Pub Date : 2025-02-01DOI: 10.1016/j.contraception.2024.110727
Marie Didembourg , Médéa Locquet , Lucie Raskin , Babel Tsague Tchimchoua , Jean-Michel Dogné , Charlotte Beaudart , Jonathan Douxfils
Objectives
Pharmacovigilance data analysis can accelerate the identification of drug-related safety signals or reassure on the safety profile. This study evaluates the venous thromboembolism (VTE) risk of newer combined oral contraceptive (COC) formulations with natural estrogens, such as estradiol (E2) and estetrol (E4), using data from the EudraVigilance database.
Study design
We conducted a disproportionality reporting rate analysis of VTE events associated with various COC formulations by extracting individual case reports from EudraVigilance database up to July 28, 2024. The study compared the proportionality reporting rate between natural estrogen-based COCs (E2 and E4) and conventional synthetic estrogen-based COCs (ethinylestradiol [EE]), with a comparison to EE-levonorgestrel.
Results
The analysis revealed that COCs containing natural estrogens exhibited significantly lower proportionality reporting rates for thrombotic events compared to EE-based COCs. Specifically, E4-drospirenone (E4-DRSP) showed the lowest proportionality reporting rate (0.12), similar to progestin-only pills. EE-DRSP had the highest proportionality reporting rate (2.25), suggesting an increased thrombotic risk.
Conclusions
The study supports the safer thrombotic profile of natural estrogen-based COCs, particularly E2 and E4 formulations, over synthetic estrogen-based COCs containing EE. These findings support the hypothesis that E2- and E4-based pills are safer than EE-based pills, aligning with a shift toward safer contraceptive options in clinical practice.
Implications
Natural estrogens such as E2 and E4 may emerge as safer alternatives to synthetic estrogens like EE, particularly when combined with progestins like DRSP. This multilevel evidence underscores the importance of evidence-based prescribing practices to enhance patient safety and minimize thrombotic risks associated with COC use.
{"title":"Lower reporting of venous thromboembolisms events with natural estrogen-based combined oral contraceptives compared to ethinylestradiol-containing pills: A disproportionality analysis of the Eudravigilance database","authors":"Marie Didembourg , Médéa Locquet , Lucie Raskin , Babel Tsague Tchimchoua , Jean-Michel Dogné , Charlotte Beaudart , Jonathan Douxfils","doi":"10.1016/j.contraception.2024.110727","DOIUrl":"10.1016/j.contraception.2024.110727","url":null,"abstract":"<div><h3>Objectives</h3><div>Pharmacovigilance data analysis can accelerate the identification of drug-related safety signals or reassure on the safety profile. This study evaluates the venous thromboembolism (VTE) risk of newer combined oral contraceptive (COC) formulations with natural estrogens, such as estradiol (E2) and estetrol (E4), using data from the EudraVigilance database.</div></div><div><h3>Study design</h3><div>We conducted a disproportionality reporting rate analysis of VTE events associated with various COC formulations by extracting individual case reports from EudraVigilance database up to July 28, 2024. The study compared the proportionality reporting rate between natural estrogen-based COCs (E2 and E4) and conventional synthetic estrogen-based COCs (ethinylestradiol [EE]), with a comparison to EE-levonorgestrel.</div></div><div><h3>Results</h3><div>The analysis revealed that COCs containing natural estrogens exhibited significantly lower proportionality reporting rates for thrombotic events compared to EE-based COCs. Specifically, E4-drospirenone (E4-DRSP) showed the lowest proportionality reporting rate (0.12), similar to progestin-only pills. EE-DRSP had the highest proportionality reporting rate (2.25), suggesting an increased thrombotic risk.</div></div><div><h3>Conclusions</h3><div>The study supports the safer thrombotic profile of natural estrogen-based COCs, particularly E2 and E4 formulations, over synthetic estrogen-based COCs containing EE. These findings support the hypothesis that E2- and E4-based pills are safer than EE-based pills, aligning with a shift toward safer contraceptive options in clinical practice.</div></div><div><h3>Implications</h3><div>Natural estrogens such as E2 and E4 may emerge as safer alternatives to synthetic estrogens like EE, particularly when combined with progestins like DRSP. This multilevel evidence underscores the importance of evidence-based prescribing practices to enhance patient safety and minimize thrombotic risks associated with COC use.</div></div>","PeriodicalId":10762,"journal":{"name":"Contraception","volume":"142 ","pages":"Article 110727"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142483226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.contraception.2024.110729
Brandon G. Wagner, Patricia Maloney, Ali Hooks
Objectives
To estimate the availability of the recently released over-the-counter (OTC) birth control pill (Opill) in retail pharmacies and compare availability across pharmacies based on their chain status and setting.
