MDedge ObGyn

Key clinical point: Successful implementation of immediate postpartum LARC was associated with clinical implementation champions, often supported by an interdisciplinary team, and favorable payer reimbursement policies.

Major finding: On average, maternity hospitals used 18 suggested strategies to implement immediate postpartum long-active reversible contraception (LARC) services.

Study details: The data come from a case study of 11 maternity hospitals and included semi-structured interviews with 78 clinicians, nurses, residents, pharmacy and revenue cycle staff, and hospital administrators.

Disclosures: Lead author Dr. Moniz was supported by the Agency for Healthcare Research and Quality (AHRQ); coauthors were supported by the National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases.

Source: Moniz MH et al. Implement Sci Commun. 2021 Apr 12. doi: 10.1186/s43058-021-00136-7.

Key clinical point: Successful implementation of immediate postpartum LARC was associated with clinical implementation champions, often supported by an interdisciplinary team, and favorable payer reimbursement policies.

Major finding: On average, maternity hospitals used 18 suggested strategies to implement immediate postpartum long-active reversible contraception (LARC) services.

Study details: The data come from a case study of 11 maternity hospitals and included semi-structured interviews with 78 clinicians, nurses, residents, pharmacy and revenue cycle staff, and hospital administrators.

Disclosures: Lead author Dr. Moniz was supported by the Agency for Healthcare Research and Quality (AHRQ); coauthors were supported by the National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases.

Source: Moniz MH et al. Implement Sci Commun. 2021 Apr 12. doi: 10.1186/s43058-021-00136-7.

Key clinical point: Successful implementation of immediate postpartum LARC was associated with clinical implementation champions, often supported by an interdisciplinary team, and favorable payer reimbursement policies.

Major finding: On average, maternity hospitals used 18 suggested strategies to implement immediate postpartum long-active reversible contraception (LARC) services.

Study details: The data come from a case study of 11 maternity hospitals and included semi-structured interviews with 78 clinicians, nurses, residents, pharmacy and revenue cycle staff, and hospital administrators.

Disclosures: Lead author Dr. Moniz was supported by the Agency for Healthcare Research and Quality (AHRQ); coauthors were supported by the National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases.

Source: Moniz MH et al. Implement Sci Commun. 2021 Apr 12. doi: 10.1186/s43058-021-00136-7.

Key clinical point: African American males aged 14-15 years were more likely than 18- to 19- year-old males to use a condom the last time they had sex.

Major finding: Increased condom use was associated with personal factors including high positive attachment to the boyfriend/girlfriend as was a greater number of sexual partners, younger age at first sexual encounter, and knowledge that the individual had a sexually-transmitted infection in the past year.

Study details: The data come from the Mobile Youth Survey, a community-based survey of adolescents in Mobile, Alabama, between 1998 and 2011; the study population included 3,718 individuals.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chambliss JT et al. Am J Mens Health. 2021 Apr 15. doi: 10.1177/15579883211009039.

Key clinical point: African American males aged 14-15 years were more likely than 18- to 19- year-old males to use a condom the last time they had sex.

Major finding: Increased condom use was associated with personal factors including high positive attachment to the boyfriend/girlfriend as was a greater number of sexual partners, younger age at first sexual encounter, and knowledge that the individual had a sexually-transmitted infection in the past year.

Study details: The data come from the Mobile Youth Survey, a community-based survey of adolescents in Mobile, Alabama, between 1998 and 2011; the study population included 3,718 individuals.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chambliss JT et al. Am J Mens Health. 2021 Apr 15. doi: 10.1177/15579883211009039.

Key clinical point: African American males aged 14-15 years were more likely than 18- to 19- year-old males to use a condom the last time they had sex.

Major finding: Increased condom use was associated with personal factors including high positive attachment to the boyfriend/girlfriend as was a greater number of sexual partners, younger age at first sexual encounter, and knowledge that the individual had a sexually-transmitted infection in the past year.

Study details: The data come from the Mobile Youth Survey, a community-based survey of adolescents in Mobile, Alabama, between 1998 and 2011; the study population included 3,718 individuals.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chambliss JT et al. Am J Mens Health. 2021 Apr 15. doi: 10.1177/15579883211009039.

Key clinical point: Immediate postpartum insertion of copper intrauterine devices is effective and acceptable for women living in low- and middle-income countries.

Major finding: The six-month continuation rate for immediate postpartum copper IUDs was 87% in low- and middle-income countries; pooled estimated rates of adverse outcomes at six months were 6% for expulsion, 5% for removal, and 0.2% for infection.

Study details: The data come from a meta-analysis of 11 studies of the use and continuation of postpartum long-acting reversible contraception in low- and middle-income countries, including 2 randomized, controlled trials and 9 prospective cohort studies.

Disclosures: The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Doris Duke Charitable Foundation. The researchers had no financial conflicts to disclose.

Source: Marchin A et al. J Womens Health Dev. 2021 Mar 18. doi: 10.26502/fjwhd.2644-28840059. 

Key clinical point: Immediate postpartum insertion of copper intrauterine devices is effective and acceptable for women living in low- and middle-income countries.

Major finding: The six-month continuation rate for immediate postpartum copper IUDs was 87% in low- and middle-income countries; pooled estimated rates of adverse outcomes at six months were 6% for expulsion, 5% for removal, and 0.2% for infection.

Study details: The data come from a meta-analysis of 11 studies of the use and continuation of postpartum long-acting reversible contraception in low- and middle-income countries, including 2 randomized, controlled trials and 9 prospective cohort studies.

Disclosures: The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Doris Duke Charitable Foundation. The researchers had no financial conflicts to disclose.

Source: Marchin A et al. J Womens Health Dev. 2021 Mar 18. doi: 10.26502/fjwhd.2644-28840059. 

Key clinical point: Immediate postpartum insertion of copper intrauterine devices is effective and acceptable for women living in low- and middle-income countries.

Major finding: The six-month continuation rate for immediate postpartum copper IUDs was 87% in low- and middle-income countries; pooled estimated rates of adverse outcomes at six months were 6% for expulsion, 5% for removal, and 0.2% for infection.

Study details: The data come from a meta-analysis of 11 studies of the use and continuation of postpartum long-acting reversible contraception in low- and middle-income countries, including 2 randomized, controlled trials and 9 prospective cohort studies.

Disclosures: The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Doris Duke Charitable Foundation. The researchers had no financial conflicts to disclose.

Source: Marchin A et al. J Womens Health Dev. 2021 Mar 18. doi: 10.26502/fjwhd.2644-28840059. 

Key clinical point: Women taking oral contraceptives showed lower volume in the hypothalamic and pituitary gland compared to normally cycling women based on magnetic resonance imaging (MRI) data.

Major finding: Hypothalamic and pituitary volumes were significantly lower in women using oral contraceptives compared to naturally cycling women (B = -81.2 for both; P = 0.002 and P = -0.04, respectively).

