putting mirrors where women could see their efforts of pushing a baby out, as it might give them more willpower to push harder. Some people don’t want to look. But the majority of women will do well in this setting. I do have a small number of women that just say, “I can’t do this in the office,” and so in those cases, they can go to the operating room. But the main idea is, even in an operating room, you are not just doing a D&C. You are still going to look inside with a hysteroscope and have a great panoramic view of what is going on, and remove a lesion with an instrument while you watch. Not a process of looking with the hysteroscope, scraping with a curettage, and thinking that you are complete. Targeted removal of focal lesions under continuous visualization is the goal.

OBG Management: Can you describe the goals of the consensus document on ending blind sampling co-created by the European Society of Gynecologic Endoscopy, AAGL, and the Global Community on Hysteroscopy? 

Dr. Bradley: Our goal for this year is to get a systematic review and guidelines paper written that speaks to what we have just talked about. We want to have as many articles about why blind sampling is not beneficial, with too many misses, and now we have new technology available. We want to speak to physicians to solve the conundrum of bleeding, with equivocal ultrasounds, equivocal saline infusion, sonograms, equivocal MRIs—be able to take a look. Let’s come up to speed like our other colleagues in other specialties that “look.” A systematic review guideline document will provide the evidence that blind  D&C is fraught with problems and how often we miss disease and its inherent risk.

We need to, by itself, for most of our patients, abandon D&C because we have too many missed diagnoses. As doctors we have to be lifelong learners. There was no robot back in the day. We were not able to do laparoscopic hysterectomies, there were no MRIs. I remember in our city, there was one CT scan. We just did not have a lot of technology. The half-life of medical knowledge used to be decades—you graduated in the ‘60s, you could be a great gynecologist for the next  30 years because there was not that much going on. When I finished in the mid to late ‘80s, there was no hysteroscopy training. But I have come to see its value, the science  behind it.

So what I say to doctors is, “We learn so many new things, we shouldn’t get stuck in just saying, ‘I didn’t do this when I was in training.’” And if your thought is, “Oh, in my practice, I don’t have that many cases,” you still need to be able to know who in your community can be a resource to your patients. As Maya Angelou says, “When you know better, you should do better.” And that’s where I am now—to be a lifelong learner, and just  do it.

Lastly, patient influence is very important. If patients ask, “How are you going to do the procedure?” it’s a driver for change. By utilizing hysteroscopy in the evaluation of the intrauterine cavity, we have the opportunity to change the face of evaluation and treatment for abnormal uterine bleeding.●

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

OBG Management Board Member Linda Bradley, MD, recently attended the Global Congress on Hysteroscopy in Malaga, Spain, May 26-27, 2022, organized by the Global Community on Hysteroscopy, and co-authored the article, “Implementation of office hysteroscopy for the evaluation and treatment of intrauterine pathology” in Obstetrics and Gynecology.¹ She is the Director of the Center for Menstrual Disorders, Fibroids and Hysteroscopic Services at Cleveland Clinic in Cleveland, Ohio. OBG Management recently caught up with her to ask about her perspectives on the expanded use of hysteroscopy in obstetrics and gynecology, and her call to “end blind endometrial sampling.”

OBG Management: What are the drawbacks of dilation and curettage?

Linda Bradley, MD: The standard in ObGyn for many years has been our reliance on the blind dilation and curettage (D&C)—it has been the mainstay for evaluation of the endometrial cavity. We know that it has risks, but most importantly, the procedure has low sensitivity for detecting focal pathology. This basic lack of confirmation of lesions makes a diagnosis impossible and patients are challenged in getting adequate treatment, and will not, since they may not know what options they have for the treatment of intrauterine pathology. 

Because it is a “blind procedure,” done without looking, we don’t know the endpoints, such as when is the procedure completed, how do we know we removed all of the lesions? Let’s look at our colleagues, like GI and colorectal physicians. If a patient presents with rectal bleeding, we would perform an exam, followed by either a colonoscopy or sigmoidoscopy. If a patient were vomiting up blood, a gastroenterologist would perform an upper endoscopy, look with a tube to see if there is an ulcer or something else as a source of the bleeding. If a patient were bleeding from the bladder, a urologist would use  a cystoscope for direct inspection. 

Unfortunately for gynecologists, only about 15% to 25% of us will use hysteroscopy as a diagnostic method²—a method that has excellent sensitivity in detecting endocervical disease, intrauterine disease, and proximal tubal pathology. Compared with blind curettage, we can visualize the cavity; we can sample the cavity directly; we can determine what the patient has and determine the proper surgical procedure, medical therapy, or reassurance that a patient may be offered. We often are looking at focal lesions, lesions in the uterine cavity that could be cancer, so we can make a diagnosis. Or we may be looking at small things, like endometrial hyperplasia, endocervical or endometrial polyps, retained products of conception, or fibroids. We can look at uterine pathology as well as anatomic issues and malformations—such as bicornuate or septate uterus. 

I actually say, “My hysteroscope is my stethoscope” because it allows us to evaluate for many things. The beauty of the new office hysteroscopes is that they are miniaturized. Doctors now have the ability to use reusable devices that are as small as 3 millimeters. There are disposable ones that are up to  3.5 to 4 millimeters in size. Gynecologists have the options to choose from reusuable rigid or flexible hysteroscopes or completely disposable devices. So, truly, we now should not have an excuse for evaluating a woman’s anatomy, especially for bleeding. We should no longer rely, as we have for the last century or more, just on blind sampling, because we miss focal lesions. 

OBG Management: When was the hysteroscope first introduced into the field?

Dr. Bradley: The technology employed in hysteroscopy has been around really since the last 150+ years, introduced by Dr. Pantaleoni. We just have not embraced its usefulness in our clinical practice for many years. Today, about 15% to 25% of gynecologists practicing in the United States are performing hysteroscopy in the office.¹

OBG Management: How does using hysteroscopy contribute to better patient outcomes?

Dr. Bradley: We can get a more accurate diagnosis—fewer false-negatives and a high degree of sensitivity in detecting focal lesions. With D&C, much focal pathology can be left behind. In a 2001 study, 105 symptomatic postmenopausal women with bleeding and thickened lining of the uterus greater than  5 mm on ultrasound underwent blind D&C. They found that 80% of the women had intracavitary lesions and 90% had focal lesions. In fact, 87% of the patients with focal lesions still had residual pathology after the blind D&C.³ The D&C procedure missed 58% of polyps, 50% of endometrial hyperplasia, 60% of cases of complex atypical hyperplasia, and even 11% of endometrial cancers. So these numbers are just not very good. Direct inspection of the uterus, with uninterrupted visualization through hysteroscopy, with removal of lesions under direct visualization, should be our goal. 

Blind sampling also poses greater risk for things like perforation. In addition, you not only can miss lesions by just scraping the endometrium, D&C also can leave lesions just floating around in the uterine cavity, with those lesions never retrieved. With office hysteroscopy, the physician can be more successful in treating a condition because once you see what is going on in the uterine cavity, you can say, “Okay, I can fix this with a surgical procedure. What instruments do I need? How much time is it going to take? Is this a straightforward case? Is it more complicated? Do I let an intern do the case? Is this for a more senior resident or fellow?” So I think it helps to direct the next steps for surgical management and even medical management, which also could be what we call “one-stop shopping.” For instance, for directed biopsies for removal of small polyps, for patients that can tolerate the procedure a little longer, the diagnostic hysteroscopy then becomes a management, an operative procedure, that really, for myself, can be done in the office. Removal of larger fibroids, because of fluid management and other concerns, would not be done in the office. Most patients tolerate office procedures, but it also depends on a patient’s weight, and her ability to relax during the procedure. 

The ultimate goal for hysteroscopy is a minimum of diagnosis, meaning in less than 2, 3 minutes, you can look inside the uterus. Our devices are 3 millimeters in size; I tell my patients, it’s the size of “a piece of spaghetti or pasta,” and we will just take a look. If we see a polyp, okay, if your office is not equipped, because then you need a different type of equipment for removal, then take her to the operating room. The patient would be under brief anesthesia and go home an hour or 2 later. So really, for physicians, we just need to embrace the technology to make a diagnosis, just look, and then from there decide what is next.

OBG Management: What techniques do you use to minimize or eliminate patient discomfort during hysteroscopy?...

OBG Management: What techniques do you use to minimize or eliminate patient discomfort during hysteroscopy?

Dr. Bradley: I think first is always be patient-centric. Let patients be prepared for the procedure. We have reading materials; our nurses explain the procedure. In the office, I try to prepare the patient for success. I let her know what is going on. A friend, family member can be with her. We have a nurse that understands the procedure; she explains it well. We have a type of bed that allows the patients’ legs to rest more comfortably in the stirrups—a leg rest kind of stirrup. We use a heating pad. Some patients like to hear music. Some patients like to have aromatherapy. We are quick and efficient, and typically just talk to the patient throughout the procedure. Although some patients don’t like this explanatory, “talkative” approach—they say, “Dr. Bradley, just do the procedure. I don’t want to know you are touching the cervix. I don’t want to know that you’re prepping. Just do it.” 