Study design
In April and May 2024, we conducted a mystery caller study of a sample of 500 Texas retail pharmacies. Sampled pharmacies were contacted by female project staff posing as potential customers and asked whether they had OTC birth control pills in stock and, if not, whether they could be ordered. We characterized pharmacies by chain status (independent pharmacy, chain pharmacy inside retail outlet, chain pharmacy with standalone location) and, using geolocation, as located in either rural or urban areas.
Results
Overall, 62% of pharmacies (N = 477) reported having Opill available for sale. This stock varied by pharmacy type, with independent pharmacies the least likely to stock it (25%) and standalone chain pharmacies the most likely (82%). Similar patterns were found in terms of pharmacies that had Opill in stock or were willing to order it. We found no significant differences between urban and rural pharmacies.
Conclusions
Despite its recent (March 2024) launch, Opill was widely available in retail pharmacies in Texas, though independent pharmacies were less likely to stock it. While removing the need for prescriptions may make birth control pills more accessible, this access may vary by pharmacy type.
Implications
Following its retail launch, the first OTC birth control pill in the United States is already widely available in pharmacies in Texas. As they are highly likely to stock these OTC pills, chain pharmacies (e.g., CVS, Walgreens, Rite-Aid) may be well positioned to address existing barriers to accessing birth control pills.
{"title":"Retail availability of over-the-counter birth control pills at Texas pharmacies: Results from a mystery caller study","authors":"Brandon G. Wagner, Patricia Maloney, Ali Hooks","doi":"10.1016/j.contraception.2024.110729","DOIUrl":"10.1016/j.contraception.2024.110729","url":null,"abstract":"<div><h3>Objectives</h3><div>To estimate the availability of the recently released over-the-counter (OTC) birth control pill (Opill) in retail pharmacies and compare availability across pharmacies based on their chain status and setting.</div></div><div><h3>Study design</h3><div>In April and May 2024, we conducted a mystery caller study of a sample of 500 Texas retail pharmacies. Sampled pharmacies were contacted by female project staff posing as potential customers and asked whether they had OTC birth control pills in stock and, if not, whether they could be ordered. We characterized pharmacies by chain status (independent pharmacy, chain pharmacy inside retail outlet, chain pharmacy with standalone location) and, using geolocation, as located in either rural or urban areas.</div></div><div><h3>Results</h3><div>Overall, 62% of pharmacies (<em>N</em> = 477) reported having Opill available for sale. This stock varied by pharmacy type, with independent pharmacies the least likely to stock it (25%) and standalone chain pharmacies the most likely (82%). Similar patterns were found in terms of pharmacies that had Opill in stock or were willing to order it. We found no significant differences between urban and rural pharmacies.</div></div><div><h3>Conclusions</h3><div>Despite its recent (March 2024) launch, Opill was widely available in retail pharmacies in Texas, though independent pharmacies were less likely to stock it. While removing the need for prescriptions may make birth control pills more accessible, this access may vary by pharmacy type.</div></div><div><h3>Implications</h3><div>Following its retail launch, the first OTC birth control pill in the United States is already widely available in pharmacies in Texas. As they are highly likely to stock these OTC pills, chain pharmacies (e.g., CVS, Walgreens, Rite-Aid) may be well positioned to address existing barriers to accessing birth control pills.</div></div>","PeriodicalId":10762,"journal":{"name":"Contraception","volume":"142 ","pages":"Article 110729"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142568229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.contraception.2024.110696
Lindsay Burton , Rachel Perry , Janet Jacobson
Objectives
To compare medication abortion (MAB) success in very early pregnancy (VEP) with mifepristone followed by either one or two doses of misoprostol.