Study details: The data come from a prospective study of 50 healthy women aged 18 and older, including 21 oral contraceptive users, and 29 naturally cycling women.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chen KX et al. PLos One. 2021 Apr 21.  doi: 10.1371/journal.pone.0249482. eCollection 2021.

Key clinical point: Women taking oral contraceptives showed lower volume in the hypothalamic and pituitary gland compared to normally cycling women based on magnetic resonance imaging (MRI) data.

Major finding: Hypothalamic and pituitary volumes were significantly lower in women using oral contraceptives compared to naturally cycling women (B = -81.2 for both; P = 0.002 and P = -0.04, respectively).

Study details: The data come from a prospective study of 50 healthy women aged 18 and older, including 21 oral contraceptive users, and 29 naturally cycling women.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chen KX et al. PLos One. 2021 Apr 21.  doi: 10.1371/journal.pone.0249482. eCollection 2021.

Key clinical point: Women taking oral contraceptives showed lower volume in the hypothalamic and pituitary gland compared to normally cycling women based on magnetic resonance imaging (MRI) data.

Major finding: Hypothalamic and pituitary volumes were significantly lower in women using oral contraceptives compared to naturally cycling women (B = -81.2 for both; P = 0.002 and P = -0.04, respectively).

Study details: The data come from a prospective study of 50 healthy women aged 18 and older, including 21 oral contraceptive users, and 29 naturally cycling women.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chen KX et al. PLos One. 2021 Apr 21.  doi: 10.1371/journal.pone.0249482. eCollection 2021.

Key clinical point: Women’s attitudes towards contraceptives affect their willingness to accept a novel HIV prevention product in the form of a vaginal ring; pre-emptive counseling to address women’s concerns may encourage acceptance.

Major finding: Women surveyed about their experience using a monthly dapivirine vaginal ring reported side effects related to menses, and expressed some concern about the long-term impact of the ring and contraception use on fertility.

Study details: The data come from a subset of 214 women of childbearing age enrolled in the ASPIRE trial at 15 sites in Malawi, South Africa, Uganda, and Zambia who received a monthly dapivirine vaginal ring designed for HIV prevention.

Disclosures: The study was supported by the e National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health. The vaginal rings were supplied by the International Partnership for Microbicides (IPM). The researchers had no financial conflicts to disclose.

Source: Leslie J et al. BMC Womens Health. 2021 Apr 23. doi: 10.1186/s12905-021-01321-5.

Key clinical point: Women’s attitudes towards contraceptives affect their willingness to accept a novel HIV prevention product in the form of a vaginal ring; pre-emptive counseling to address women’s concerns may encourage acceptance.

Major finding: Women surveyed about their experience using a monthly dapivirine vaginal ring reported side effects related to menses, and expressed some concern about the long-term impact of the ring and contraception use on fertility.

Study details: The data come from a subset of 214 women of childbearing age enrolled in the ASPIRE trial at 15 sites in Malawi, South Africa, Uganda, and Zambia who received a monthly dapivirine vaginal ring designed for HIV prevention.

Disclosures: The study was supported by the e National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health. The vaginal rings were supplied by the International Partnership for Microbicides (IPM). The researchers had no financial conflicts to disclose.

Source: Leslie J et al. BMC Womens Health. 2021 Apr 23. doi: 10.1186/s12905-021-01321-5.

Key clinical point: Women’s attitudes towards contraceptives affect their willingness to accept a novel HIV prevention product in the form of a vaginal ring; pre-emptive counseling to address women’s concerns may encourage acceptance.

Major finding: Women surveyed about their experience using a monthly dapivirine vaginal ring reported side effects related to menses, and expressed some concern about the long-term impact of the ring and contraception use on fertility.

Study details: The data come from a subset of 214 women of childbearing age enrolled in the ASPIRE trial at 15 sites in Malawi, South Africa, Uganda, and Zambia who received a monthly dapivirine vaginal ring designed for HIV prevention.

Disclosures: The study was supported by the e National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health. The vaginal rings were supplied by the International Partnership for Microbicides (IPM). The researchers had no financial conflicts to disclose.

Source: Leslie J et al. BMC Womens Health. 2021 Apr 23. doi: 10.1186/s12905-021-01321-5.

Key clinical point: Women who used progestin-only contraceptives experienced significantly greater weight gain than those using nonhormonal copper intrauterine devices.

Major finding: After 18 months, all treatment groups gained weight, but the average gain in the DMPA-IM group (3.5 kg) was significantly higher compared with both the LNG implant group (2.4 kg) and copper IUD group (1.5 kg).

Study details: The data come from a secondary analysis of women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial and included 7,829 women aged 16-35 years seen at 12 sites in Kenya, South Africa, and Zambia between December 2015 and October 2018. Of these, 2,609 received intramuscular depot medroxyprogesterone acetate (DMPA-IM), 2,613 received a levonorgestrel (LNG) implant, and 2,607 received a copper intrauterine device (IUD).

Disclosures: The study was supported by the Bill & Melinda Gates Foundation, US Agency for International Development (USAID) and the President's Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council, and UNFPA.

Source: Beksinska M et al. EClinicalMedicine. 2021 Apr 6. doi: 0.1016/j.eclinm.2021.100800.

Key clinical point: Women who used progestin-only contraceptives experienced significantly greater weight gain than those using nonhormonal copper intrauterine devices.

Major finding: After 18 months, all treatment groups gained weight, but the average gain in the DMPA-IM group (3.5 kg) was significantly higher compared with both the LNG implant group (2.4 kg) and copper IUD group (1.5 kg).

Study details: The data come from a secondary analysis of women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial and included 7,829 women aged 16-35 years seen at 12 sites in Kenya, South Africa, and Zambia between December 2015 and October 2018. Of these, 2,609 received intramuscular depot medroxyprogesterone acetate (DMPA-IM), 2,613 received a levonorgestrel (LNG) implant, and 2,607 received a copper intrauterine device (IUD).

Disclosures: The study was supported by the Bill & Melinda Gates Foundation, US Agency for International Development (USAID) and the President's Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council, and UNFPA.

Source: Beksinska M et al. EClinicalMedicine. 2021 Apr 6. doi: 0.1016/j.eclinm.2021.100800.

Key clinical point: Women who used progestin-only contraceptives experienced significantly greater weight gain than those using nonhormonal copper intrauterine devices.

Major finding: After 18 months, all treatment groups gained weight, but the average gain in the DMPA-IM group (3.5 kg) was significantly higher compared with both the LNG implant group (2.4 kg) and copper IUD group (1.5 kg).

Study details: The data come from a secondary analysis of women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial and included 7,829 women aged 16-35 years seen at 12 sites in Kenya, South Africa, and Zambia between December 2015 and October 2018. Of these, 2,609 received intramuscular depot medroxyprogesterone acetate (DMPA-IM), 2,613 received a levonorgestrel (LNG) implant, and 2,607 received a copper intrauterine device (IUD).