But I like what we called it when I was growing up: vocal-local (talk to your patient and explain as you proceed). It’s like local anesthesia. For these procedures in the office you usually do not have to use numbing medicine or a paracervical block. Look at the patient’s age, number of years in menopause, whether or not  she has delivered vaginally, and what her cervix looks like. Does she have a sexually transmitted infection or pelvic inflammatory disease? Sometimes we will use misoprostol, my personal preference is oral, but there are data to suggest that vaginal can be of help.⁴ We suggest Motrin, Tylenol an hour or 2 before, and we always want patients to not come in on an empty stomach. There is also the option of primrose oil, a supplement, that patients buy at the drug store in the vitamin section. It’s used for cervical softening. It is taken orally.^5-7

If they want, patients can watch a video—similar to watching childbirth videos when I used to deliver babies. At some point we started putting mirrors where women could see their efforts of pushing a baby out, as it might give them more willpower to push harder. Some people don’t want to look. But the majority of women will do well in this setting. I do have a small number of women that just say, “I can’t do this in the office,” and so in those cases, they can go to the operating room. But the main idea is, even in an operating room, you are not just doing a D&C. You are still going to look inside with a hysteroscope and have a great panoramic view of what is going on, and remove a lesion with an instrument while you watch. Not a process of looking with the hysteroscope, scraping with a curettage, and thinking that you are complete. Targeted removal of focal lesions under continuous visualization is the goal.

OBG Management: Can you describe the goals of the consensus document on ending blind sampling co-created by the European Society of Gynecologic Endoscopy, AAGL, and the Global Community on Hysteroscopy? 

Dr. Bradley: Our goal for this year is to get a systematic review and guidelines paper written that speaks to what we have just talked about. We want to have as many articles about why blind sampling is not beneficial, with too many misses, and now we have new technology available. We want to speak to physicians to solve the conundrum of bleeding, with equivocal ultrasounds, equivocal saline infusion, sonograms, equivocal MRIs—be able to take a look. Let’s come up to speed like our other colleagues in other specialties that “look.” A systematic review guideline document will provide the evidence that blind  D&C is fraught with problems and how often we miss disease and its inherent risk.

We need to, by itself, for most of our patients, abandon D&C because we have too many missed diagnoses. As doctors we have to be lifelong learners. There was no robot back in the day. We were not able to do laparoscopic hysterectomies, there were no MRIs. I remember in our city, there was one CT scan. We just did not have a lot of technology. The half-life of medical knowledge used to be decades—you graduated in the ‘60s, you could be a great gynecologist for the next  30 years because there was not that much going on. When I finished in the mid to late ‘80s, there was no hysteroscopy training. But I have come to see its value, the science  behind it.

So what I say to doctors is, “We learn so many new things, we shouldn’t get stuck in just saying, ‘I didn’t do this when I was in training.’” And if your thought is, “Oh, in my practice, I don’t have that many cases,” you still need to be able to know who in your community can be a resource to your patients. As Maya Angelou says, “When you know better, you should do better.” And that’s where I am now—to be a lifelong learner, and just  do it.

Lastly, patient influence is very important. If patients ask, “How are you going to do the procedure?” it’s a driver for change. By utilizing hysteroscopy in the evaluation of the intrauterine cavity, we have the opportunity to change the face of evaluation and treatment for abnormal uterine bleeding.●

Ashbrook M, et al. Management of complicated appendicitis during pregnancy in the US. JAMA Network Open. 2022;5:e227555. doi:10.1001/jamanetworkopen.2022.7555.

Expert Commentary

Over the last decade, the management of acute appendicitis in the nonpregnant adult has evolved such that some authorities favor first-line nonoperative therapy in the appropriate candidate, including some individuals with complicated appendicitis. While the conventional teaching regarding appendicitis in pregnancy has always been immediate surgery, favorable outcomes from nonoperative management in the nonpregnant population have led to an increasing application of conservative therapy in pregnancy, particularly among patients with uncomplicated appendicitis. However, optimal management of complicated appendicitis in pregnancy is unclear, as the risks of both operative and nonoperative management can be significant.

Details about the study

This retrospective cohort study using data from the National Inpatient Sample (NIS) focuses on outcomes of various management options among pregnant women with complicated appendicitis from January 2003 to September 2015. Complicated appendicitis refers to individuals with appendiceal perforation with peritonitis (a free perforation) or phlegmon/abscess (a walled-off perforation). Women included in the study were identified using ICD-9 codes for both pregnancy and complicated appendicitis; they were categorized into 3 groups: immediate operative management, successful nonoperative management, and failed nonoperative management (defined as surgical intervention >1 day after admission). The clinical and other outcomes of interest included maternal death, preterm labor/delivery or pregnancy loss, amniotic infection, sepsis, pneumonia, antenatal hemorrhage, and premature rupture of membranes. Outcomes included are those that occurred during the hospitalization for appendicitis; outcomes that may have occurred between discharge from the appendicitis hospitalization to the delivery hospitalization are not included in this study.

A total of 8,087 pregnant women with complicated appendicitis were included in this study, of whom 954 (11.8%) had successful nonoperative management, 2,646 (32.7%) had failed nonoperative management, and 4,487 (55.5%) had immediate operative management. First, when comparing successful nonoperative management to immediate operative management, there were no differences in preterm labor/delivery or pregnancy loss, or antenatal hemorrhage; however, successful nonoperative management was also associated with higher risks of maternal infectious complications, including risks of amniotic infection, pneumonia, and sepsis. When comparing failed nonoperative management (women who required surgical intervention during the index hospitalization) to immediate operative management, failed conservative management was associated with higher risks of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, amniotic infection, pneumonia, and sepsis. For every 1 day that surgery was delayed in the group of women who failed nonoperative management, the odds of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, sepsis, amniotic infection, and pneumonia increased.

Study strengths and weaknesses

Database studies have inherent limitations that are overcome with strength in numbers. In this study, our understanding of outcomes associated with management of complicated appendicitis assumes that women were correctly identified as both being pregnant and having complicated appendicitis (as opposed to uncomplicated appendicitis but miscoded). Clinical data that may have led to selection of one management strategy over another, or specific clinical management decisions, are not possible to extract from the NIS. For instance, did nonoperative management systematically include percutaneous guided drainage if an abscess was noted, and appropriately targeted antibiotic therapy? If delayed operative intervention with IV antibiotics to allow for “cooling off” of the abdomen prior to surgery was planned, this strategy would have been included in the failed nonoperative management group, when in fact nonoperative management was never the plan. Whether gestational age (which is not known in this study), or any other clinical data contributed to the initially chosen management strategy is not known.

The treating clinicians, obstetricians and surgeons alike, would like to know the pregnancy outcome when considering the various management strategies for complicated appendicitis. However, this study only provides insight into the outcomes for the hospitalization for appendicitis. Whether or not women categorized as successful nonoperative management go on to require surgery or have preterm labor in the future, or whether women with successful immediate surgical management might be readmitted with complications, is not known. This is a significant limitation of the database, which does not allow for linking of individual hospitalizations, and rather can provide only a snapshot in time.

This study includes a fairly long timespan–2003 to 2015–during which the management of complicated appendicitis was actively evolving. Early in this time frame, nonoperative management outside of pregnancy was uncommon, and nonoperative management may have been even rarer and perhaps reserved for the most ill of pregnant women on presentation (for whom surgery may have been considered too risky without a short time with IV antibiotics to “cool off” the abdomen). As time progressed over the study span, nonoperative management was likely offered with greater frequency and among women with lesser degrees of illness. However, the year of presentation was not controlled for in this study.

Finally, given the differences noted in management strategy by race/ethnicity and type of hospital, it is not clear how this bias influences the findings from this study. ●

Ashbrook M, et al. Management of complicated appendicitis during pregnancy in the US. JAMA Network Open. 2022;5:e227555. doi:10.1001/jamanetworkopen.2022.7555.

Expert Commentary

Over the last decade, the management of acute appendicitis in the nonpregnant adult has evolved such that some authorities favor first-line nonoperative therapy in the appropriate candidate, including some individuals with complicated appendicitis. While the conventional teaching regarding appendicitis in pregnancy has always been immediate surgery, favorable outcomes from nonoperative management in the nonpregnant population have led to an increasing application of conservative therapy in pregnancy, particularly among patients with uncomplicated appendicitis. However, optimal management of complicated appendicitis in pregnancy is unclear, as the risks of both operative and nonoperative management can be significant.

Details about the study

This retrospective cohort study using data from the National Inpatient Sample (NIS) focuses on outcomes of various management options among pregnant women with complicated appendicitis from January 2003 to September 2015. Complicated appendicitis refers to individuals with appendiceal perforation with peritonitis (a free perforation) or phlegmon/abscess (a walled-off perforation). Women included in the study were identified using ICD-9 codes for both pregnancy and complicated appendicitis; they were categorized into 3 groups: immediate operative management, successful nonoperative management, and failed nonoperative management (defined as surgical intervention >1 day after admission). The clinical and other outcomes of interest included maternal death, preterm labor/delivery or pregnancy loss, amniotic infection, sepsis, pneumonia, antenatal hemorrhage, and premature rupture of membranes. Outcomes included are those that occurred during the hospitalization for appendicitis; outcomes that may have occurred between discharge from the appendicitis hospitalization to the delivery hospitalization are not included in this study.

