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WASHINGTON – The initiation of 17P after the recommended 16-21 weeks’ gestation period appears to be beneficial, whereas stopping the drug early may increase a patient’s risk of spontaneous preterm delivery, according to a study of more than 700 women on Medicaid.
There were no significant differences in rates of recurrent spontaneous preterm birth (SPTB) at less than 37, 35, or 32 weeks’ gestation, regardless of whether 17P was started before or after 21 weeks’ gestation. "However, if you look at outcomes of those patients who discontinued early, there is statistically significant difference in each gestational age band in those patients who completed the therapy vs. those who discontinued early," Dr. Brad Lucas said at the annual meeting of the American College of Obstetricians and Gynecologists.
Level I evidence suggests that 17P – a form of progesterone called 17 alphahydroxyprogesterone caproate – is effective in preventing recurrent preterm birth in patients with a prior history of spontaneous preterm delivery. In fact, ACOG recommends progesterone supplementation for the prevention of recurrent preterm birth in patients with current singleton gestation and a prior history of SPTD at less than 37 weeks’ gestation (ACOG Committee Opinion No. 419, 2008). However, compliance issues and social barriers to treatment with 17P are common in the Medicaid population, noted Dr. Lucas, an ob.gyn. employed at Centene Corp., a health management and services company that provides health plans in 11 states.
The Food and Drug Administration approved Makena (a noncompounded form of 17P) earlier this year for the prevention of recurrent preterm birth in women with singleton pregnancies. Makena is marketed by Ther-Rx, a subsidiary of Missouri-based KV Pharmaceutical Co. However, Makenas high price is raising physicians’ ire.
A compounded form of 17P was used in this study.
The investigators performed a retrospective study of data that was prospectively collected between July 2004 and May 2010. They included women with a current singleton pregnancy and a history of one or more prior SPTB (20 to less than 37 weeks’ gestation). These women could have no current or planned cerclage.
"We use the treatment guidelines that are commonly associated with those in the Meis study," he said (N. Engl. J. Med. 2003;348:2379-85). Weekly 17P injections (250 mg on days 6-9) were initiated starting at 16 weeks up to 21 weeks’ gestation. The injections were discontinued at 36 weeks or at preterm delivery.
A total of 790 women with prior SPTB received care through a managed Medicaid health plan. These women were enrolled in a 17P home-administration program for the prevention of recurrent preterm birth, in which a nurse administered a weekly IM injection of compounded 17P (250 mg) to women in their homes. Written and verbal education was also provided by the perinatal nurse. Intensive case management was provided. Patients had round-the-clock telephone access to nurses, who could answer questions or concerns.
The primary outcome in this study was adherence to treatment guidelines (initiation of treatment at 16 to less than 21 weeks vs. initiation at 21 weeks or more). Patients also had to complete the recommended treatment – continuation until within 10 days of 36 weeks’ gestation or until preterm delivery.
The average maternal age was 28 years. Only a small percentage of the patients were teens (3.5%) or were older than 34 years (6%). Interestingly, 36% had had more than one prior preterm delivery.
In terms of adherence to the guidelines, the average gestational age at the start of 17P injections was 21 weeks. More than half of the women (59%) started treatment at 16-21 weeks’ gestation. The average number of injections received was 13. Only seven women refused treatment after the first injection. Most women (89%) received all expected injections.
The average gestational age at delivery was 37 weeks. In all, 28% of women had SPTB prior to 37 weeks, 12% had SPTB prior to 35 weeks, and 6% had SPTB prior to 32 weeks. More than a third of women (36%) had cesarean delivery. Some 15% of infants required care in neonatal ICUs or special-care nurseries. Perinatal loss was less than 1%. Overall, 35% of women delivered before 37 weeks’ gestation and 65% delivered at 37 weeks’ gestation or later.
In terms of early discontinuation of 17P, 38% of mothers who discontinued 17P use early had SPTB at less than 37 weeks’ gestation, compared with only 26% of women who did not discontinue 17P. Likewise, 23% of mothers who discontinued 17P use early had SPTB at less than 35 weeks, compared with only 10% of women who did not discontinue; 12% of mothers who discontinued 17P use early had SPTB at less than 32 weeks, compared with only 4% of women who did not discontinue. All of the differences were significant.
"Early discontinuation of 17P increases a patient’s risk for recurrent spontaneous preterm delivery," said Dr. Lucas.
Dr. Lucas is an employee of Centene Corp. His coauthor, Dr. Gary J. Stanziano, is an employee of Alere, which provides home medical services. However, no funding was received from either company for the completion of this study.
WASHINGTON – The initiation of 17P after the recommended 16-21 weeks’ gestation period appears to be beneficial, whereas stopping the drug early may increase a patient’s risk of spontaneous preterm delivery, according to a study of more than 700 women on Medicaid.