Disclosures: The study was supported by the Bill & Melinda Gates Foundation, US Agency for International Development (USAID) and the President's Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council, and UNFPA.

Source: Beksinska M et al. EClinicalMedicine. 2021 Apr 6. doi: 0.1016/j.eclinm.2021.100800.

Key clinical point: Hispanic patients with a higher level of English language acculturation were less likely to use birth control and may require a more detailed discussion of the options for family planning.

Major finding: Hispanic women who reported using birth control had significantly lower English language acculturation compared to those who reported no birth control

Study details: The data come from surveys of 225 Hispanic women that combined the number of years lived in the U.S., the Short Acculturation Scale for Hispanics, and questions about family planning behaviors.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chamberlain R et al. Kans J Med. 2021 Apr 19. doi: 10.17161/kjm.vol1414845.

Key clinical point: Hispanic patients with a higher level of English language acculturation were less likely to use birth control and may require a more detailed discussion of the options for family planning.

Major finding: Hispanic women who reported using birth control had significantly lower English language acculturation compared to those who reported no birth control

Study details: The data come from surveys of 225 Hispanic women that combined the number of years lived in the U.S., the Short Acculturation Scale for Hispanics, and questions about family planning behaviors.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chamberlain R et al. Kans J Med. 2021 Apr 19. doi: 10.17161/kjm.vol1414845.

Key clinical point: Hispanic patients with a higher level of English language acculturation were less likely to use birth control and may require a more detailed discussion of the options for family planning.

Major finding: Hispanic women who reported using birth control had significantly lower English language acculturation compared to those who reported no birth control

Study details: The data come from surveys of 225 Hispanic women that combined the number of years lived in the U.S., the Short Acculturation Scale for Hispanics, and questions about family planning behaviors.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Chamberlain R et al. Kans J Med. 2021 Apr 19. doi: 10.17161/kjm.vol1414845.

Immediate postpartum long-acting reversible contraception (LARC) represents a safe and effective contraceptive strategy. Despite national guidelines recommending universal patient access, hospitals face significant barriers to offering inpatient LARCs. It is unclear why some hospitals successfully implement immediate postpartum LARCs, while others do not.

Moniz et al conducted a comparative, multiple case study of immediate postpartum LARC implementation at eleven “early adopter” U.S. hospitals and analyzed each hospital’s implementation strategy to produce generalizable knowledge about how and under what circumstances implementation of immediate postpartum LARCs unfold successfully. Between 2017-2018, the authors conducted single-day site visits and 78 semi-structured interviews with a variety of stakeholders (clinician champions, nurses, pharmacists, revenue cycle staff, and hospital administration). On average, sites used 18 (range 11-22) implementation strategies, including assessing institutional readiness for, and barriers to, implementation of immediate postpartum LARC, engaging reproductive justice experts and community resources to address social determinants of health, involving patients in implementation planning, and developing quality monitoring processes to evaluate clinical processes and outcomes. The researchers found that successful implementation of immediate postpartum LARC required three essential conditions: effective implementation champions who are supported by a multidisciplinary implementation team; creating an enabling financial environment; and engaging hospital administration. Additional findings from this study call for more support for individuals leading change in complex care settings, intentionally designing implementation interventions that take into account local contextual influences, and meaningfully engaging patients in the implementation process.

Of postpartum women, 61% in low- and middle-income countries (LMIC) have an unmet contraceptive need and many face high rates of short interpregnancy intervals (Moore). Additionally, 51%-96% of postpartum women in LMIC use short-acting methods of contraception (Moore), further highlighting the need for increased access to immediate postpartum LARC in LMIC. Data on the use and continuation of immediate postpartum LARC in LMIC is limited. Marchin et al conducted a systematic review and meta-analysis to determine 6-month continuation rates of immediate postpartum LARCs among women in 69 low-income countries that were enrolled in the Family Planning 2020 initiative. The meta-analysis ultimately focused on the copper IUD due to the absence of relevant studies on other LARC methods. The meta-analysis of 12 studies resulted in a pooled 6-month continuation rate for immediate postpartum copper IUDs of 87%, a rate comparable to continuation rates found in higher-income countries. This estimate had significant heterogeneity between studies. Secondary outcomes of expulsion, removal, and infection rates were low at 6%, 5%, and 0.2% respectively. High 6-month continuation rates and a low rate of adverse outcomes suggest immediate postpartum copper IUD insertion represents a feasible and acceptable postpartum contraceptive option for women living in LMIC.

In cases where contraception methods fail, are used incorrectly, or are not used at all, emergency contraception (EC) can be used after intercourse to prevent pregnancy. Timely access to, and accurate knowledge of, EC are especially important for rural women who are more likely to experience an unintended pregnancy resulting in a live birth compared to urban women. Milkowski et al analyzed publicly available data from the National Survey of Family Growth to estimate differences in oral EC use, access, and counseling by rural-urban county of residence among U.S. women aged 15-44 years. 10% of rural and 19% of urban women who had ever been sexually active reported ever using EC pills. Over the course of the study period (2006-2017), the percentage of women reporting ever-use of EC increased linearly in both rural and urban populations, with the prevalence of EC ever-use more than doubling in each group. This observation likely reflects an overall increase in EC use during a time period in which the federal government enacted several policies to improve access to EC. The study findings also highlight the need for improved patient counseling on EC. While the overall prevalence of EC counseling was low among all women, rural women were less likely to have received counseling on EC when compared to urban women.

Although many studies report weight gain in users of progestin-only hormonal contraception (POC), a recent Cochrane systematic review found that there was insufficient evidence to determine the effect of POCs on weight (Lopez). Beksinska et al conducted a secondary analysis of prospective weight change among women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial, which was an open label, prospective, randomized multicenter trial that compared the risk of HIV acquisition among women randomized to injectable contraception (DMPA), the copper IUD, or a second generation two rod levonorgestrel (LNG) implant Jadelle^Ò. This trial was conducted at 12 sites across four African countries between 2015 and 2018. Eligible study participants were nonpregnant, HIV negative, sexually active women aged 16-35 years who desired contraception. The final sample size included 7,014 women randomly assigned to receive DMPA (2,293), the LNG implant (2,372), or the copper IUD (2,349). Using a standardized protocol and calibrated equipment across all study sites, weight and height were measured at baseline and at study exit at 12, 15, or 18 months. The mean weight increased amongst all three contraceptive groups and was significantly different in magnitude, with the largest gain in the DMPA group (3.5 kg), 2.4 kg in the LNG implant group, and 1.5 kg in the copper IUD group. Unlike copper IUD users, women in the DMPA and LNG implant group continued to gain weight after 1 year of contraceptive use. It is noteworthy that, regardless of contraceptive method allocation, not all women gained weight and a small proportion of women lost weight. When choosing a contraceptive method, women using POCs should be counselled about the potential side effect of weight gain.

References:
Moniz MH, Bonawitz K, Wetmore MK, et al. Implementing immediate postpartum contraception: a comparative case study at 11 hospitals. Implement Sci Commun. 2021;2(1):42. Published 2021 Apr 12.