A total of 8,087 pregnant women with complicated appendicitis were included in this study, of whom 954 (11.8%) had successful nonoperative management, 2,646 (32.7%) had failed nonoperative management, and 4,487 (55.5%) had immediate operative management. First, when comparing successful nonoperative management to immediate operative management, there were no differences in preterm labor/delivery or pregnancy loss, or antenatal hemorrhage; however, successful nonoperative management was also associated with higher risks of maternal infectious complications, including risks of amniotic infection, pneumonia, and sepsis. When comparing failed nonoperative management (women who required surgical intervention during the index hospitalization) to immediate operative management, failed conservative management was associated with higher risks of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, amniotic infection, pneumonia, and sepsis. For every 1 day that surgery was delayed in the group of women who failed nonoperative management, the odds of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, sepsis, amniotic infection, and pneumonia increased.

Study strengths and weaknesses

Database studies have inherent limitations that are overcome with strength in numbers. In this study, our understanding of outcomes associated with management of complicated appendicitis assumes that women were correctly identified as both being pregnant and having complicated appendicitis (as opposed to uncomplicated appendicitis but miscoded). Clinical data that may have led to selection of one management strategy over another, or specific clinical management decisions, are not possible to extract from the NIS. For instance, did nonoperative management systematically include percutaneous guided drainage if an abscess was noted, and appropriately targeted antibiotic therapy? If delayed operative intervention with IV antibiotics to allow for “cooling off” of the abdomen prior to surgery was planned, this strategy would have been included in the failed nonoperative management group, when in fact nonoperative management was never the plan. Whether gestational age (which is not known in this study), or any other clinical data contributed to the initially chosen management strategy is not known.

The treating clinicians, obstetricians and surgeons alike, would like to know the pregnancy outcome when considering the various management strategies for complicated appendicitis. However, this study only provides insight into the outcomes for the hospitalization for appendicitis. Whether or not women categorized as successful nonoperative management go on to require surgery or have preterm labor in the future, or whether women with successful immediate surgical management might be readmitted with complications, is not known. This is a significant limitation of the database, which does not allow for linking of individual hospitalizations, and rather can provide only a snapshot in time.

This study includes a fairly long timespan–2003 to 2015–during which the management of complicated appendicitis was actively evolving. Early in this time frame, nonoperative management outside of pregnancy was uncommon, and nonoperative management may have been even rarer and perhaps reserved for the most ill of pregnant women on presentation (for whom surgery may have been considered too risky without a short time with IV antibiotics to “cool off” the abdomen). As time progressed over the study span, nonoperative management was likely offered with greater frequency and among women with lesser degrees of illness. However, the year of presentation was not controlled for in this study.

Finally, given the differences noted in management strategy by race/ethnicity and type of hospital, it is not clear how this bias influences the findings from this study. ●

Ashbrook M, et al. Management of complicated appendicitis during pregnancy in the US. JAMA Network Open. 2022;5:e227555. doi:10.1001/jamanetworkopen.2022.7555.

Expert Commentary

Over the last decade, the management of acute appendicitis in the nonpregnant adult has evolved such that some authorities favor first-line nonoperative therapy in the appropriate candidate, including some individuals with complicated appendicitis. While the conventional teaching regarding appendicitis in pregnancy has always been immediate surgery, favorable outcomes from nonoperative management in the nonpregnant population have led to an increasing application of conservative therapy in pregnancy, particularly among patients with uncomplicated appendicitis. However, optimal management of complicated appendicitis in pregnancy is unclear, as the risks of both operative and nonoperative management can be significant.

Details about the study

This retrospective cohort study using data from the National Inpatient Sample (NIS) focuses on outcomes of various management options among pregnant women with complicated appendicitis from January 2003 to September 2015. Complicated appendicitis refers to individuals with appendiceal perforation with peritonitis (a free perforation) or phlegmon/abscess (a walled-off perforation). Women included in the study were identified using ICD-9 codes for both pregnancy and complicated appendicitis; they were categorized into 3 groups: immediate operative management, successful nonoperative management, and failed nonoperative management (defined as surgical intervention >1 day after admission). The clinical and other outcomes of interest included maternal death, preterm labor/delivery or pregnancy loss, amniotic infection, sepsis, pneumonia, antenatal hemorrhage, and premature rupture of membranes. Outcomes included are those that occurred during the hospitalization for appendicitis; outcomes that may have occurred between discharge from the appendicitis hospitalization to the delivery hospitalization are not included in this study.

A total of 8,087 pregnant women with complicated appendicitis were included in this study, of whom 954 (11.8%) had successful nonoperative management, 2,646 (32.7%) had failed nonoperative management, and 4,487 (55.5%) had immediate operative management. First, when comparing successful nonoperative management to immediate operative management, there were no differences in preterm labor/delivery or pregnancy loss, or antenatal hemorrhage; however, successful nonoperative management was also associated with higher risks of maternal infectious complications, including risks of amniotic infection, pneumonia, and sepsis. When comparing failed nonoperative management (women who required surgical intervention during the index hospitalization) to immediate operative management, failed conservative management was associated with higher risks of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, amniotic infection, pneumonia, and sepsis. For every 1 day that surgery was delayed in the group of women who failed nonoperative management, the odds of preterm labor/delivery or pregnancy loss, antenatal hemorrhage, sepsis, amniotic infection, and pneumonia increased.

Study strengths and weaknesses

Database studies have inherent limitations that are overcome with strength in numbers. In this study, our understanding of outcomes associated with management of complicated appendicitis assumes that women were correctly identified as both being pregnant and having complicated appendicitis (as opposed to uncomplicated appendicitis but miscoded). Clinical data that may have led to selection of one management strategy over another, or specific clinical management decisions, are not possible to extract from the NIS. For instance, did nonoperative management systematically include percutaneous guided drainage if an abscess was noted, and appropriately targeted antibiotic therapy? If delayed operative intervention with IV antibiotics to allow for “cooling off” of the abdomen prior to surgery was planned, this strategy would have been included in the failed nonoperative management group, when in fact nonoperative management was never the plan. Whether gestational age (which is not known in this study), or any other clinical data contributed to the initially chosen management strategy is not known.

The treating clinicians, obstetricians and surgeons alike, would like to know the pregnancy outcome when considering the various management strategies for complicated appendicitis. However, this study only provides insight into the outcomes for the hospitalization for appendicitis. Whether or not women categorized as successful nonoperative management go on to require surgery or have preterm labor in the future, or whether women with successful immediate surgical management might be readmitted with complications, is not known. This is a significant limitation of the database, which does not allow for linking of individual hospitalizations, and rather can provide only a snapshot in time.

This study includes a fairly long timespan–2003 to 2015–during which the management of complicated appendicitis was actively evolving. Early in this time frame, nonoperative management outside of pregnancy was uncommon, and nonoperative management may have been even rarer and perhaps reserved for the most ill of pregnant women on presentation (for whom surgery may have been considered too risky without a short time with IV antibiotics to “cool off” the abdomen). As time progressed over the study span, nonoperative management was likely offered with greater frequency and among women with lesser degrees of illness. However, the year of presentation was not controlled for in this study.

Finally, given the differences noted in management strategy by race/ethnicity and type of hospital, it is not clear how this bias influences the findings from this study. ●

It is time to reconsider the recommendation for practicing fetal kick counts. A meta-analysis demonstrated no decrease in the outcome of stillbirth, but instead an increased risk of iatrogenic delivery.¹

CASE 1 8 vs 10 fetal movements in 2 hours

Ms. M is 38 weeks pregnant with an uncomplicated pregnancy. She calls your practice with concerns about fetal kick counts. During her prenatal care, she was counseled to ensure that the baby moved 10 times over a period of 2 hours. This morning, however, she only perceived 8 movements in 2 hours. She is scheduled for evaluation with a nonstress test (NST) on the labor and delivery unit. The NST reveals a reassuring, reactive tracing. Ultrasonography evaluation demonstrates a normal amniotic fluid index and normal fetal growth. The patient is reassured, returns home, and goes on to deliver a healthy baby at 39 weeks and 5 days.

Perception of decreased movement triggers evaluation and monitoring

Maternal perception of normal fetal movement has conceivably been used throughout history as a means of reassurance of fetal well-being; it is highly predictive of fetal viability.^2,3 When fetal movement is lacking or decreased, it can be an alarm sign and may result in concerns by the mother that her baby is unwell. Maternal perception of decreased fetal movements affects 5% to 15% of all pregnancies.^2,4 While decreased fetal movement can be associated with poor perinatal outcomes such as fetal growth restriction, oligohydramnios, and neuro-developmental disability, it also can be reflective of more benign issues such as anterior placenta, maternal activity, maternal caffeine or sugar consumption, or maternal position.^4,5

However, the definition of decreased fetal movement is subject to significant variation, from a total absence of movement over an entire day or what has commonly become accepted as the definition of fetal kick counts with Pearson’s Cardiff chart (which was defined in the 1970s as 10 movements within 12 hours).^6,7 Today, women in the United States are commonly recommended to monitor their baby over a 2-hour period and to look for 10 movements during that time.⁸ Anything less is considered reduced fetal movement and results in recommendations to undergo assessment of previously known high-risk conditions or any possible underlying conditions, such as hypertension, gestational diabetes, or fetal growth restriction. Further evaluation with more objective measures such as electronic fetal monitoring or ultrasonography with biophysical profile are often recommended concurrently.⁹

It is estimated that up to 15% of women present reporting decreased fetal movement in the third trimester and, as such, require additional monitoring and evaluation. This is not without cost of time and money to the health care system and pregnant patients.