Study design
We performed a retrospective cohort analysis of VEP MABs from July 1, 2021 to May 31, 2022 treated with mifepristone 200 mg oral followed by a single dose of misoprostol 800 mcg buccal 24 to 48 hours later and MABs from June 21, 2022 to October 31, 2022 treated with mifepristone 200 mg oral followed by two doses of misoprostol 800 mcg buccal spaced 4 hours apart, with first dose taken 24 to 48 hours after mifepristone. Serum BhCG was collected at the time of mifepristone treatment with additional BhCG collected 48 to 72 hours after misoprostol treatment in both groups. Success was defined as a BhCG decline of ≥50%. MAB failure was defined as ongoing, viable pregnancy determined by follow-up ultrasound or procedural intervention with aspiration.
Results
There were 423 patients in the single-dose misoprostol group and 262 patients in the two-dose misoprostol group. There were no significant differences between the two groups in baseline characteristics. In the single-dose group, 372 (87.9%) were treated successfully; in the two-dose group, 224 (85.5%) were treated successfully. There was no significant difference in MAB success between the groups (p = 0.73).
Conclusions
The addition of a second dose of misoprostol does not improve the success of MAB in VEP.
Implications
Additional research is needed to identify interventions to improve the success of MAB in VEP.
{"title":"Success of medication abortion with mifepristone followed by two doses of misoprostol in very early pregnancy","authors":"Lindsay Burton , Rachel Perry , Janet Jacobson","doi":"10.1016/j.contraception.2024.110696","DOIUrl":"10.1016/j.contraception.2024.110696","url":null,"abstract":"<div><h3>Objectives</h3><div>To compare medication abortion (MAB) success in very early pregnancy (VEP) with mifepristone followed by either one or two doses of misoprostol.</div></div><div><h3>Study design</h3><div>We performed a retrospective cohort analysis of VEP MABs from July 1, 2021 to May 31, 2022 treated with mifepristone 200 mg oral followed by a single dose of misoprostol 800 mcg buccal 24 to 48 hours later and MABs from June 21, 2022 to October 31, 2022 treated with mifepristone 200 mg oral followed by two doses of misoprostol 800 mcg buccal spaced 4 hours apart, with first dose taken 24 to 48 hours after mifepristone. Serum BhCG was collected at the time of mifepristone treatment with additional BhCG collected 48 to 72 hours after misoprostol treatment in both groups. Success was defined as a BhCG decline of ≥50%. MAB failure was defined as ongoing, viable pregnancy determined by follow-up ultrasound or procedural intervention with aspiration.</div></div><div><h3>Results</h3><div>There were 423 patients in the single-dose misoprostol group and 262 patients in the two-dose misoprostol group. There were no significant differences between the two groups in baseline characteristics. In the single-dose group, 372 (87.9%) were treated successfully; in the two-dose group, 224 (85.5%) were treated successfully. There was no significant difference in MAB success between the groups (<em>p</em> = 0.73).</div></div><div><h3>Conclusions</h3><div>The addition of a second dose of misoprostol does not improve the success of MAB in VEP.</div></div><div><h3>Implications</h3><div>Additional research is needed to identify interventions to improve the success of MAB in VEP.</div></div>","PeriodicalId":10762,"journal":{"name":"Contraception","volume":"142 ","pages":"Article 110696"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142115999","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.contraception.2024.110728
Taylore King , Eric Caliendo , Ericka Scott , Ghiara Lugo Diaz , Megan Lawley
We present a case of suspected hepatotoxicity secondary to an etonogestrel contraceptive implant in which the patient presented with vomiting, jaundice, pruritis, elevated transaminases, and hyperbilirubinemia. An extensive work-up, including liver biopsy, was unremarkable. The implant was removed and the patient’s symptoms and transaminitis resolved, suggestive of drug-induced liver injury.
