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IF 2.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-03 DOI: 10.1016/S0010-7824(25)00011-3
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引用次数: 0
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 与含炔雌醇的避孕药相比,天然雌激素类药物的静脉血栓栓塞事件报告率较低:Eudravigilance 数据库的比例失调分析。
IF 2.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 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.
目标:药物警戒数据分析可加速识别药物相关的安全信号或保证药物的安全性。本研究利用 EudraVigilance 数据库中的数据,评估了含有天然雌激素(如雌二醇(E2)和雌三醇(E4))的新型 COC 制剂的 VTE 风险:我们从 EudraVigilance 数据库中提取了截至 2024 年 7 月 28 日的单个病例报告,对与各种 COC 制剂相关的 VTE 事件进行了比例失调报告率分析。研究比较了天然雌激素类化学合成药物(E2 和 E4)与传统合成雌激素类化学合成药物(EE)之间的比例报告率,并与 EE-左炔诺孕酮(EE-LNG)进行了比较:结果:分析表明,与基于 EE 的 COC 相比,含有天然雌激素的 COC 的血栓事件比例报告率明显较低。具体而言,E4-屈螺酮(E4-DRSP)的比例报告率最低(0.12),与纯孕激素药片相似。EE-屈螺酮(EE-DRSP)的比例报告率最高(2.25),表明血栓风险增加:该研究支持天然雌激素类药物(尤其是 E2 和 E4 配方)比含有 EE 的合成雌激素类药物更安全的血栓形成特征。这些发现支持了基于 E2 和 E4 的药片比基于 EE 的药片更安全的假设,这与临床实践中向更安全的避孕选择转变是一致的。
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引用次数: 0
Retail availability of over-the-counter birth control pills at Texas pharmacies: Results from a mystery caller study 德克萨斯州药店零售非处方避孕药的情况:神秘电话研究结果。
IF 2.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 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.
研究目的估算最近发布的非处方药(OTC)避孕药(Opill®)在零售药店的供应情况,并根据药店的连锁状况和环境对不同药店的供应情况进行比较:研究设计:2024 年 4 月和 5 月,我们对德克萨斯州的 500 家零售药店进行了神秘顾客调查。项目女性工作人员冒充潜在客户与抽样药店取得联系,询问他们是否有非处方药避孕药库存,如果没有,是否可以订购。我们根据连锁药店的状况(独立药店、零售店内的连锁药店、有独立店面的连锁药店)对药店进行了分类,并通过地理定位对位于农村或城市地区的药店进行了分类:总体而言,62% 的药店(477 家)报告有 Opill® 出售。不同类型的药房有不同的库存量,独立药房的库存量最少(25%),而独立连锁药房的库存量最多(82%)。在有 Opill® 库存或愿意订购 Opill® 的药房中,我们也发现了类似的模式。我们发现城市药房和农村药房之间没有明显差异:尽管 Opill® 上市时间不长(2024 年 3 月),但在得克萨斯州的零售药店中仍可广泛买到,不过独立药店的库存量较少。虽然不需要处方就能买到避孕药,但不同类型的药店提供的避孕药可能会有所不同。
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引用次数: 0
Success of medication abortion with mifepristone followed by two doses of misoprostol in very early pregnancy 在早孕期使用米非司酮后再使用两剂米索前列醇进行药物流产的成功案例。
IF 2.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 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.
目的:比较药物流产(MAB)在极早期妊娠(VEP)中的成功率:比较使用米非司酮后再使用一剂或两剂米索前列醇的药物流产(MAB)在极早期妊娠(VEP)中的成功率:研究设计:我们对 2021 年 1 月 7 日至 2022 年 5 月 31 日期间使用米非司酮 200 毫克口服并在 24-48 小时后使用单剂量米索前列醇 800 毫微克口服液的 VEP 药物流产病例和 2022 年 6 月 21 日至 2022 年 10 月 31 日期间使用米非司酮 200 毫克口服并在 4 小时内间隔使用两剂量米索前列醇 800 毫微克口服液的药物流产病例进行了回顾性队列分析,第一剂在米非司酮使用 24-48 小时后服用。在米非司酮治疗时采集血清 BhCG,在米索前列醇治疗后 48-72 小时再采集血清 BhCG。成功的定义是 BhCG 下降大于或等于 50%。米索前列醇治疗失败的定义是通过随访超声波检查或吸宫术进行程序性干预而确定的持续存活妊娠:单剂量米索前列醇组共有 423 名患者,双剂量米索前列醇组共有 262 名患者。两组患者的基线特征无明显差异。单剂量组中,372 例(87.9%)患者治疗成功;双剂量组中,224 例(85.5%)患者治疗成功。两组的 MAB 成功率无明显差异(P=0.73):临床试验注册号:临床试验注册号:不详。
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引用次数: 0
Suspected hepatotoxicity from etonogestrel contraceptive implant: A rare case report 艾托孕烯避孕植入物引起的疑似肝中毒:罕见病例报告
IF 2.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 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.