It is uncertain that fetal kick counting prevents stillbirth

Intrauterine fetal demise is neither an uncommon nor completely preventable outcome, despite advances in antenatal care. Many cases occur without evidence of fetal abnormality or other risk factors, and 30% to 55% of women who experience intrauterine fetal demise experience decreased fetal movement in the preceding week.¹⁰ It makes physiologic sense that a fetus’ adaptive response to decreased oxygenation is reduced fetal movement, resulting from the prioritization of blood to the fetal brain and other organs over skeletal muscle.^4,9,11 Results of a 1976 small study of 61 low-risk pregnancies seemed to confirm that a decrease in fetal movement preceded intrauterine death by 3 to 4 days. Conversely, they found that a normal fetal movement count was generally associated with a good neonatal outcome.⁶ Thus, experts have long extrapolated that decreased fetal movement can be an indicator for utero-placental insufficiency and, in turn, chronic or acute hypoxia.

However, in larger studies, the ability of fetal movement counting to predict fetal death and fetal compromise appears limited.^8,10,11 A meta-analysis of studies, including 5 randomized controlled trials and 468,000 fetuses, compared the incidence of stillbirth in women receiving instructions for fetal movement counting versus women who did not. Rates of stillbirth were the same for each group, demonstrating no advantage to fetal kick counts to prevent a poor perinatal outcome, including stillbirth.¹

CASE 2 Reported reduced fetal movement over 4 weeks

Ms. E is a 20-year-old nullipara at 36 weeks’ and 6 days gestation who has come in to triage weekly for the last 4 weeks with concerns about decreased fetal movement. She states that she goes for several hours each day without feeling 10 movements in 2 hours. Recent fetal growth recorded 3 weeks ago was in the 45th percentile, and the amniotic fluid index has been above 10 cm on each weekly ultrasound. Her weekly NSTs have been reactive, and she has been normotensive. However, because she has had several weeks of persistent decreased fetal movement, the labor and delivery team opts to keep her for induction as she is “close to term.”

Decreased kick count frequency may increase unnecessary interventions

Women with fewer kick counts are more likely to present with concerns about the well-being of their baby. In a survey of obstetricians and midwives, a large proportion of providers were more apt to recommend delivery or admission to the hospital for women presenting with decreased fetal movements.² It stands to reason that recommendations for delivery or admission can lead to outcomes like preterm delivery or recommendations for cesarean delivery (CD). However, using fetal kick counts to portend stillbirth or other poor fetal and neonatal outcomes has been shown to be limited in its value with the AFFIRM trial.¹⁰ The results of this large study, which included more than 400,000 pregnancies from 37 hospitals, show the challenges of any study to address the use of management strategies for recent change in the frequency of fetal movements in the reduction of and cause of stillbirth. Additionally, the relatively low risk of stillbirth overall (4.06 stillbirths per 1,000 livebirths during the intervention period and 4.40 per 1,000 livebirths during the control period) but higher incidence of other outcomes, such as prolonged (>48 hours) antepartum admission (6.7% in the intervention period and 6.2% in the control period), induction of labor (40.7% in the intervention period and 35.9% in the control period), and CD (28.4% and 25.5%, respectively) may result in increased harm for many women rather than the intended benefit of preventing stillbirth.^10,12

Mindfetalness may be a viable and valuable alternative to kick counts

Alternatives have been proposed as a measure of fetal movement without using kick counts specifically. Mindfetalness has been a method studied in Sweden; its purpose is to strengthen the mother’s awareness of her baby through developing an understanding of the fetal-movement pattern. It is practiced starting at 28 weeks’ gestation for 15 minutes a day, with the woman instructed to lie on her left side and discern the intensity and character of the movements, as well as frequency, without overtly counting the movements.¹² In one small study, women felt more connected to their babies and felt less worried.¹² In a much larger study of 13,000 women, the authors found no evidence of harm from generalized awareness of fetal movements in a population of pregnant women at or beyond 32 weeks; in fact, they did see significant reductions in iatrogenic outcomes such as CDs and labor inductions.¹³

The case for movement awareness over kick counts

Stillbirth risk does not appear to be modified by the use of methods to detect fetal movement.^10,12 However, a perceived decrease in fetal kick counts has been shown to result in increased interventions and preterm deliveries. A more prudent approach appears to be educating mothers about general fetal movement, which appears to reduce potentially unnecessary visits and interventions without sacrificing the ability to reassure mothers about the well-being of their babies in utero. ●

It is time to reconsider the recommendation for practicing fetal kick counts. A meta-analysis demonstrated no decrease in the outcome of stillbirth, but instead an increased risk of iatrogenic delivery.¹

CASE 1 8 vs 10 fetal movements in 2 hours

Ms. M is 38 weeks pregnant with an uncomplicated pregnancy. She calls your practice with concerns about fetal kick counts. During her prenatal care, she was counseled to ensure that the baby moved 10 times over a period of 2 hours. This morning, however, she only perceived 8 movements in 2 hours. She is scheduled for evaluation with a nonstress test (NST) on the labor and delivery unit. The NST reveals a reassuring, reactive tracing. Ultrasonography evaluation demonstrates a normal amniotic fluid index and normal fetal growth. The patient is reassured, returns home, and goes on to deliver a healthy baby at 39 weeks and 5 days.

Perception of decreased movement triggers evaluation and monitoring

Maternal perception of normal fetal movement has conceivably been used throughout history as a means of reassurance of fetal well-being; it is highly predictive of fetal viability.^2,3 When fetal movement is lacking or decreased, it can be an alarm sign and may result in concerns by the mother that her baby is unwell. Maternal perception of decreased fetal movements affects 5% to 15% of all pregnancies.^2,4 While decreased fetal movement can be associated with poor perinatal outcomes such as fetal growth restriction, oligohydramnios, and neuro-developmental disability, it also can be reflective of more benign issues such as anterior placenta, maternal activity, maternal caffeine or sugar consumption, or maternal position.^4,5

However, the definition of decreased fetal movement is subject to significant variation, from a total absence of movement over an entire day or what has commonly become accepted as the definition of fetal kick counts with Pearson’s Cardiff chart (which was defined in the 1970s as 10 movements within 12 hours).^6,7 Today, women in the United States are commonly recommended to monitor their baby over a 2-hour period and to look for 10 movements during that time.⁸ Anything less is considered reduced fetal movement and results in recommendations to undergo assessment of previously known high-risk conditions or any possible underlying conditions, such as hypertension, gestational diabetes, or fetal growth restriction. Further evaluation with more objective measures such as electronic fetal monitoring or ultrasonography with biophysical profile are often recommended concurrently.⁹

It is estimated that up to 15% of women present reporting decreased fetal movement in the third trimester and, as such, require additional monitoring and evaluation. This is not without cost of time and money to the health care system and pregnant patients.

It is uncertain that fetal kick counting prevents stillbirth

Intrauterine fetal demise is neither an uncommon nor completely preventable outcome, despite advances in antenatal care. Many cases occur without evidence of fetal abnormality or other risk factors, and 30% to 55% of women who experience intrauterine fetal demise experience decreased fetal movement in the preceding week.¹⁰ It makes physiologic sense that a fetus’ adaptive response to decreased oxygenation is reduced fetal movement, resulting from the prioritization of blood to the fetal brain and other organs over skeletal muscle.^4,9,11 Results of a 1976 small study of 61 low-risk pregnancies seemed to confirm that a decrease in fetal movement preceded intrauterine death by 3 to 4 days. Conversely, they found that a normal fetal movement count was generally associated with a good neonatal outcome.⁶ Thus, experts have long extrapolated that decreased fetal movement can be an indicator for utero-placental insufficiency and, in turn, chronic or acute hypoxia.

However, in larger studies, the ability of fetal movement counting to predict fetal death and fetal compromise appears limited.^8,10,11 A meta-analysis of studies, including 5 randomized controlled trials and 468,000 fetuses, compared the incidence of stillbirth in women receiving instructions for fetal movement counting versus women who did not. Rates of stillbirth were the same for each group, demonstrating no advantage to fetal kick counts to prevent a poor perinatal outcome, including stillbirth.¹

CASE 2 Reported reduced fetal movement over 4 weeks

Ms. E is a 20-year-old nullipara at 36 weeks’ and 6 days gestation who has come in to triage weekly for the last 4 weeks with concerns about decreased fetal movement. She states that she goes for several hours each day without feeling 10 movements in 2 hours. Recent fetal growth recorded 3 weeks ago was in the 45th percentile, and the amniotic fluid index has been above 10 cm on each weekly ultrasound. Her weekly NSTs have been reactive, and she has been normotensive. However, because she has had several weeks of persistent decreased fetal movement, the labor and delivery team opts to keep her for induction as she is “close to term.”