{"title":"Suspected hepatotoxicity from etonogestrel contraceptive implant: A rare case report","authors":"Taylore King , Eric Caliendo , Ericka Scott , Ghiara Lugo Diaz , Megan Lawley","doi":"10.1016/j.contraception.2024.110728","DOIUrl":"10.1016/j.contraception.2024.110728","url":null,"abstract":"<div><div>We present a case of suspected hepatotoxicity secondary to an etonogestrel contraceptive implant in which the patient presented with vomiting, jaundice, pruritis, elevated transaminases, and hyperbilirubinemia. An extensive work-up, including liver biopsy, was unremarkable. The implant was removed and the patient’s symptoms and transaminitis resolved, suggestive of drug-induced liver injury.</div></div>","PeriodicalId":10762,"journal":{"name":"Contraception","volume":"142 ","pages":"Article 110728"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142483229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.contraception.2024.110720
Shawnalyn W. Sunagawa , Lee C. Winchester , Christopher S. Wichman , Sean N. Avedissian , David W. Erikson , Molly Kernan , Mark A. Marzinke , Timothy M. Mykris , Renu Nandakumar , Thomas D. Nolin , Anthony T. Podany , Raymond E. West III , Beatrice A. Chen , Catherine A. Chappell , Kimberly K. Scarsi
Objectives
To compare performance characteristics of etonogestrel bioanalytical assays across laboratories.
Study design
We conducted a blinded, six laboratory study: five academic laboratories and one contracted commercial laboratory (reference). Etonogestrel was quantitated at each laboratory in both prepared serum and/or plasma samples of six known etonogestrel concentrations, and in 60 clinical samples from participants using etonogestrel-containing contraceptive methods. Per regulatory guidance, laboratory accuracy (percent bias) and precision (coefficient of variation; CV) were defined as ±15% of the nominal prepared concentration. We compared inter- and intra-laboratory agreement using a Kendall’s Tau-B and Passing-Bablok regression.
Results
For prepared samples, six laboratories analyzed serum and three laboratories analyzed plasma. All etonogestrel results were within ±15% for accuracy across all concentrations at four labs, including the reference laboratory. All labs demonstrated high precision, with only one occurrence of CV >15%. We found a positive association between prepared plasma and serum etonogestrel results (Kendall’s Tau-B 0.80–0.88). For clinical samples, five laboratories analyzed serum and three laboratories analyzed plasma. Compared to the reference laboratory, inter-laboratory serum etonogestrel concentrations were positively correlated (Kendall’s Tau-B 0.76–0.95). Proportional bias was observed, meaning individual lab etonogestrel results were consistently higher (slope estimates 0.78–0.95) or lower (slope estimates 1.05–1.10) than the reference laboratory. In clinical samples, intra-laboratory results were well associated between plasma and serum (Kendall’s Tau-B 0.92–0.96).
Conclusions
There was good intra-laboratory agreement, irrespective of sample matrix; however, there was inter-laboratory variability in etonogestrel results. Differences between laboratory results should be considered when comparing etonogestrel pharmacokinetics across studies.
Implications
Etonogestrel concentrations were highly precise within each laboratory and were comparable between serum and plasma. Results varied between laboratories (5–28% higher to 5–9% lower compared to the Organon commercial laboratory). To minimize variability, we recommend utilizing a single laboratory that conducts routine proficiency testing for etonogestrel analysis within a study.