Moore Z, Pfitzer A, Gubin R, et al. Missed opportunities for family planning: an analysis of pregnancy risk and contraceptive method use among postpartum women in 21 low- and middle-income countries. Contraception 92 (2015): 31–39.
 

Marchin A, Moss A, Harrison M. A Meta-Analysis of Postpartum Copper IUD Continuation Rates in Low- and Middle-Income Countries. J Womens Health Dev. 2021;4(1):36-46.

Milkowski CM, Ziller EC, Ahrens KA. Rural-urban residence and emergency contraception use, access, and counseling in the United States, 2006-2017. Contracept X. 2021;3:100061.

Lopez L.M., Ramesh S., Chen M. Progestin-only contraceptives: effects on weight. Cochrane Database Syst Rev. 2016 doi: 10.1002/14651858.CD008815.pub2.

Beksinska et al. “Weight change among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Findings from a randomised, multicentre, open-label trial. EClinicalMedicine. 2021;34:100800.

Immediate postpartum long-acting reversible contraception (LARC) represents a safe and effective contraceptive strategy. Despite national guidelines recommending universal patient access, hospitals face significant barriers to offering inpatient LARCs. It is unclear why some hospitals successfully implement immediate postpartum LARCs, while others do not.

Moniz et al conducted a comparative, multiple case study of immediate postpartum LARC implementation at eleven “early adopter” U.S. hospitals and analyzed each hospital’s implementation strategy to produce generalizable knowledge about how and under what circumstances implementation of immediate postpartum LARCs unfold successfully. Between 2017-2018, the authors conducted single-day site visits and 78 semi-structured interviews with a variety of stakeholders (clinician champions, nurses, pharmacists, revenue cycle staff, and hospital administration). On average, sites used 18 (range 11-22) implementation strategies, including assessing institutional readiness for, and barriers to, implementation of immediate postpartum LARC, engaging reproductive justice experts and community resources to address social determinants of health, involving patients in implementation planning, and developing quality monitoring processes to evaluate clinical processes and outcomes. The researchers found that successful implementation of immediate postpartum LARC required three essential conditions: effective implementation champions who are supported by a multidisciplinary implementation team; creating an enabling financial environment; and engaging hospital administration. Additional findings from this study call for more support for individuals leading change in complex care settings, intentionally designing implementation interventions that take into account local contextual influences, and meaningfully engaging patients in the implementation process.

Of postpartum women, 61% in low- and middle-income countries (LMIC) have an unmet contraceptive need and many face high rates of short interpregnancy intervals (Moore). Additionally, 51%-96% of postpartum women in LMIC use short-acting methods of contraception (Moore), further highlighting the need for increased access to immediate postpartum LARC in LMIC. Data on the use and continuation of immediate postpartum LARC in LMIC is limited. Marchin et al conducted a systematic review and meta-analysis to determine 6-month continuation rates of immediate postpartum LARCs among women in 69 low-income countries that were enrolled in the Family Planning 2020 initiative. The meta-analysis ultimately focused on the copper IUD due to the absence of relevant studies on other LARC methods. The meta-analysis of 12 studies resulted in a pooled 6-month continuation rate for immediate postpartum copper IUDs of 87%, a rate comparable to continuation rates found in higher-income countries. This estimate had significant heterogeneity between studies. Secondary outcomes of expulsion, removal, and infection rates were low at 6%, 5%, and 0.2% respectively. High 6-month continuation rates and a low rate of adverse outcomes suggest immediate postpartum copper IUD insertion represents a feasible and acceptable postpartum contraceptive option for women living in LMIC.

In cases where contraception methods fail, are used incorrectly, or are not used at all, emergency contraception (EC) can be used after intercourse to prevent pregnancy. Timely access to, and accurate knowledge of, EC are especially important for rural women who are more likely to experience an unintended pregnancy resulting in a live birth compared to urban women. Milkowski et al analyzed publicly available data from the National Survey of Family Growth to estimate differences in oral EC use, access, and counseling by rural-urban county of residence among U.S. women aged 15-44 years. 10% of rural and 19% of urban women who had ever been sexually active reported ever using EC pills. Over the course of the study period (2006-2017), the percentage of women reporting ever-use of EC increased linearly in both rural and urban populations, with the prevalence of EC ever-use more than doubling in each group. This observation likely reflects an overall increase in EC use during a time period in which the federal government enacted several policies to improve access to EC. The study findings also highlight the need for improved patient counseling on EC. While the overall prevalence of EC counseling was low among all women, rural women were less likely to have received counseling on EC when compared to urban women.

Although many studies report weight gain in users of progestin-only hormonal contraception (POC), a recent Cochrane systematic review found that there was insufficient evidence to determine the effect of POCs on weight (Lopez). Beksinska et al conducted a secondary analysis of prospective weight change among women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial, which was an open label, prospective, randomized multicenter trial that compared the risk of HIV acquisition among women randomized to injectable contraception (DMPA), the copper IUD, or a second generation two rod levonorgestrel (LNG) implant Jadelle^Ò. This trial was conducted at 12 sites across four African countries between 2015 and 2018. Eligible study participants were nonpregnant, HIV negative, sexually active women aged 16-35 years who desired contraception. The final sample size included 7,014 women randomly assigned to receive DMPA (2,293), the LNG implant (2,372), or the copper IUD (2,349). Using a standardized protocol and calibrated equipment across all study sites, weight and height were measured at baseline and at study exit at 12, 15, or 18 months. The mean weight increased amongst all three contraceptive groups and was significantly different in magnitude, with the largest gain in the DMPA group (3.5 kg), 2.4 kg in the LNG implant group, and 1.5 kg in the copper IUD group. Unlike copper IUD users, women in the DMPA and LNG implant group continued to gain weight after 1 year of contraceptive use. It is noteworthy that, regardless of contraceptive method allocation, not all women gained weight and a small proportion of women lost weight. When choosing a contraceptive method, women using POCs should be counselled about the potential side effect of weight gain.

References:
Moniz MH, Bonawitz K, Wetmore MK, et al. Implementing immediate postpartum contraception: a comparative case study at 11 hospitals. Implement Sci Commun. 2021;2(1):42. Published 2021 Apr 12.

Moore Z, Pfitzer A, Gubin R, et al. Missed opportunities for family planning: an analysis of pregnancy risk and contraceptive method use among postpartum women in 21 low- and middle-income countries. Contraception 92 (2015): 31–39.
 

Marchin A, Moss A, Harrison M. A Meta-Analysis of Postpartum Copper IUD Continuation Rates in Low- and Middle-Income Countries. J Womens Health Dev. 2021;4(1):36-46.

Milkowski CM, Ziller EC, Ahrens KA. Rural-urban residence and emergency contraception use, access, and counseling in the United States, 2006-2017. Contracept X. 2021;3:100061.