Decreased kick count frequency may increase unnecessary interventions

Women with fewer kick counts are more likely to present with concerns about the well-being of their baby. In a survey of obstetricians and midwives, a large proportion of providers were more apt to recommend delivery or admission to the hospital for women presenting with decreased fetal movements.² It stands to reason that recommendations for delivery or admission can lead to outcomes like preterm delivery or recommendations for cesarean delivery (CD). However, using fetal kick counts to portend stillbirth or other poor fetal and neonatal outcomes has been shown to be limited in its value with the AFFIRM trial.¹⁰ The results of this large study, which included more than 400,000 pregnancies from 37 hospitals, show the challenges of any study to address the use of management strategies for recent change in the frequency of fetal movements in the reduction of and cause of stillbirth. Additionally, the relatively low risk of stillbirth overall (4.06 stillbirths per 1,000 livebirths during the intervention period and 4.40 per 1,000 livebirths during the control period) but higher incidence of other outcomes, such as prolonged (>48 hours) antepartum admission (6.7% in the intervention period and 6.2% in the control period), induction of labor (40.7% in the intervention period and 35.9% in the control period), and CD (28.4% and 25.5%, respectively) may result in increased harm for many women rather than the intended benefit of preventing stillbirth.^10,12

Mindfetalness may be a viable and valuable alternative to kick counts

Alternatives have been proposed as a measure of fetal movement without using kick counts specifically. Mindfetalness has been a method studied in Sweden; its purpose is to strengthen the mother’s awareness of her baby through developing an understanding of the fetal-movement pattern. It is practiced starting at 28 weeks’ gestation for 15 minutes a day, with the woman instructed to lie on her left side and discern the intensity and character of the movements, as well as frequency, without overtly counting the movements.¹² In one small study, women felt more connected to their babies and felt less worried.¹² In a much larger study of 13,000 women, the authors found no evidence of harm from generalized awareness of fetal movements in a population of pregnant women at or beyond 32 weeks; in fact, they did see significant reductions in iatrogenic outcomes such as CDs and labor inductions.¹³

The case for movement awareness over kick counts

Stillbirth risk does not appear to be modified by the use of methods to detect fetal movement.^10,12 However, a perceived decrease in fetal kick counts has been shown to result in increased interventions and preterm deliveries. A more prudent approach appears to be educating mothers about general fetal movement, which appears to reduce potentially unnecessary visits and interventions without sacrificing the ability to reassure mothers about the well-being of their babies in utero. ●

It is time to reconsider the recommendation for practicing fetal kick counts. A meta-analysis demonstrated no decrease in the outcome of stillbirth, but instead an increased risk of iatrogenic delivery.¹

CASE 1 8 vs 10 fetal movements in 2 hours

Ms. M is 38 weeks pregnant with an uncomplicated pregnancy. She calls your practice with concerns about fetal kick counts. During her prenatal care, she was counseled to ensure that the baby moved 10 times over a period of 2 hours. This morning, however, she only perceived 8 movements in 2 hours. She is scheduled for evaluation with a nonstress test (NST) on the labor and delivery unit. The NST reveals a reassuring, reactive tracing. Ultrasonography evaluation demonstrates a normal amniotic fluid index and normal fetal growth. The patient is reassured, returns home, and goes on to deliver a healthy baby at 39 weeks and 5 days.

Perception of decreased movement triggers evaluation and monitoring

Maternal perception of normal fetal movement has conceivably been used throughout history as a means of reassurance of fetal well-being; it is highly predictive of fetal viability.^2,3 When fetal movement is lacking or decreased, it can be an alarm sign and may result in concerns by the mother that her baby is unwell. Maternal perception of decreased fetal movements affects 5% to 15% of all pregnancies.^2,4 While decreased fetal movement can be associated with poor perinatal outcomes such as fetal growth restriction, oligohydramnios, and neuro-developmental disability, it also can be reflective of more benign issues such as anterior placenta, maternal activity, maternal caffeine or sugar consumption, or maternal position.^4,5

However, the definition of decreased fetal movement is subject to significant variation, from a total absence of movement over an entire day or what has commonly become accepted as the definition of fetal kick counts with Pearson’s Cardiff chart (which was defined in the 1970s as 10 movements within 12 hours).^6,7 Today, women in the United States are commonly recommended to monitor their baby over a 2-hour period and to look for 10 movements during that time.⁸ Anything less is considered reduced fetal movement and results in recommendations to undergo assessment of previously known high-risk conditions or any possible underlying conditions, such as hypertension, gestational diabetes, or fetal growth restriction. Further evaluation with more objective measures such as electronic fetal monitoring or ultrasonography with biophysical profile are often recommended concurrently.⁹

It is estimated that up to 15% of women present reporting decreased fetal movement in the third trimester and, as such, require additional monitoring and evaluation. This is not without cost of time and money to the health care system and pregnant patients.

It is uncertain that fetal kick counting prevents stillbirth

Intrauterine fetal demise is neither an uncommon nor completely preventable outcome, despite advances in antenatal care. Many cases occur without evidence of fetal abnormality or other risk factors, and 30% to 55% of women who experience intrauterine fetal demise experience decreased fetal movement in the preceding week.¹⁰ It makes physiologic sense that a fetus’ adaptive response to decreased oxygenation is reduced fetal movement, resulting from the prioritization of blood to the fetal brain and other organs over skeletal muscle.^4,9,11 Results of a 1976 small study of 61 low-risk pregnancies seemed to confirm that a decrease in fetal movement preceded intrauterine death by 3 to 4 days. Conversely, they found that a normal fetal movement count was generally associated with a good neonatal outcome.⁶ Thus, experts have long extrapolated that decreased fetal movement can be an indicator for utero-placental insufficiency and, in turn, chronic or acute hypoxia.

However, in larger studies, the ability of fetal movement counting to predict fetal death and fetal compromise appears limited.^8,10,11 A meta-analysis of studies, including 5 randomized controlled trials and 468,000 fetuses, compared the incidence of stillbirth in women receiving instructions for fetal movement counting versus women who did not. Rates of stillbirth were the same for each group, demonstrating no advantage to fetal kick counts to prevent a poor perinatal outcome, including stillbirth.¹

CASE 2 Reported reduced fetal movement over 4 weeks

Ms. E is a 20-year-old nullipara at 36 weeks’ and 6 days gestation who has come in to triage weekly for the last 4 weeks with concerns about decreased fetal movement. She states that she goes for several hours each day without feeling 10 movements in 2 hours. Recent fetal growth recorded 3 weeks ago was in the 45th percentile, and the amniotic fluid index has been above 10 cm on each weekly ultrasound. Her weekly NSTs have been reactive, and she has been normotensive. However, because she has had several weeks of persistent decreased fetal movement, the labor and delivery team opts to keep her for induction as she is “close to term.”

Decreased kick count frequency may increase unnecessary interventions

Women with fewer kick counts are more likely to present with concerns about the well-being of their baby. In a survey of obstetricians and midwives, a large proportion of providers were more apt to recommend delivery or admission to the hospital for women presenting with decreased fetal movements.² It stands to reason that recommendations for delivery or admission can lead to outcomes like preterm delivery or recommendations for cesarean delivery (CD). However, using fetal kick counts to portend stillbirth or other poor fetal and neonatal outcomes has been shown to be limited in its value with the AFFIRM trial.¹⁰ The results of this large study, which included more than 400,000 pregnancies from 37 hospitals, show the challenges of any study to address the use of management strategies for recent change in the frequency of fetal movements in the reduction of and cause of stillbirth. Additionally, the relatively low risk of stillbirth overall (4.06 stillbirths per 1,000 livebirths during the intervention period and 4.40 per 1,000 livebirths during the control period) but higher incidence of other outcomes, such as prolonged (>48 hours) antepartum admission (6.7% in the intervention period and 6.2% in the control period), induction of labor (40.7% in the intervention period and 35.9% in the control period), and CD (28.4% and 25.5%, respectively) may result in increased harm for many women rather than the intended benefit of preventing stillbirth.^10,12

Mindfetalness may be a viable and valuable alternative to kick counts

Alternatives have been proposed as a measure of fetal movement without using kick counts specifically. Mindfetalness has been a method studied in Sweden; its purpose is to strengthen the mother’s awareness of her baby through developing an understanding of the fetal-movement pattern. It is practiced starting at 28 weeks’ gestation for 15 minutes a day, with the woman instructed to lie on her left side and discern the intensity and character of the movements, as well as frequency, without overtly counting the movements.¹² In one small study, women felt more connected to their babies and felt less worried.¹² In a much larger study of 13,000 women, the authors found no evidence of harm from generalized awareness of fetal movements in a population of pregnant women at or beyond 32 weeks; in fact, they did see significant reductions in iatrogenic outcomes such as CDs and labor inductions.¹³

The case for movement awareness over kick counts

Stillbirth risk does not appear to be modified by the use of methods to detect fetal movement.^10,12 However, a perceived decrease in fetal kick counts has been shown to result in increased interventions and preterm deliveries. A more prudent approach appears to be educating mothers about general fetal movement, which appears to reduce potentially unnecessary visits and interventions without sacrificing the ability to reassure mothers about the well-being of their babies in utero. ●

Abdel-Fattah M, Cooper D, Davidson T, et al. Single-incision mini-slings for stress urinary incontinence in women. N Engl J Med. 2022;386:1230-1243.