{"title":"Comparison of etonogestrel bioanalytical assay results in plasma and serum within and across laboratories","authors":"Shawnalyn W. Sunagawa , Lee C. Winchester , Christopher S. Wichman , Sean N. Avedissian , David W. Erikson , Molly Kernan , Mark A. Marzinke , Timothy M. Mykris , Renu Nandakumar , Thomas D. Nolin , Anthony T. Podany , Raymond E. West III , Beatrice A. Chen , Catherine A. Chappell , Kimberly K. Scarsi","doi":"10.1016/j.contraception.2024.110720","DOIUrl":"10.1016/j.contraception.2024.110720","url":null,"abstract":"<div><h3>Objectives</h3><div>To compare performance characteristics of etonogestrel bioanalytical assays across laboratories.</div></div><div><h3>Study design</h3><div>We conducted a blinded, six laboratory study: five academic laboratories and one contracted commercial laboratory (reference). Etonogestrel was quantitated at each laboratory in both prepared serum and/or plasma samples of six known etonogestrel concentrations, and in 60 clinical samples from participants using etonogestrel-containing contraceptive methods. Per regulatory guidance, laboratory accuracy (percent bias) and precision (coefficient of variation; CV) were defined as ±15% of the nominal prepared concentration. We compared inter- and intra-laboratory agreement using a Kendall’s Tau-B and Passing-Bablok regression.</div></div><div><h3>Results</h3><div>For prepared samples, six laboratories analyzed serum and three laboratories analyzed plasma. All etonogestrel results were within ±15% for accuracy across all concentrations at four labs, including the reference laboratory. All labs demonstrated high precision, with only one occurrence of CV >15%. We found a positive association between prepared plasma and serum etonogestrel results (Kendall’s Tau-B 0.80–0.88). For clinical samples, five laboratories analyzed serum and three laboratories analyzed plasma. Compared to the reference laboratory, inter-laboratory serum etonogestrel concentrations were positively correlated (Kendall’s Tau-B 0.76–0.95). Proportional bias was observed, meaning individual lab etonogestrel results were consistently higher (slope estimates 0.78–0.95) or lower (slope estimates 1.05–1.10) than the reference laboratory. In clinical samples, intra-laboratory results were well associated between plasma and serum (Kendall’s Tau-B 0.92–0.96).</div></div><div><h3>Conclusions</h3><div>There was good intra-laboratory agreement, irrespective of sample matrix; however, there was inter-laboratory variability in etonogestrel results. Differences between laboratory results should be considered when comparing etonogestrel pharmacokinetics across studies.</div></div><div><h3>Implications</h3><div>Etonogestrel concentrations were highly precise within each laboratory and were comparable between serum and plasma. Results varied between laboratories (5–28% higher to 5–9% lower compared to the Organon commercial laboratory). To minimize variability, we recommend utilizing a single laboratory that conducts routine proficiency testing for etonogestrel analysis within a study.</div></div>","PeriodicalId":10762,"journal":{"name":"Contraception","volume":"142 ","pages":"Article 110720"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11756928/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142373820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.contraception.2024.110723
William G. Axinn , Brady T. West , Heather M. Schroeder , Laura D. Lindberg
Objectives
The COVID-19 pandemic brought multiple simultaneous consequences, with high potential to change fertility-related behaviors. We use nationally representative sex and contraceptive use event history calendar measures to demonstrate person-specific changes in contraceptive use after the pandemic, showing differences across demographic subgroups.
Study design
We use data from the first nationally representative web survey of U.S. fertility, fielded in 2020–2022: the American Family Health Study (AFHS). Using responses from 1357 female-identifying respondents ages 18–49, we analyze 26,274 person-months of sex and contraceptive use data spanning directly before and after the beginning of the pandemic to detect change.
Results
Individual-level hazard models of starting and stopping contraception revealed no pandemic-related changes in starting contraception, but significant reductions in the rate of stopping contraception for specific subgroups. Hispanic females reduced their rates of stopping contraceptive use during the pandemic (lowering their odds of stopping use by 71%), ultimately behaving more similarly to individuals from other racial or ethnic subgroups. Additionally, those aged 41 and older significantly reduced their rates of stopping contraceptive use (lowering their odds of stopping use by 78%) relative to other age groups.