Lopez L.M., Ramesh S., Chen M. Progestin-only contraceptives: effects on weight. Cochrane Database Syst Rev. 2016 doi: 10.1002/14651858.CD008815.pub2.

Beksinska et al. “Weight change among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Findings from a randomised, multicentre, open-label trial. EClinicalMedicine. 2021;34:100800.

Immediate postpartum long-acting reversible contraception (LARC) represents a safe and effective contraceptive strategy. Despite national guidelines recommending universal patient access, hospitals face significant barriers to offering inpatient LARCs. It is unclear why some hospitals successfully implement immediate postpartum LARCs, while others do not.

Moniz et al conducted a comparative, multiple case study of immediate postpartum LARC implementation at eleven “early adopter” U.S. hospitals and analyzed each hospital’s implementation strategy to produce generalizable knowledge about how and under what circumstances implementation of immediate postpartum LARCs unfold successfully. Between 2017-2018, the authors conducted single-day site visits and 78 semi-structured interviews with a variety of stakeholders (clinician champions, nurses, pharmacists, revenue cycle staff, and hospital administration). On average, sites used 18 (range 11-22) implementation strategies, including assessing institutional readiness for, and barriers to, implementation of immediate postpartum LARC, engaging reproductive justice experts and community resources to address social determinants of health, involving patients in implementation planning, and developing quality monitoring processes to evaluate clinical processes and outcomes. The researchers found that successful implementation of immediate postpartum LARC required three essential conditions: effective implementation champions who are supported by a multidisciplinary implementation team; creating an enabling financial environment; and engaging hospital administration. Additional findings from this study call for more support for individuals leading change in complex care settings, intentionally designing implementation interventions that take into account local contextual influences, and meaningfully engaging patients in the implementation process.

Of postpartum women, 61% in low- and middle-income countries (LMIC) have an unmet contraceptive need and many face high rates of short interpregnancy intervals (Moore). Additionally, 51%-96% of postpartum women in LMIC use short-acting methods of contraception (Moore), further highlighting the need for increased access to immediate postpartum LARC in LMIC. Data on the use and continuation of immediate postpartum LARC in LMIC is limited. Marchin et al conducted a systematic review and meta-analysis to determine 6-month continuation rates of immediate postpartum LARCs among women in 69 low-income countries that were enrolled in the Family Planning 2020 initiative. The meta-analysis ultimately focused on the copper IUD due to the absence of relevant studies on other LARC methods. The meta-analysis of 12 studies resulted in a pooled 6-month continuation rate for immediate postpartum copper IUDs of 87%, a rate comparable to continuation rates found in higher-income countries. This estimate had significant heterogeneity between studies. Secondary outcomes of expulsion, removal, and infection rates were low at 6%, 5%, and 0.2% respectively. High 6-month continuation rates and a low rate of adverse outcomes suggest immediate postpartum copper IUD insertion represents a feasible and acceptable postpartum contraceptive option for women living in LMIC.

In cases where contraception methods fail, are used incorrectly, or are not used at all, emergency contraception (EC) can be used after intercourse to prevent pregnancy. Timely access to, and accurate knowledge of, EC are especially important for rural women who are more likely to experience an unintended pregnancy resulting in a live birth compared to urban women. Milkowski et al analyzed publicly available data from the National Survey of Family Growth to estimate differences in oral EC use, access, and counseling by rural-urban county of residence among U.S. women aged 15-44 years. 10% of rural and 19% of urban women who had ever been sexually active reported ever using EC pills. Over the course of the study period (2006-2017), the percentage of women reporting ever-use of EC increased linearly in both rural and urban populations, with the prevalence of EC ever-use more than doubling in each group. This observation likely reflects an overall increase in EC use during a time period in which the federal government enacted several policies to improve access to EC. The study findings also highlight the need for improved patient counseling on EC. While the overall prevalence of EC counseling was low among all women, rural women were less likely to have received counseling on EC when compared to urban women.

Although many studies report weight gain in users of progestin-only hormonal contraception (POC), a recent Cochrane systematic review found that there was insufficient evidence to determine the effect of POCs on weight (Lopez). Beksinska et al conducted a secondary analysis of prospective weight change among women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial, which was an open label, prospective, randomized multicenter trial that compared the risk of HIV acquisition among women randomized to injectable contraception (DMPA), the copper IUD, or a second generation two rod levonorgestrel (LNG) implant Jadelle^Ò. This trial was conducted at 12 sites across four African countries between 2015 and 2018. Eligible study participants were nonpregnant, HIV negative, sexually active women aged 16-35 years who desired contraception. The final sample size included 7,014 women randomly assigned to receive DMPA (2,293), the LNG implant (2,372), or the copper IUD (2,349). Using a standardized protocol and calibrated equipment across all study sites, weight and height were measured at baseline and at study exit at 12, 15, or 18 months. The mean weight increased amongst all three contraceptive groups and was significantly different in magnitude, with the largest gain in the DMPA group (3.5 kg), 2.4 kg in the LNG implant group, and 1.5 kg in the copper IUD group. Unlike copper IUD users, women in the DMPA and LNG implant group continued to gain weight after 1 year of contraceptive use. It is noteworthy that, regardless of contraceptive method allocation, not all women gained weight and a small proportion of women lost weight. When choosing a contraceptive method, women using POCs should be counselled about the potential side effect of weight gain.

References:
Moniz MH, Bonawitz K, Wetmore MK, et al. Implementing immediate postpartum contraception: a comparative case study at 11 hospitals. Implement Sci Commun. 2021;2(1):42. Published 2021 Apr 12.

Moore Z, Pfitzer A, Gubin R, et al. Missed opportunities for family planning: an analysis of pregnancy risk and contraceptive method use among postpartum women in 21 low- and middle-income countries. Contraception 92 (2015): 31–39.
 

Marchin A, Moss A, Harrison M. A Meta-Analysis of Postpartum Copper IUD Continuation Rates in Low- and Middle-Income Countries. J Womens Health Dev. 2021;4(1):36-46.

Milkowski CM, Ziller EC, Ahrens KA. Rural-urban residence and emergency contraception use, access, and counseling in the United States, 2006-2017. Contracept X. 2021;3:100061.

Lopez L.M., Ramesh S., Chen M. Progestin-only contraceptives: effects on weight. Cochrane Database Syst Rev. 2016 doi: 10.1002/14651858.CD008815.pub2.

Beksinska et al. “Weight change among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Findings from a randomised, multicentre, open-label trial. EClinicalMedicine. 2021;34:100800.

Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.

“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.

“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).

Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
 

‘Alarming’ early data

Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.

As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.

A total of 157 (21.5%) participants seroconverted during the study period.

Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.

The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).

Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.

Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
 

Limitations and caveats

They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.

The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.

“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.

They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.

The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”  

Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .

“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.

Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.

Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.

COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.

“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.

“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).

Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
 

‘Alarming’ early data

Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.

As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.

A total of 157 (21.5%) participants seroconverted during the study period.

Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.

The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).

Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.

Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
 

Limitations and caveats

They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.