EXPERT COMMENTARY

A joint society position statement by the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction published in December 2021 declared synthetic midurethral slings, first cleared for use in the United States in the early 1990s, the most extensively studied anti-incontinence operation and the standard of care for the treatment of female stress urinary incontinence.¹ Full-length retropubic and transobturator (out-in and in-out) slings have been extensively evaluated for safety and efficacy in well-conducted randomized trials.² Single-incision mini-slings (SIMS) were first cleared for use in 2006, but they lack the long-term safety and comparative effectiveness data of full-length standard midurethral slings (SMUS).³ Furthermore, several iterations of the mini-slings have come to market but have been withdrawn or modified to allow for adjustability.

The SIMS trial by Abdel-Fattah and colleagues, published recently in the New England Journal of Medicine, is one of the few randomized trials with long-term (3 year) subjective and objective outcome data based on comparison of adjustable single-incision mini-slings versus standard full-length midurethral slings.

Details of the study

The SIMS trial is a noninferiority multicenter randomized controlled trial funded by the National Institute for Health Research at 21 hospitals in the United Kingdom that compared adjustable mini-sling procedures performed under local anesthesia with full-length retrotropubic and transobturator sling procedures performed under general anesthesia. Patients and surgeons were not masked to study group assignment because of the differences in anesthesia, and patients with greater than stage 2 prolapse were excluded from the trial.

The primary outcome was Patient Global Impression of Improvement (PGI-I) based on a 7-point Likert scale, with success defined as very much improved or much improved at 15 months and failure defined as all other responses (improved, same, worse, much worse, and very much worse). A noninferiority margin was set at 10 percentage points at 15 months.

Secondary outcomes and adverse events at 36 months included postoperative pain, return to normal activities, objective success based on a 24-hour pad test weight of less than 8 g, and tape exposure, organ injury, new or worsening urinary urgency, dyspareunia, and need for prolonged catheterization.

A total of 596 women were enrolled in the study, 298 in the mini-sling arm and 298 in the standard midurethral sling arm. Baseline characteristics were similar in both groups with most sling procedures being performed by general consultant gynecologists (>60%) versus subspecialist urogynecologists.

Results. Success at 15 months, based on the PGI-I responses of very much better or much better, was noted in 79.1% of patients in the mini-sling group (212/268) versus 75.6% in the full-length sling group (189/250). The authors deemed mini-slings noninferior to standard full-length slings (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<.001 for noninferiority). Success rates declined but remained similar in both groups at 36 months: 72% in the mini-sling group (177/246) and 66.8% (157/235) in the full-length sling group.

More than 70% of mini-incision slings were Altis (Coloplast) and 22% were Ajust (CR Bard; since withdrawn from the market). The majority of standard midurethral full-length slings were transobturator slings (52.9%) versus retropubic slings (35.6%).

While blood loss, organ injury, and 36-month objective 24-hour pad test did not differ between groups, there were significant differences in other secondary outcomes. Dyspareunia and coital incontinence were more common with mini-slings at 15 and 36 months, reported in 11.7% of the mini-sling group and 4.8% of the full-length group (P<.01). Groin or thigh pain did not differ significantly between groups at 36 months (14.1% in mini-sling and 14.9% in full-length sling group, P = .61). Mesh exposure was noted in 3.3% of those with mini-slings and 1.9% of those with standard midurethral slings. The need for surgical intervention to treat recurrent stress incontinence or mesh removal for voiding dysfunction, pain, or mesh exposure also did not differ between groups (8.7% of the mini-sling group and 4.6% of the midurethral sling group; P = .12).

Study strengths and limitations

The strengths of this pragmatic randomized trial are in the use of clinically important and validated patient-reported subjective and objective outcomes in an adequately powered multisite trial of long duration (36 months). This study is important in demonstrating noninferiority of the mini-sling procedure compared with full-length slings, especially given this trial’s timing when there was a pause or suspension of sling mesh use in the United Kingdom beginning in 2018.

Study limitations include the loss to follow-up with diminished response rate of 87.1% at 15 months and 81.4% at 36 months and the inability to adequately assess for the uncommon outcomes, such as mesh-related complications and groin pain.

Further analysis needed

The high rate of dyspareunia (11.7%) with mini-slings deserves further analysis and consideration of whether or not to implant them in patients who are sexually active. Groin or thigh pain did not differ at 36 months but reported pain coincided with the higher percentage of transobturator slings placed over retropubic slings. Prior randomized trials of transobturator versus retropubic midurethral slings have demonstrated this same phenomenon of increased groin pain with the transobturator approach.² Furthermore, this study by Abdel-Fattah and colleagues excluded patients with advanced anterior or apical prolapse, but one trial is currently underway in the United States.⁴

In conclusion, this trial suggests some advantages of single-incision mini-slings—ability to perform the procedure under local anesthesia, less synthetic mesh implantation with theoretically decreased risk of bladder perforation or bowel injury, and potential for easier removal compared with full-length slings. Disadvantages include dyspareunia and mesh exposure, which could be significant trade-offs for patients. ●

Abdel-Fattah M, Cooper D, Davidson T, et al. Single-incision mini-slings for stress urinary incontinence in women. N Engl J Med. 2022;386:1230-1243.

EXPERT COMMENTARY

A joint society position statement by the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction published in December 2021 declared synthetic midurethral slings, first cleared for use in the United States in the early 1990s, the most extensively studied anti-incontinence operation and the standard of care for the treatment of female stress urinary incontinence.¹ Full-length retropubic and transobturator (out-in and in-out) slings have been extensively evaluated for safety and efficacy in well-conducted randomized trials.² Single-incision mini-slings (SIMS) were first cleared for use in 2006, but they lack the long-term safety and comparative effectiveness data of full-length standard midurethral slings (SMUS).³ Furthermore, several iterations of the mini-slings have come to market but have been withdrawn or modified to allow for adjustability.

The SIMS trial by Abdel-Fattah and colleagues, published recently in the New England Journal of Medicine, is one of the few randomized trials with long-term (3 year) subjective and objective outcome data based on comparison of adjustable single-incision mini-slings versus standard full-length midurethral slings.

Details of the study

The SIMS trial is a noninferiority multicenter randomized controlled trial funded by the National Institute for Health Research at 21 hospitals in the United Kingdom that compared adjustable mini-sling procedures performed under local anesthesia with full-length retrotropubic and transobturator sling procedures performed under general anesthesia. Patients and surgeons were not masked to study group assignment because of the differences in anesthesia, and patients with greater than stage 2 prolapse were excluded from the trial.

The primary outcome was Patient Global Impression of Improvement (PGI-I) based on a 7-point Likert scale, with success defined as very much improved or much improved at 15 months and failure defined as all other responses (improved, same, worse, much worse, and very much worse). A noninferiority margin was set at 10 percentage points at 15 months.

Secondary outcomes and adverse events at 36 months included postoperative pain, return to normal activities, objective success based on a 24-hour pad test weight of less than 8 g, and tape exposure, organ injury, new or worsening urinary urgency, dyspareunia, and need for prolonged catheterization.

A total of 596 women were enrolled in the study, 298 in the mini-sling arm and 298 in the standard midurethral sling arm. Baseline characteristics were similar in both groups with most sling procedures being performed by general consultant gynecologists (>60%) versus subspecialist urogynecologists.

Results. Success at 15 months, based on the PGI-I responses of very much better or much better, was noted in 79.1% of patients in the mini-sling group (212/268) versus 75.6% in the full-length sling group (189/250). The authors deemed mini-slings noninferior to standard full-length slings (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<.001 for noninferiority). Success rates declined but remained similar in both groups at 36 months: 72% in the mini-sling group (177/246) and 66.8% (157/235) in the full-length sling group.

More than 70% of mini-incision slings were Altis (Coloplast) and 22% were Ajust (CR Bard; since withdrawn from the market). The majority of standard midurethral full-length slings were transobturator slings (52.9%) versus retropubic slings (35.6%).

While blood loss, organ injury, and 36-month objective 24-hour pad test did not differ between groups, there were significant differences in other secondary outcomes. Dyspareunia and coital incontinence were more common with mini-slings at 15 and 36 months, reported in 11.7% of the mini-sling group and 4.8% of the full-length group (P<.01). Groin or thigh pain did not differ significantly between groups at 36 months (14.1% in mini-sling and 14.9% in full-length sling group, P = .61). Mesh exposure was noted in 3.3% of those with mini-slings and 1.9% of those with standard midurethral slings. The need for surgical intervention to treat recurrent stress incontinence or mesh removal for voiding dysfunction, pain, or mesh exposure also did not differ between groups (8.7% of the mini-sling group and 4.6% of the midurethral sling group; P = .12).