There were no significant differences in rates of recurrent spontaneous preterm birth (SPTB) at less than 37, 35, or 32 weeks’ gestation, regardless of whether 17P was started before or after 21 weeks’ gestation. "However, if you look at outcomes of those patients who discontinued early, there is statistically significant difference in each gestational age band in those patients who completed the therapy vs. those who discontinued early," Dr. Brad Lucas said at the annual meeting of the American College of Obstetricians and Gynecologists.
Level I evidence suggests that 17P – a form of progesterone called 17 alphahydroxyprogesterone caproate – is effective in preventing recurrent preterm birth in patients with a prior history of spontaneous preterm delivery. In fact, ACOG recommends progesterone supplementation for the prevention of recurrent preterm birth in patients with current singleton gestation and a prior history of SPTD at less than 37 weeks’ gestation (ACOG Committee Opinion No. 419, 2008). However, compliance issues and social barriers to treatment with 17P are common in the Medicaid population, noted Dr. Lucas, an ob.gyn. employed at Centene Corp., a health management and services company that provides health plans in 11 states.
The Food and Drug Administration approved Makena (a noncompounded form of 17P) earlier this year for the prevention of recurrent preterm birth in women with singleton pregnancies. Makena is marketed by Ther-Rx, a subsidiary of Missouri-based KV Pharmaceutical Co. However, Makenas high price is raising physicians’ ire.
A compounded form of 17P was used in this study.
The investigators performed a retrospective study of data that was prospectively collected between July 2004 and May 2010. They included women with a current singleton pregnancy and a history of one or more prior SPTB (20 to less than 37 weeks’ gestation). These women could have no current or planned cerclage.
"We use the treatment guidelines that are commonly associated with those in the Meis study," he said (N. Engl. J. Med. 2003;348:2379-85). Weekly 17P injections (250 mg on days 6-9) were initiated starting at 16 weeks up to 21 weeks’ gestation. The injections were discontinued at 36 weeks or at preterm delivery.
A total of 790 women with prior SPTB received care through a managed Medicaid health plan. These women were enrolled in a 17P home-administration program for the prevention of recurrent preterm birth, in which a nurse administered a weekly IM injection of compounded 17P (250 mg) to women in their homes. Written and verbal education was also provided by the perinatal nurse. Intensive case management was provided. Patients had round-the-clock telephone access to nurses, who could answer questions or concerns.
The primary outcome in this study was adherence to treatment guidelines (initiation of treatment at 16 to less than 21 weeks vs. initiation at 21 weeks or more). Patients also had to complete the recommended treatment – continuation until within 10 days of 36 weeks’ gestation or until preterm delivery.
The average maternal age was 28 years. Only a small percentage of the patients were teens (3.5%) or were older than 34 years (6%). Interestingly, 36% had had more than one prior preterm delivery.
In terms of adherence to the guidelines, the average gestational age at the start of 17P injections was 21 weeks. More than half of the women (59%) started treatment at 16-21 weeks’ gestation. The average number of injections received was 13. Only seven women refused treatment after the first injection. Most women (89%) received all expected injections.
The average gestational age at delivery was 37 weeks. In all, 28% of women had SPTB prior to 37 weeks, 12% had SPTB prior to 35 weeks, and 6% had SPTB prior to 32 weeks. More than a third of women (36%) had cesarean delivery. Some 15% of infants required care in neonatal ICUs or special-care nurseries. Perinatal loss was less than 1%. Overall, 35% of women delivered before 37 weeks’ gestation and 65% delivered at 37 weeks’ gestation or later.
In terms of early discontinuation of 17P, 38% of mothers who discontinued 17P use early had SPTB at less than 37 weeks’ gestation, compared with only 26% of women who did not discontinue 17P. Likewise, 23% of mothers who discontinued 17P use early had SPTB at less than 35 weeks, compared with only 10% of women who did not discontinue; 12% of mothers who discontinued 17P use early had SPTB at less than 32 weeks, compared with only 4% of women who did not discontinue. All of the differences were significant.
"Early discontinuation of 17P increases a patient’s risk for recurrent spontaneous preterm delivery," said Dr. Lucas.
Dr. Lucas is an employee of Centene Corp. His coauthor, Dr. Gary J. Stanziano, is an employee of Alere, which provides home medical services. However, no funding was received from either company for the completion of this study.
WASHINGTON – The initiation of 17P after the recommended 16-21 weeks’ gestation period appears to be beneficial, whereas stopping the drug early may increase a patient’s risk of spontaneous preterm delivery, according to a study of more than 700 women on Medicaid.