Conclusions
Sudden large-scale health policy changes can produce significant changes in contraceptive use behaviors. The COVID-19 changes interacted with race, ethnicity, and age to produce different changes in contraceptive behaviors among different subgroups of the U.S. population.
{"title":"Pandemic changes in U.S. contraceptive use: National survey estimates reveal significant differences by demographic subgroups","authors":"William G. Axinn , Brady T. West , Heather M. Schroeder , Laura D. Lindberg","doi":"10.1016/j.contraception.2024.110723","DOIUrl":"10.1016/j.contraception.2024.110723","url":null,"abstract":"<div><h3>Objectives</h3><div>The COVID-19 pandemic brought multiple simultaneous consequences, with high potential to change fertility-related behaviors. We use nationally representative sex and contraceptive use event history calendar measures to demonstrate person-specific changes in contraceptive use after the pandemic, showing differences across demographic subgroups.</div></div><div><h3>Study design</h3><div>We use data from the first nationally representative web survey of U.S. fertility, fielded in 2020–2022: the American Family Health Study (AFHS). Using responses from 1357 female-identifying respondents ages 18–49, we analyze 26,274 person-months of sex and contraceptive use data spanning directly before and after the beginning of the pandemic to detect change.</div></div><div><h3>Results</h3><div>Individual-level hazard models of starting and stopping contraception revealed no pandemic-related changes in starting contraception, but significant reductions in the rate of stopping contraception for specific subgroups. Hispanic females reduced their rates of stopping contraceptive use during the pandemic (lowering their odds of stopping use by 71%), ultimately behaving more similarly to individuals from other racial or ethnic subgroups. Additionally, those aged 41 and older significantly reduced their rates of stopping contraceptive use (lowering their odds of stopping use by 78%) relative to other age groups.</div></div><div><h3>Conclusions</h3><div>Sudden large-scale health policy changes can produce significant changes in contraceptive use behaviors. The COVID-19 changes interacted with race, ethnicity, and age to produce different changes in contraceptive behaviors among different subgroups of the U.S. population.</div></div>","PeriodicalId":10762,"journal":{"name":"Contraception","volume":"142 ","pages":"Article 110723"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142378714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.contraception.2024.110753
Yuyan Li , Yan Zhang , Dong Yuan , Li Shan , Xiaojing Dong , Liqun Wang , Yuanzhong Zhou , Weixin Liu , Xiaojun Wang , Lifang Jiang , Xiaoyu Hu , Wei Xia , Xiaochen Huang , Jiandong Song , Liangping Wang , Li Jiang , Hanfeng Ye , Yanfei Zhou , Yan Che
Objectives
This study aimed to evaluate the effects of a multilevel promoting postpartum family planning (PPFP) intervention on the reduction of unintended pregnancies and induced abortions in China.
Study design
We performed a cluster randomized intervention study to assess the effects of a multilevel PPFP intervention on the rates of unintended pregnancy and induced abortion within 12 months postpartum. Thirty-six hospitals were included and randomly allocated to two groups at a 1:1 ratio, enrolling 180 pregnant women per hospital starting in January 2019. The intervention included integrated contraceptive education and counseling at three critical stages, namely, the third trimester, delivery, and several postpartum time points. We used life table and multilevel Cox regression for data analysis.
Results
We recruited 6315 participants, namely, 3116 in the intervention group and 3199 in the control group. The 12-month cumulative rates of unintended pregnancy and induced abortion were significantly lower in the intervention group (2.74% [95% CI, 2.16–3.46] and 1.43% [95% CI, 1.01–2.03], respectively) than in the control group (6.99% [95% CI, 6.00–8.14] and 3.85% [95% CI, 3.09–4.79], respectively). Multilevel Cox regression revealed a 63% reduction in the risk of unintended pregnancy (hazard ratio 0.37 [95% CI, 0.19–0.71]) and a 66% reduction in the risk of induced abortion (hazard ratio 0.34 [95% CI, 0.16–0.69]) in the intervention group.