The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.

“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.

They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.

The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”  

Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .

“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.

Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.

Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.

COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.

“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.

“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).

Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
 

‘Alarming’ early data

Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.

As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.

A total of 157 (21.5%) participants seroconverted during the study period.

Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.

The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).

Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.

Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
 

Limitations and caveats

They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.

The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.

“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.

They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.

The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”  

Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .

“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.

Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.

Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.

COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients who receive the mRNA COVID-19 vaccines are experiencing a variety of skin rashes, a dermatologist told colleagues, and some lesions don’t appear until several days after an injection. The good news is that these side effects tend to be minor and vanish within a few days, Esther Freeman, MD, PhD, said in a presentation at the American Academy of Dermatology Virtual Meeting Experience.

“The reality is actually very reassuring,” Dr. Freeman said, especially in light of what is currently known about when the rashes occur and how anaphylaxis is extremely uncommon. Now, she added, dermatologists can tell patients who had reactions to their initial vaccination that “we know you had this big reaction, and we know that it was upsetting and uncomfortable. But it may not happen the second time around. And if it does, [the reaction is] probably going to be smaller.”

Dr. Freeman, associate professor of dermatology at Harvard Medical School, Boston, highlighted a study published in the Journal of the American Academy of Dermatology that she coauthored with dermatologists across the United States. The researchers tracked 414 cutaneous reactions to the Moderna (83%) and Pfizer (17%) COVID-19 vaccines in a group of patients, which was 90% female, 78% White, and mostly from the United States. Their average age was 44 years. The cases were reported to the AAD–International League of Dermatological Societies registry of COVID-19 cutaneous manifestations.

While most were women, “it’s a little hard to know if this is really going to end up being a true finding,” said Dr. Freeman, the registry’s principal investigator and a member of the AAD’s COVID-19 Ad Hoc Task Force. “If you think about who got vaccinated early, it was health care providers, and the American health care workforce is over 70% female. So I think there’s a little bit of bias here. There may also be a bias because women may be slightly more likely to report or go to their health care provider for a rash.”

Delayed large local reactions were the most common, accounting for 66% (175 cases) of the 267 skin reactions reported after the first Moderna vaccine dose and 30% (31 cases) of the 102 reactions reported after the second dose. These reactions represented 15% (5 cases) of the 34 skin reactions reported after the first Pfizer vaccine dose and 18% (7 cases) of the 40 reactions after the second dose.

There are two peaks with that first dose, Dr. Freeman said. “There’s a peak around day 2 or 3. And there’s another peak around day 7 or 8 with some of these reactions. Only 27% who had a reaction with the first dose had the same reaction with the second.” She added that these reactions “are not cellulitis and don’t require antibiotics.”

Other more common reactions included local injection-site reactions (swelling, erythema, and pain), urticaria (after 24 hours in almost all cases, occurring at a higher rate in patients who received the Pfizer vaccine), and morbilliform eruptions.

Dr. Freeman said that patients may experience redness and swelling in the hands and feet that can be “very uncomfortable.” She described one patient “who was having a hard time actually closing his fist, just because of the amount of swelling and redness in his hand. It did resolve, and it’s important to reassure your patients it will go away.”

According to this study, less common reports of other cutaneous findings with both vaccines included 9 reports of swelling at the site of cosmetic fillers, 8 reports of pernio/chilblains, 10 reports of varicella zoster, 4 reports of herpes simplex flares, 4 pityriasis rosea–like reactions, and 4 rashes in infants of vaccinated breastfeeding mothers.

The study noted that “patients responded well to topical corticosteroids, oral antihistamines, and/or pain-relieving medications. These reactions resolved after a median of 3-4 days.”

It’s important to understand that none of the patients developed anaphylaxis after the second dose even if they’d had a reaction to the first dose, Dr. Freeman said. “But I should point out that we’re talking about reactions that have started more than 4 hours after the vaccine. If a rash such as a urticaria specifically starts within 4 hours of vaccination, that’s in a different category. Those are considered more immediate allergic reactions, and those patients need to be seen by allergy before a second dose.”

Dr. Freeman added that “it’s really interesting to think about how our bodies are really reacting to the vaccine in a way that’s mimicking our body’s reactions to COVID-19.” For example, some patients who got vaccinated developed chilblains similar to the “COVID toes” described in infected patients, apparently as part of the body’s immune response to the virus. “We’ve seen this in patients who actually had COVID and had prior COVID toes and then actually got a flare with their vaccine. And then we’ve also seen it in patients who never had COVID.”

In regard to general advice for patients, she said, “I do still encourage my patients who previously had COVID to go ahead and get the vaccine even if they had a skin manifestation with COVID.”

Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, said she has have seen only a handful of cases of delayed large local reactions and local injection site reactions after COVID-19 vaccination. “I have seen a significant number of cases of acute urticaria following the first and second doses,” she said in an interview. “However, it is important to keep in mind that we cannot determine cause and effect for the cases of acute urticaria. They may or may not be vaccine related.”

Fortunately, none of the adverse effects she’s seen have been severe. “It is important that dermatologists educate the public and their patients that most people do not develop any skin reaction in response to the vaccine,” she said. In the minority who do, “reactions tend to be mild and are not life-threatening. Many of these skin reactions resolve on their own without treatment.”

She added that “patients with pernio/chilblains or herpes zoster following vaccination should be referred by a board-certified dermatologist for prompt treatment and to avoid sequelae.”


 

‘COVID vaccine arm’

Delayed local reactions to the Moderna vaccine were also described in a report published online on May 12, 2021, in JAMA Dermatology, after the AAD meeting, in 16 patients referred to the Yale New Haven (Conn.) Hospital Dermatology service who experienced delayed localized cutaneous hypersensitivity reactions a median of 7 days after receiving the vaccine (range, 2-12 days), from Jan. 20 to Feb. 12, 2021. No such cases were reported in Pfizer vaccine recipients.

Of the 16 patients, whose median age was 38 years and who were mostly women, 15 developed the reaction after the first dose, described as “pruritic and variably painful erythematous reactions near the injection site,” which lasted a median of 5 days (range, 1-21 days). After the second dose, 12 of the 16 patients developed injection-site reactions (including one patient who had no reaction after dose 1), a median of 2 days after the vaccine was administered (range, 0-5 days). Histologic results of a biopsy in one patient with a reaction to the second dose “ demonstrated mild predominantly perivascular and focal interstitial mixed infiltrate with lymphocytes and eosinophils consistent with a dermal hypersensitivity reaction,” wrote Alicia J. Little, MD, PhD, of the department of dermatology, Yale University, New Haven, and coauthors.

Compared with immediate hypersensitivity reactions, occurring within 4 hours of vaccination, such as anaphylaxis and urticaria, they concluded that “these delayed localized hypersensitivity reactions are not a contraindication to subsequent vaccination,” and they proposed that they be named “COVID vaccine arm.”