Study strengths and limitations

The strengths of this pragmatic randomized trial are in the use of clinically important and validated patient-reported subjective and objective outcomes in an adequately powered multisite trial of long duration (36 months). This study is important in demonstrating noninferiority of the mini-sling procedure compared with full-length slings, especially given this trial’s timing when there was a pause or suspension of sling mesh use in the United Kingdom beginning in 2018.

Study limitations include the loss to follow-up with diminished response rate of 87.1% at 15 months and 81.4% at 36 months and the inability to adequately assess for the uncommon outcomes, such as mesh-related complications and groin pain.

Further analysis needed

The high rate of dyspareunia (11.7%) with mini-slings deserves further analysis and consideration of whether or not to implant them in patients who are sexually active. Groin or thigh pain did not differ at 36 months but reported pain coincided with the higher percentage of transobturator slings placed over retropubic slings. Prior randomized trials of transobturator versus retropubic midurethral slings have demonstrated this same phenomenon of increased groin pain with the transobturator approach.² Furthermore, this study by Abdel-Fattah and colleagues excluded patients with advanced anterior or apical prolapse, but one trial is currently underway in the United States.⁴

In conclusion, this trial suggests some advantages of single-incision mini-slings—ability to perform the procedure under local anesthesia, less synthetic mesh implantation with theoretically decreased risk of bladder perforation or bowel injury, and potential for easier removal compared with full-length slings. Disadvantages include dyspareunia and mesh exposure, which could be significant trade-offs for patients. ●

Abdel-Fattah M, Cooper D, Davidson T, et al. Single-incision mini-slings for stress urinary incontinence in women. N Engl J Med. 2022;386:1230-1243.

EXPERT COMMENTARY

A joint society position statement by the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction published in December 2021 declared synthetic midurethral slings, first cleared for use in the United States in the early 1990s, the most extensively studied anti-incontinence operation and the standard of care for the treatment of female stress urinary incontinence.¹ Full-length retropubic and transobturator (out-in and in-out) slings have been extensively evaluated for safety and efficacy in well-conducted randomized trials.² Single-incision mini-slings (SIMS) were first cleared for use in 2006, but they lack the long-term safety and comparative effectiveness data of full-length standard midurethral slings (SMUS).³ Furthermore, several iterations of the mini-slings have come to market but have been withdrawn or modified to allow for adjustability.

The SIMS trial by Abdel-Fattah and colleagues, published recently in the New England Journal of Medicine, is one of the few randomized trials with long-term (3 year) subjective and objective outcome data based on comparison of adjustable single-incision mini-slings versus standard full-length midurethral slings.

Details of the study

The SIMS trial is a noninferiority multicenter randomized controlled trial funded by the National Institute for Health Research at 21 hospitals in the United Kingdom that compared adjustable mini-sling procedures performed under local anesthesia with full-length retrotropubic and transobturator sling procedures performed under general anesthesia. Patients and surgeons were not masked to study group assignment because of the differences in anesthesia, and patients with greater than stage 2 prolapse were excluded from the trial.

The primary outcome was Patient Global Impression of Improvement (PGI-I) based on a 7-point Likert scale, with success defined as very much improved or much improved at 15 months and failure defined as all other responses (improved, same, worse, much worse, and very much worse). A noninferiority margin was set at 10 percentage points at 15 months.

Secondary outcomes and adverse events at 36 months included postoperative pain, return to normal activities, objective success based on a 24-hour pad test weight of less than 8 g, and tape exposure, organ injury, new or worsening urinary urgency, dyspareunia, and need for prolonged catheterization.

A total of 596 women were enrolled in the study, 298 in the mini-sling arm and 298 in the standard midurethral sling arm. Baseline characteristics were similar in both groups with most sling procedures being performed by general consultant gynecologists (>60%) versus subspecialist urogynecologists.

Results. Success at 15 months, based on the PGI-I responses of very much better or much better, was noted in 79.1% of patients in the mini-sling group (212/268) versus 75.6% in the full-length sling group (189/250). The authors deemed mini-slings noninferior to standard full-length slings (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<.001 for noninferiority). Success rates declined but remained similar in both groups at 36 months: 72% in the mini-sling group (177/246) and 66.8% (157/235) in the full-length sling group.

More than 70% of mini-incision slings were Altis (Coloplast) and 22% were Ajust (CR Bard; since withdrawn from the market). The majority of standard midurethral full-length slings were transobturator slings (52.9%) versus retropubic slings (35.6%).

While blood loss, organ injury, and 36-month objective 24-hour pad test did not differ between groups, there were significant differences in other secondary outcomes. Dyspareunia and coital incontinence were more common with mini-slings at 15 and 36 months, reported in 11.7% of the mini-sling group and 4.8% of the full-length group (P<.01). Groin or thigh pain did not differ significantly between groups at 36 months (14.1% in mini-sling and 14.9% in full-length sling group, P = .61). Mesh exposure was noted in 3.3% of those with mini-slings and 1.9% of those with standard midurethral slings. The need for surgical intervention to treat recurrent stress incontinence or mesh removal for voiding dysfunction, pain, or mesh exposure also did not differ between groups (8.7% of the mini-sling group and 4.6% of the midurethral sling group; P = .12).

Study strengths and limitations

The strengths of this pragmatic randomized trial are in the use of clinically important and validated patient-reported subjective and objective outcomes in an adequately powered multisite trial of long duration (36 months). This study is important in demonstrating noninferiority of the mini-sling procedure compared with full-length slings, especially given this trial’s timing when there was a pause or suspension of sling mesh use in the United Kingdom beginning in 2018.

Study limitations include the loss to follow-up with diminished response rate of 87.1% at 15 months and 81.4% at 36 months and the inability to adequately assess for the uncommon outcomes, such as mesh-related complications and groin pain.

Further analysis needed

The high rate of dyspareunia (11.7%) with mini-slings deserves further analysis and consideration of whether or not to implant them in patients who are sexually active. Groin or thigh pain did not differ at 36 months but reported pain coincided with the higher percentage of transobturator slings placed over retropubic slings. Prior randomized trials of transobturator versus retropubic midurethral slings have demonstrated this same phenomenon of increased groin pain with the transobturator approach.² Furthermore, this study by Abdel-Fattah and colleagues excluded patients with advanced anterior or apical prolapse, but one trial is currently underway in the United States.⁴

In conclusion, this trial suggests some advantages of single-incision mini-slings—ability to perform the procedure under local anesthesia, less synthetic mesh implantation with theoretically decreased risk of bladder perforation or bowel injury, and potential for easier removal compared with full-length slings. Disadvantages include dyspareunia and mesh exposure, which could be significant trade-offs for patients. ●

Tita AT, Szychowski JM, Boggess K, et al. Treatment for mild chronic hypertension during pregnancy. N Engl J Med. 2022;386:1781-1792. doi: 10.1056/NEJMoa2201295.

Expert Commentary

In the nonpregnant population, medical management of hypertension >140/90 mm Hg is standard practice. By contrast, much higher blood pressures (BPs; up to 160/110 mm Hg) traditionally have been tolerated in pregnant patients with chronic hypertension without initiating treatment, and existing medications are often discontinued during pregnancy. Concern for impaired fetal growth as well as lack of data on improved outcomes have led to different recommendations for the management of mild chronic hypertension in pregnancy. However, chronic hypertension affects a substantial number of pregnant patients and is known to be a risk factor for severe short-term pregnancy and long-term health complications. With preliminary data suggesting that BPs >140/90 mm Hg prior to 20 weeks’ gestation are associated with an increase in adverse outcomes, Tita and colleagues sought to determine the effects of decreasing BP in pregnant patients with mild chronic hypertension.

Details about the study

This is an investigator-initiated, multicenter, pragmatic, open-label, randomized control trial of 2,408 patients with mild chronic hypertension. The active treatment group was treated with antihypertensive medication (including titration of existing medication), targeting a BP of <140/90 mm Hg. The control group only received medication for severe hypertension (≥160 mm Hg systolic or ≥105 mm Hg diastolic). The primary outcome of the study was a composite of preeclampsia with severe features, medically indicated preterm delivery prior to 35 weeks’ gestation (not spontaneous labor or rupture of membranes), placental abruption, and fetal or neonatal death. Birthweight that was less than the 10th percentile was used as a safety outcome. The hypothesis was that treatment would decrease the rate of adverse pregnancy and fetal/neonatal outcomes.

The patient population of singleton pregnancies at a gestational age of less than 23 weeks included 56% with known chronic hypertension on medications, 22% with known chronic hypertension without medications, and 22% with newly diagnosed (during pregnancy) chronic hypertension. The treatment group primarily received labetalol (61.7%) or nifedipine (35.6%); the maximum dose of a single agent was used as tolerated prior to adding a second agent. The control group only received an antihypertensive medication for severe hypertension.

Treatment of chronic hypertension demonstrated a decreased risk of the composite adverse outcome with an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<.001) and a number needed to treat (NNT) of 14.7. When analyzed separately, a similar risk reduction was noted for both preeclampsia with severe features and medically indicated preterm birth <35 weeks’ gestation. There was no statistical difference between the groups for birth weight <10th percentile and <5th percentile (adjusted risk ratio, 1.04 [0.82–1.31] vs 0.89 [0.62–1.26], respectively).