Conclusions
This multilevel PPFP intervention was effective in reducing the risk of unintended pregnancy and induced abortion within the first year after childbirth. We recommend scaling up this approach to other hospitals across the country that provide prenatal educational classes and postpartum contraceptive services.
Implications
Multifaceted PPFP interventions, which encompass contraceptive education during both pregnancy and the postpartum period, are effective in reducing unintended pregnancy rates in China. This strategy could be adopted in other similar health care settings worldwide.
{"title":"Effects of multilevel postpartum family planning intervention on the reduction of unintended pregnancy and induced abortion rates within 12 months of delivery: A cluster randomized controlled study in China","authors":"Yuyan Li , Yan Zhang , Dong Yuan , Li Shan , Xiaojing Dong , Liqun Wang , Yuanzhong Zhou , Weixin Liu , Xiaojun Wang , Lifang Jiang , Xiaoyu Hu , Wei Xia , Xiaochen Huang , Jiandong Song , Liangping Wang , Li Jiang , Hanfeng Ye , Yanfei Zhou , Yan Che","doi":"10.1016/j.contraception.2024.110753","DOIUrl":"10.1016/j.contraception.2024.110753","url":null,"abstract":"<div><h3>Objectives</h3><div>This study aimed to evaluate the effects of a multilevel promoting postpartum family planning (PPFP) intervention on the reduction of unintended pregnancies and induced abortions in China.</div></div><div><h3>Study design</h3><div>We performed a cluster randomized intervention study to assess the effects of a multilevel PPFP intervention on the rates of unintended pregnancy and induced abortion within 12 months postpartum. Thirty-six hospitals were included and randomly allocated to two groups at a 1:1 ratio, enrolling 180 pregnant women per hospital starting in January 2019. The intervention included integrated contraceptive education and counseling at three critical stages, namely, the third trimester, delivery, and several postpartum time points. We used life table and multilevel Cox regression for data analysis.</div></div><div><h3>Results</h3><div>We recruited 6315 participants, namely, 3116 in the intervention group and 3199 in the control group. The 12-month cumulative rates of unintended pregnancy and induced abortion were significantly lower in the intervention group (2.74% [95% CI, 2.16–3.46] and 1.43% [95% CI, 1.01–2.03], respectively) than in the control group (6.99% [95% CI, 6.00–8.14] and 3.85% [95% CI, 3.09–4.79], respectively). Multilevel Cox regression revealed a 63% reduction in the risk of unintended pregnancy (hazard ratio 0.37 [95% CI, 0.19–0.71]) and a 66% reduction in the risk of induced abortion (hazard ratio 0.34 [95% CI, 0.16–0.69]) in the intervention group.</div></div><div><h3>Conclusions</h3><div>This multilevel PPFP intervention was effective in reducing the risk of unintended pregnancy and induced abortion within the first year after childbirth. We recommend scaling up this approach to other hospitals across the country that provide prenatal educational classes and postpartum contraceptive services.</div></div><div><h3>Implications</h3><div>Multifaceted PPFP interventions, which encompass contraceptive education during both pregnancy and the postpartum period, are effective in reducing unintended pregnancy rates in China. This strategy could be adopted in other similar health care settings worldwide.</div></div><div><h3>Clinical Trials</h3><div>ChiCTR1900023790</div></div>","PeriodicalId":10762,"journal":{"name":"Contraception","volume":"142 ","pages":"Article 110753"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142678006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.contraception.2024.110726
Maria F. Gallo , Fernanda L. Schumacher , Megan Lawley , Sarah A. Keim , Amy C. Dupper , Lisa Keder
Objectives
We evaluated the effect of immediate postpartum use of depot medroxyprogesterone acetate (DMPA) on the timing of lactogenesis stage II (LS-II).