Dr. Freeman reported no disclosures. Dr. Lipner also had no relevant disclosures. Dr. Little reported receiving a grant from the National Center for Advancing Translational Science and a Women’s Health Career Development Award from the Dermatology Foundation while the study was conducted; another author reported equity in Johnson & Johnson in his spouse’s retirement fund outside the submitted work.
 

Patients who receive the mRNA COVID-19 vaccines are experiencing a variety of skin rashes, a dermatologist told colleagues, and some lesions don’t appear until several days after an injection. The good news is that these side effects tend to be minor and vanish within a few days, Esther Freeman, MD, PhD, said in a presentation at the American Academy of Dermatology Virtual Meeting Experience.

“The reality is actually very reassuring,” Dr. Freeman said, especially in light of what is currently known about when the rashes occur and how anaphylaxis is extremely uncommon. Now, she added, dermatologists can tell patients who had reactions to their initial vaccination that “we know you had this big reaction, and we know that it was upsetting and uncomfortable. But it may not happen the second time around. And if it does, [the reaction is] probably going to be smaller.”

Dr. Freeman, associate professor of dermatology at Harvard Medical School, Boston, highlighted a study published in the Journal of the American Academy of Dermatology that she coauthored with dermatologists across the United States. The researchers tracked 414 cutaneous reactions to the Moderna (83%) and Pfizer (17%) COVID-19 vaccines in a group of patients, which was 90% female, 78% White, and mostly from the United States. Their average age was 44 years. The cases were reported to the AAD–International League of Dermatological Societies registry of COVID-19 cutaneous manifestations.

While most were women, “it’s a little hard to know if this is really going to end up being a true finding,” said Dr. Freeman, the registry’s principal investigator and a member of the AAD’s COVID-19 Ad Hoc Task Force. “If you think about who got vaccinated early, it was health care providers, and the American health care workforce is over 70% female. So I think there’s a little bit of bias here. There may also be a bias because women may be slightly more likely to report or go to their health care provider for a rash.”

Delayed large local reactions were the most common, accounting for 66% (175 cases) of the 267 skin reactions reported after the first Moderna vaccine dose and 30% (31 cases) of the 102 reactions reported after the second dose. These reactions represented 15% (5 cases) of the 34 skin reactions reported after the first Pfizer vaccine dose and 18% (7 cases) of the 40 reactions after the second dose.

There are two peaks with that first dose, Dr. Freeman said. “There’s a peak around day 2 or 3. And there’s another peak around day 7 or 8 with some of these reactions. Only 27% who had a reaction with the first dose had the same reaction with the second.” She added that these reactions “are not cellulitis and don’t require antibiotics.”

Other more common reactions included local injection-site reactions (swelling, erythema, and pain), urticaria (after 24 hours in almost all cases, occurring at a higher rate in patients who received the Pfizer vaccine), and morbilliform eruptions.

Dr. Freeman said that patients may experience redness and swelling in the hands and feet that can be “very uncomfortable.” She described one patient “who was having a hard time actually closing his fist, just because of the amount of swelling and redness in his hand. It did resolve, and it’s important to reassure your patients it will go away.”

According to this study, less common reports of other cutaneous findings with both vaccines included 9 reports of swelling at the site of cosmetic fillers, 8 reports of pernio/chilblains, 10 reports of varicella zoster, 4 reports of herpes simplex flares, 4 pityriasis rosea–like reactions, and 4 rashes in infants of vaccinated breastfeeding mothers.

The study noted that “patients responded well to topical corticosteroids, oral antihistamines, and/or pain-relieving medications. These reactions resolved after a median of 3-4 days.”

It’s important to understand that none of the patients developed anaphylaxis after the second dose even if they’d had a reaction to the first dose, Dr. Freeman said. “But I should point out that we’re talking about reactions that have started more than 4 hours after the vaccine. If a rash such as a urticaria specifically starts within 4 hours of vaccination, that’s in a different category. Those are considered more immediate allergic reactions, and those patients need to be seen by allergy before a second dose.”

Dr. Freeman added that “it’s really interesting to think about how our bodies are really reacting to the vaccine in a way that’s mimicking our body’s reactions to COVID-19.” For example, some patients who got vaccinated developed chilblains similar to the “COVID toes” described in infected patients, apparently as part of the body’s immune response to the virus. “We’ve seen this in patients who actually had COVID and had prior COVID toes and then actually got a flare with their vaccine. And then we’ve also seen it in patients who never had COVID.”

In regard to general advice for patients, she said, “I do still encourage my patients who previously had COVID to go ahead and get the vaccine even if they had a skin manifestation with COVID.”

Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, said she has have seen only a handful of cases of delayed large local reactions and local injection site reactions after COVID-19 vaccination. “I have seen a significant number of cases of acute urticaria following the first and second doses,” she said in an interview. “However, it is important to keep in mind that we cannot determine cause and effect for the cases of acute urticaria. They may or may not be vaccine related.”

Fortunately, none of the adverse effects she’s seen have been severe. “It is important that dermatologists educate the public and their patients that most people do not develop any skin reaction in response to the vaccine,” she said. In the minority who do, “reactions tend to be mild and are not life-threatening. Many of these skin reactions resolve on their own without treatment.”

She added that “patients with pernio/chilblains or herpes zoster following vaccination should be referred by a board-certified dermatologist for prompt treatment and to avoid sequelae.”


 

‘COVID vaccine arm’

Delayed local reactions to the Moderna vaccine were also described in a report published online on May 12, 2021, in JAMA Dermatology, after the AAD meeting, in 16 patients referred to the Yale New Haven (Conn.) Hospital Dermatology service who experienced delayed localized cutaneous hypersensitivity reactions a median of 7 days after receiving the vaccine (range, 2-12 days), from Jan. 20 to Feb. 12, 2021. No such cases were reported in Pfizer vaccine recipients.

Of the 16 patients, whose median age was 38 years and who were mostly women, 15 developed the reaction after the first dose, described as “pruritic and variably painful erythematous reactions near the injection site,” which lasted a median of 5 days (range, 1-21 days). After the second dose, 12 of the 16 patients developed injection-site reactions (including one patient who had no reaction after dose 1), a median of 2 days after the vaccine was administered (range, 0-5 days). Histologic results of a biopsy in one patient with a reaction to the second dose “ demonstrated mild predominantly perivascular and focal interstitial mixed infiltrate with lymphocytes and eosinophils consistent with a dermal hypersensitivity reaction,” wrote Alicia J. Little, MD, PhD, of the department of dermatology, Yale University, New Haven, and coauthors.

Compared with immediate hypersensitivity reactions, occurring within 4 hours of vaccination, such as anaphylaxis and urticaria, they concluded that “these delayed localized hypersensitivity reactions are not a contraindication to subsequent vaccination,” and they proposed that they be named “COVID vaccine arm.”

Dr. Freeman reported no disclosures. Dr. Lipner also had no relevant disclosures. Dr. Little reported receiving a grant from the National Center for Advancing Translational Science and a Women’s Health Career Development Award from the Dermatology Foundation while the study was conducted; another author reported equity in Johnson & Johnson in his spouse’s retirement fund outside the submitted work.
 