Planned subgroup analysis by type of chronic hypertension, race/ethnic group, diabetes status, gestational age at baseline, and body mass index (BMI) demonstrated a similar treatment effect to the overall composite primary outcome, with the exception of patients with newly diagnosed chronic hypertension or BMI ≥40 kg/m². Overall maternal and neonatal composite outcomes of severe complications did not differ between treatment and control groups; however, rates of severe preeclampsia, any preeclampsia, preterm birth rate, and birthweight <2,500 g were all lower in the treatment group.

Study strengths and weaknesses

The study strengths cited are a large sample size, multiple study sites, an independent data and safety monitoring board with close oversight, and centralized blinded confirmation of outcomes. Another strength is that the patient population of the study was similar to the overall population of pregnant patients in the United States with chronic hypertension in terms of age, race, and ethnicity.

The weaknesses of the study include the open-label design and the high ratio of screened to enrolled patients. Both of these issues appear related to the study design (ethics and logistics of a blinded treatment and gestational age cutoff) and the physiology of pregnancy (expected decrease in BP in the second trimester rendering patients ineligible due to lower BP). The study was also not powered to assess treatment effect in all of the subgroups, and further evaluation of patients with newly diagnosed chronic hypertension and BMI ≥ 40 kg/m² is needed. ●

Tita AT, Szychowski JM, Boggess K, et al. Treatment for mild chronic hypertension during pregnancy. N Engl J Med. 2022;386:1781-1792. doi: 10.1056/NEJMoa2201295.

Expert Commentary

In the nonpregnant population, medical management of hypertension >140/90 mm Hg is standard practice. By contrast, much higher blood pressures (BPs; up to 160/110 mm Hg) traditionally have been tolerated in pregnant patients with chronic hypertension without initiating treatment, and existing medications are often discontinued during pregnancy. Concern for impaired fetal growth as well as lack of data on improved outcomes have led to different recommendations for the management of mild chronic hypertension in pregnancy. However, chronic hypertension affects a substantial number of pregnant patients and is known to be a risk factor for severe short-term pregnancy and long-term health complications. With preliminary data suggesting that BPs >140/90 mm Hg prior to 20 weeks’ gestation are associated with an increase in adverse outcomes, Tita and colleagues sought to determine the effects of decreasing BP in pregnant patients with mild chronic hypertension.

Details about the study

This is an investigator-initiated, multicenter, pragmatic, open-label, randomized control trial of 2,408 patients with mild chronic hypertension. The active treatment group was treated with antihypertensive medication (including titration of existing medication), targeting a BP of <140/90 mm Hg. The control group only received medication for severe hypertension (≥160 mm Hg systolic or ≥105 mm Hg diastolic). The primary outcome of the study was a composite of preeclampsia with severe features, medically indicated preterm delivery prior to 35 weeks’ gestation (not spontaneous labor or rupture of membranes), placental abruption, and fetal or neonatal death. Birthweight that was less than the 10th percentile was used as a safety outcome. The hypothesis was that treatment would decrease the rate of adverse pregnancy and fetal/neonatal outcomes.

The patient population of singleton pregnancies at a gestational age of less than 23 weeks included 56% with known chronic hypertension on medications, 22% with known chronic hypertension without medications, and 22% with newly diagnosed (during pregnancy) chronic hypertension. The treatment group primarily received labetalol (61.7%) or nifedipine (35.6%); the maximum dose of a single agent was used as tolerated prior to adding a second agent. The control group only received an antihypertensive medication for severe hypertension.

Treatment of chronic hypertension demonstrated a decreased risk of the composite adverse outcome with an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<.001) and a number needed to treat (NNT) of 14.7. When analyzed separately, a similar risk reduction was noted for both preeclampsia with severe features and medically indicated preterm birth <35 weeks’ gestation. There was no statistical difference between the groups for birth weight <10th percentile and <5th percentile (adjusted risk ratio, 1.04 [0.82–1.31] vs 0.89 [0.62–1.26], respectively).

Planned subgroup analysis by type of chronic hypertension, race/ethnic group, diabetes status, gestational age at baseline, and body mass index (BMI) demonstrated a similar treatment effect to the overall composite primary outcome, with the exception of patients with newly diagnosed chronic hypertension or BMI ≥40 kg/m². Overall maternal and neonatal composite outcomes of severe complications did not differ between treatment and control groups; however, rates of severe preeclampsia, any preeclampsia, preterm birth rate, and birthweight <2,500 g were all lower in the treatment group.

Study strengths and weaknesses

The study strengths cited are a large sample size, multiple study sites, an independent data and safety monitoring board with close oversight, and centralized blinded confirmation of outcomes. Another strength is that the patient population of the study was similar to the overall population of pregnant patients in the United States with chronic hypertension in terms of age, race, and ethnicity.

The weaknesses of the study include the open-label design and the high ratio of screened to enrolled patients. Both of these issues appear related to the study design (ethics and logistics of a blinded treatment and gestational age cutoff) and the physiology of pregnancy (expected decrease in BP in the second trimester rendering patients ineligible due to lower BP). The study was also not powered to assess treatment effect in all of the subgroups, and further evaluation of patients with newly diagnosed chronic hypertension and BMI ≥ 40 kg/m² is needed. ●

Tita AT, Szychowski JM, Boggess K, et al. Treatment for mild chronic hypertension during pregnancy. N Engl J Med. 2022;386:1781-1792. doi: 10.1056/NEJMoa2201295.

Expert Commentary

In the nonpregnant population, medical management of hypertension >140/90 mm Hg is standard practice. By contrast, much higher blood pressures (BPs; up to 160/110 mm Hg) traditionally have been tolerated in pregnant patients with chronic hypertension without initiating treatment, and existing medications are often discontinued during pregnancy. Concern for impaired fetal growth as well as lack of data on improved outcomes have led to different recommendations for the management of mild chronic hypertension in pregnancy. However, chronic hypertension affects a substantial number of pregnant patients and is known to be a risk factor for severe short-term pregnancy and long-term health complications. With preliminary data suggesting that BPs >140/90 mm Hg prior to 20 weeks’ gestation are associated with an increase in adverse outcomes, Tita and colleagues sought to determine the effects of decreasing BP in pregnant patients with mild chronic hypertension.

Details about the study

This is an investigator-initiated, multicenter, pragmatic, open-label, randomized control trial of 2,408 patients with mild chronic hypertension. The active treatment group was treated with antihypertensive medication (including titration of existing medication), targeting a BP of <140/90 mm Hg. The control group only received medication for severe hypertension (≥160 mm Hg systolic or ≥105 mm Hg diastolic). The primary outcome of the study was a composite of preeclampsia with severe features, medically indicated preterm delivery prior to 35 weeks’ gestation (not spontaneous labor or rupture of membranes), placental abruption, and fetal or neonatal death. Birthweight that was less than the 10th percentile was used as a safety outcome. The hypothesis was that treatment would decrease the rate of adverse pregnancy and fetal/neonatal outcomes.

The patient population of singleton pregnancies at a gestational age of less than 23 weeks included 56% with known chronic hypertension on medications, 22% with known chronic hypertension without medications, and 22% with newly diagnosed (during pregnancy) chronic hypertension. The treatment group primarily received labetalol (61.7%) or nifedipine (35.6%); the maximum dose of a single agent was used as tolerated prior to adding a second agent. The control group only received an antihypertensive medication for severe hypertension.

Treatment of chronic hypertension demonstrated a decreased risk of the composite adverse outcome with an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<.001) and a number needed to treat (NNT) of 14.7. When analyzed separately, a similar risk reduction was noted for both preeclampsia with severe features and medically indicated preterm birth <35 weeks’ gestation. There was no statistical difference between the groups for birth weight <10th percentile and <5th percentile (adjusted risk ratio, 1.04 [0.82–1.31] vs 0.89 [0.62–1.26], respectively).

Planned subgroup analysis by type of chronic hypertension, race/ethnic group, diabetes status, gestational age at baseline, and body mass index (BMI) demonstrated a similar treatment effect to the overall composite primary outcome, with the exception of patients with newly diagnosed chronic hypertension or BMI ≥40 kg/m². Overall maternal and neonatal composite outcomes of severe complications did not differ between treatment and control groups; however, rates of severe preeclampsia, any preeclampsia, preterm birth rate, and birthweight <2,500 g were all lower in the treatment group.

Study strengths and weaknesses

The study strengths cited are a large sample size, multiple study sites, an independent data and safety monitoring board with close oversight, and centralized blinded confirmation of outcomes. Another strength is that the patient population of the study was similar to the overall population of pregnant patients in the United States with chronic hypertension in terms of age, race, and ethnicity.

The weaknesses of the study include the open-label design and the high ratio of screened to enrolled patients. Both of these issues appear related to the study design (ethics and logistics of a blinded treatment and gestational age cutoff) and the physiology of pregnancy (expected decrease in BP in the second trimester rendering patients ineligible due to lower BP). The study was also not powered to assess treatment effect in all of the subgroups, and further evaluation of patients with newly diagnosed chronic hypertension and BMI ≥ 40 kg/m² is needed. ●