Study design
The initial design randomly assigned adults who delivered a full-term infant in 2019–2021 to receive within 48 hours of delivery: (1) DMPA, (2) placebo injection, or (3) no injection. Due to low enrollment, we changed in 2021–2023 to a nonrandomized design using matching at recruitment for obesity and delivery method and propensity score weighting for analysis. We combined data from both designs to compare immediate postpartum DMPA use (N = 55) vs control (placebo or no injection) group (N = 95). We defined noninferiority a priori as being met if the upper bound of a two-sided 95% CI for mean difference in time to LS-II between groups was <6 hours.
Results
The unweighted mean time to LS-II was 57.8 hours in the DMPA group (SD, 29.4) and 64.1 hours in the control group (SD, 36.1). Using propensity score weighting to make the groups comparable with respect to age, race, delivery method, and previous live births, the mean time to LS-II was 5.5 hours shorter (95% CI, −16.4, 5.5) for women in the DMPA relative to control group.
Conclusions
We found no evidence that DMPA use inhibits the onset of LS-II. Findings support immediate postpartum DMPA initiation among those intending to engage in human milk feeding.
Implications
A controlled trial (N = 150) did not detect any difference in time to lactogenesis stage II (“milk let-down”) between injectable contraception use within the first 48 hours postpartum and those without this exposure.
{"title":"Potential effect of immediate postpartum use of injectable contraception on lactogenesis","authors":"Maria F. Gallo , Fernanda L. Schumacher , Megan Lawley , Sarah A. Keim , Amy C. Dupper , Lisa Keder","doi":"10.1016/j.contraception.2024.110726","DOIUrl":"10.1016/j.contraception.2024.110726","url":null,"abstract":"<div><h3>Objectives</h3><div>We evaluated the effect of immediate postpartum use of depot medroxyprogesterone acetate (DMPA) on the timing of lactogenesis stage II (LS-II).</div></div><div><h3>Study design</h3><div>The initial design randomly assigned adults who delivered a full-term infant in 2019–2021 to receive within 48 hours of delivery: (1) DMPA, (2) placebo injection, or (3) no injection. Due to low enrollment, we changed in 2021–2023 to a nonrandomized design using matching at recruitment for obesity and delivery method and propensity score weighting for analysis. We combined data from both designs to compare immediate postpartum DMPA use (<em>N</em> = 55) vs control (placebo or no injection) group (<em>N</em> = 95). We defined noninferiority a priori as being met if the upper bound of a two-sided 95% CI for mean difference in time to LS-II between groups was <6 hours.</div></div><div><h3>Results</h3><div>The unweighted mean time to LS-II was 57.8 hours in the DMPA group (SD, 29.4) and 64.1 hours in the control group (SD, 36.1). Using propensity score weighting to make the groups comparable with respect to age, race, delivery method, and previous live births, the mean time to LS-II was 5.5 hours shorter (95% CI, −16.4, 5.5) for women in the DMPA relative to control group.</div></div><div><h3>Conclusions</h3><div>We found no evidence that DMPA use inhibits the onset of LS-II. Findings support immediate postpartum DMPA initiation among those intending to engage in human milk feeding.</div></div><div><h3>Implications</h3><div>A controlled trial (<em>N</em> = 150) did not detect any difference in time to lactogenesis stage II (“milk let-down”) between injectable contraception use within the first 48 hours postpartum and those without this exposure.</div></div>","PeriodicalId":10762,"journal":{"name":"Contraception","volume":"142 ","pages":"Article 110726"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11725434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142483227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.contraception.2024.110736
Nicole Quinones , Liza Fuentes , Asha Hassan , Anna K. Hing , Goleen Samari , Monica McLemore
{"title":"Corrigendum to Society of Family Planning Research Practice Support: Strategies and considerations for addressing race and racism in quantitative family planning studies [Contraception vol 139 (2024) 110534]","authors":"Nicole Quinones , Liza Fuentes , Asha Hassan , Anna K. Hing , Goleen Samari , Monica McLemore","doi":"10.1016/j.contraception.2024.110736","DOIUrl":"10.1016/j.contraception.2024.110736","url":null,"abstract":"","PeriodicalId":10762,"journal":{"name":"Contraception","volume":"142 ","pages":"Article 110736"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142633666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}