Patients who receive the mRNA COVID-19 vaccines are experiencing a variety of skin rashes, a dermatologist told colleagues, and some lesions don’t appear until several days after an injection. The good news is that these side effects tend to be minor and vanish within a few days, Esther Freeman, MD, PhD, said in a presentation at the American Academy of Dermatology Virtual Meeting Experience.

“The reality is actually very reassuring,” Dr. Freeman said, especially in light of what is currently known about when the rashes occur and how anaphylaxis is extremely uncommon. Now, she added, dermatologists can tell patients who had reactions to their initial vaccination that “we know you had this big reaction, and we know that it was upsetting and uncomfortable. But it may not happen the second time around. And if it does, [the reaction is] probably going to be smaller.”

Dr. Freeman, associate professor of dermatology at Harvard Medical School, Boston, highlighted a study published in the Journal of the American Academy of Dermatology that she coauthored with dermatologists across the United States. The researchers tracked 414 cutaneous reactions to the Moderna (83%) and Pfizer (17%) COVID-19 vaccines in a group of patients, which was 90% female, 78% White, and mostly from the United States. Their average age was 44 years. The cases were reported to the AAD–International League of Dermatological Societies registry of COVID-19 cutaneous manifestations.

While most were women, “it’s a little hard to know if this is really going to end up being a true finding,” said Dr. Freeman, the registry’s principal investigator and a member of the AAD’s COVID-19 Ad Hoc Task Force. “If you think about who got vaccinated early, it was health care providers, and the American health care workforce is over 70% female. So I think there’s a little bit of bias here. There may also be a bias because women may be slightly more likely to report or go to their health care provider for a rash.”

Delayed large local reactions were the most common, accounting for 66% (175 cases) of the 267 skin reactions reported after the first Moderna vaccine dose and 30% (31 cases) of the 102 reactions reported after the second dose. These reactions represented 15% (5 cases) of the 34 skin reactions reported after the first Pfizer vaccine dose and 18% (7 cases) of the 40 reactions after the second dose.

There are two peaks with that first dose, Dr. Freeman said. “There’s a peak around day 2 or 3. And there’s another peak around day 7 or 8 with some of these reactions. Only 27% who had a reaction with the first dose had the same reaction with the second.” She added that these reactions “are not cellulitis and don’t require antibiotics.”

Other more common reactions included local injection-site reactions (swelling, erythema, and pain), urticaria (after 24 hours in almost all cases, occurring at a higher rate in patients who received the Pfizer vaccine), and morbilliform eruptions.

Dr. Freeman said that patients may experience redness and swelling in the hands and feet that can be “very uncomfortable.” She described one patient “who was having a hard time actually closing his fist, just because of the amount of swelling and redness in his hand. It did resolve, and it’s important to reassure your patients it will go away.”

According to this study, less common reports of other cutaneous findings with both vaccines included 9 reports of swelling at the site of cosmetic fillers, 8 reports of pernio/chilblains, 10 reports of varicella zoster, 4 reports of herpes simplex flares, 4 pityriasis rosea–like reactions, and 4 rashes in infants of vaccinated breastfeeding mothers.

The study noted that “patients responded well to topical corticosteroids, oral antihistamines, and/or pain-relieving medications. These reactions resolved after a median of 3-4 days.”

It’s important to understand that none of the patients developed anaphylaxis after the second dose even if they’d had a reaction to the first dose, Dr. Freeman said. “But I should point out that we’re talking about reactions that have started more than 4 hours after the vaccine. If a rash such as a urticaria specifically starts within 4 hours of vaccination, that’s in a different category. Those are considered more immediate allergic reactions, and those patients need to be seen by allergy before a second dose.”

Dr. Freeman added that “it’s really interesting to think about how our bodies are really reacting to the vaccine in a way that’s mimicking our body’s reactions to COVID-19.” For example, some patients who got vaccinated developed chilblains similar to the “COVID toes” described in infected patients, apparently as part of the body’s immune response to the virus. “We’ve seen this in patients who actually had COVID and had prior COVID toes and then actually got a flare with their vaccine. And then we’ve also seen it in patients who never had COVID.”

In regard to general advice for patients, she said, “I do still encourage my patients who previously had COVID to go ahead and get the vaccine even if they had a skin manifestation with COVID.”

Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, said she has have seen only a handful of cases of delayed large local reactions and local injection site reactions after COVID-19 vaccination. “I have seen a significant number of cases of acute urticaria following the first and second doses,” she said in an interview. “However, it is important to keep in mind that we cannot determine cause and effect for the cases of acute urticaria. They may or may not be vaccine related.”

Fortunately, none of the adverse effects she’s seen have been severe. “It is important that dermatologists educate the public and their patients that most people do not develop any skin reaction in response to the vaccine,” she said. In the minority who do, “reactions tend to be mild and are not life-threatening. Many of these skin reactions resolve on their own without treatment.”

She added that “patients with pernio/chilblains or herpes zoster following vaccination should be referred by a board-certified dermatologist for prompt treatment and to avoid sequelae.”


 

‘COVID vaccine arm’

Delayed local reactions to the Moderna vaccine were also described in a report published online on May 12, 2021, in JAMA Dermatology, after the AAD meeting, in 16 patients referred to the Yale New Haven (Conn.) Hospital Dermatology service who experienced delayed localized cutaneous hypersensitivity reactions a median of 7 days after receiving the vaccine (range, 2-12 days), from Jan. 20 to Feb. 12, 2021. No such cases were reported in Pfizer vaccine recipients.

Of the 16 patients, whose median age was 38 years and who were mostly women, 15 developed the reaction after the first dose, described as “pruritic and variably painful erythematous reactions near the injection site,” which lasted a median of 5 days (range, 1-21 days). After the second dose, 12 of the 16 patients developed injection-site reactions (including one patient who had no reaction after dose 1), a median of 2 days after the vaccine was administered (range, 0-5 days). Histologic results of a biopsy in one patient with a reaction to the second dose “ demonstrated mild predominantly perivascular and focal interstitial mixed infiltrate with lymphocytes and eosinophils consistent with a dermal hypersensitivity reaction,” wrote Alicia J. Little, MD, PhD, of the department of dermatology, Yale University, New Haven, and coauthors.

Compared with immediate hypersensitivity reactions, occurring within 4 hours of vaccination, such as anaphylaxis and urticaria, they concluded that “these delayed localized hypersensitivity reactions are not a contraindication to subsequent vaccination,” and they proposed that they be named “COVID vaccine arm.”

Dr. Freeman reported no disclosures. Dr. Lipner also had no relevant disclosures. Dr. Little reported receiving a grant from the National Center for Advancing Translational Science and a Women’s Health Career Development Award from the Dermatology Foundation while the study was conducted; another author reported equity in Johnson & Johnson in his spouse’s retirement fund outside the submitted work.