There were no significant differences in rates of recurrent spontaneous preterm birth (SPTB) at less than 37, 35, or 32 weeks’ gestation, regardless of whether 17P was started before or after 21 weeks’ gestation. "However, if you look at outcomes of those patients who discontinued early, there is statistically significant difference in each gestational age band in those patients who completed the therapy vs. those who discontinued early," Dr. Brad Lucas said at the annual meeting of the American College of Obstetricians and Gynecologists.
Level I evidence suggests that 17P – a form of progesterone called 17 alphahydroxyprogesterone caproate – is effective in preventing recurrent preterm birth in patients with a prior history of spontaneous preterm delivery. In fact, ACOG recommends progesterone supplementation for the prevention of recurrent preterm birth in patients with current singleton gestation and a prior history of SPTD at less than 37 weeks’ gestation (ACOG Committee Opinion No. 419, 2008). However, compliance issues and social barriers to treatment with 17P are common in the Medicaid population, noted Dr. Lucas, an ob.gyn. employed at Centene Corp., a health management and services company that provides health plans in 11 states.
The Food and Drug Administration approved Makena (a noncompounded form of 17P) earlier this year for the prevention of recurrent preterm birth in women with singleton pregnancies. Makena is marketed by Ther-Rx, a subsidiary of Missouri-based KV Pharmaceutical Co. However, Makenas high price is raising physicians’ ire.
A compounded form of 17P was used in this study.
The investigators performed a retrospective study of data that was prospectively collected between July 2004 and May 2010. They included women with a current singleton pregnancy and a history of one or more prior SPTB (20 to less than 37 weeks’ gestation). These women could have no current or planned cerclage.
"We use the treatment guidelines that are commonly associated with those in the Meis study," he said (N. Engl. J. Med. 2003;348:2379-85). Weekly 17P injections (250 mg on days 6-9) were initiated starting at 16 weeks up to 21 weeks’ gestation. The injections were discontinued at 36 weeks or at preterm delivery.
A total of 790 women with prior SPTB received care through a managed Medicaid health plan. These women were enrolled in a 17P home-administration program for the prevention of recurrent preterm birth, in which a nurse administered a weekly IM injection of compounded 17P (250 mg) to women in their homes. Written and verbal education was also provided by the perinatal nurse. Intensive case management was provided. Patients had round-the-clock telephone access to nurses, who could answer questions or concerns.
The primary outcome in this study was adherence to treatment guidelines (initiation of treatment at 16 to less than 21 weeks vs. initiation at 21 weeks or more). Patients also had to complete the recommended treatment – continuation until within 10 days of 36 weeks’ gestation or until preterm delivery.
The average maternal age was 28 years. Only a small percentage of the patients were teens (3.5%) or were older than 34 years (6%). Interestingly, 36% had had more than one prior preterm delivery.
In terms of adherence to the guidelines, the average gestational age at the start of 17P injections was 21 weeks. More than half of the women (59%) started treatment at 16-21 weeks’ gestation. The average number of injections received was 13. Only seven women refused treatment after the first injection. Most women (89%) received all expected injections.
The average gestational age at delivery was 37 weeks. In all, 28% of women had SPTB prior to 37 weeks, 12% had SPTB prior to 35 weeks, and 6% had SPTB prior to 32 weeks. More than a third of women (36%) had cesarean delivery. Some 15% of infants required care in neonatal ICUs or special-care nurseries. Perinatal loss was less than 1%. Overall, 35% of women delivered before 37 weeks’ gestation and 65% delivered at 37 weeks’ gestation or later.
In terms of early discontinuation of 17P, 38% of mothers who discontinued 17P use early had SPTB at less than 37 weeks’ gestation, compared with only 26% of women who did not discontinue 17P. Likewise, 23% of mothers who discontinued 17P use early had SPTB at less than 35 weeks, compared with only 10% of women who did not discontinue; 12% of mothers who discontinued 17P use early had SPTB at less than 32 weeks, compared with only 4% of women who did not discontinue. All of the differences were significant.
"Early discontinuation of 17P increases a patient’s risk for recurrent spontaneous preterm delivery," said Dr. Lucas.
Dr. Lucas is an employee of Centene Corp. His coauthor, Dr. Gary J. Stanziano, is an employee of Alere, which provides home medical services. However, no funding was received from either company for the completion of this study.
FROM THE ANNUAL MEETING OF THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS
Major Finding: Starting 17P injections after 21 weeks’ gestation helps prevent spontaneous preterm births, but stopping the drug early significantly increases the risk of spontaneous preterm birth.
Data Source: A retrospective study of 790 women on Medicaid.
Disclosures: Dr. Lucas is an employee of Centene Corp., a health management and services company that provides health plans in 11 states. His coauthor, Dr. Gary J. Stanziano, is an employee of Alere, which provides home medical services. However, no funding was received from either company for the completion of this study.
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