我们介绍了一例疑似依托孕烯避孕植入物继发肝中毒的病例,患者出现呕吐、黄疸、瘙痒、转氨酶升高和高胆红素血症。包括肝活检在内的大量检查结果均无异常。植入物被移除后,患者的症状和转氨酶升高缓解,这表明是药物引起的肝损伤。
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引用次数: 0
Comparison of etonogestrel bioanalytical assay results in plasma and serum within and across laboratories 血浆和血清中依托诺雌醇生物分析测定结果在实验室内和实验室间的比较。
IF 2.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 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.
研究目的研究设计:我们进行了一项盲法研究,共有六家实验室参加:五家学术实验室和一家签约商业实验室(参考实验室)。每个实验室都对制备的六种已知依托孕烯浓度的血清和/或血浆样本以及使用含依托孕烯避孕方法的参试者的 60 份临床样本进行了依托孕烯定量分析。根据监管指南,实验室准确度(偏差百分比)和精密度(变异系数;CV)定义为标称制备浓度的±15%。我们使用 Kendall's Tau-B 和 Passing-Bablok 回归法比较了实验室之间和实验室内部的一致性:结果:对于制备好的样本,6 个实验室分析了血清,3 个实验室分析了血浆。包括参比实验室在内的四家实验室所有依托孕烯浓度的准确度均在±15%以内。所有实验室的精确度都很高,只有一家实验室的 CV 值大于 15%。我们发现制备的血浆和血清中的依托孕烯结果之间存在正相关(Kendall's Tau-B 0.80-0.88)。对于临床样本,5 家实验室分析血清,3 家实验室分析血浆。与参比实验室相比,实验室间的血清依托孕烯浓度呈正相关(Kendall's Tau-B 0.76-0.95)。观察到了比例偏差,即单个实验室的依托孕烯结果始终高于(斜率估计值 0.78-0.95)或低于(斜率估计值 1.05-1.10)参照实验室。在临床样本中,血浆和血清之间的实验室内结果关联良好(Kendall's Tau-B 0.92-0.96):结论:无论样品基质如何,实验室内的一致性都很好;然而,依托孕烯结果在实验室间存在差异。在比较不同研究的依托孕烯药代动力学时,应考虑实验室结果之间的差异。
{"title":"Comparison of etonogestrel bioanalytical assay results in plasma and serum within and across laboratories","authors":"Shawnalyn W. Sunagawa ,&nbsp;Lee C. Winchester ,&nbsp;Christopher S. Wichman ,&nbsp;Sean N. Avedissian ,&nbsp;David W. Erikson ,&nbsp;Molly Kernan ,&nbsp;Mark A. Marzinke ,&nbsp;Timothy M. Mykris ,&nbsp;Renu Nandakumar ,&nbsp;Thomas D. Nolin ,&nbsp;Anthony T. Podany ,&nbsp;Raymond E. West III ,&nbsp;Beatrice A. Chen ,&nbsp;Catherine A. Chappell ,&nbsp;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 &gt;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}
引用次数: 0
Pandemic changes in U.S. contraceptive use: National survey estimates reveal significant differences by demographic subgroups 美国避孕药具使用的大流行变化:全国调查估算显示不同人口亚群之间存在显著差异。
IF 2.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 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.
目标:COVID-19 大流行同时带来了多种后果,极有可能改变与生育相关的行为。我们使用具有全国代表性的性别和避孕药具使用历史事件日历测量数据来展示大流行后避孕药具使用的特定个人变化,并显示不同人口亚群之间的差异:我们使用的数据来自 2020-2022 年开展的首次具有全国代表性的美国生育率网络调查:美国家庭健康研究(AFHS)。我们利用 1,357 名 18-49 岁女性受访者的回答,分析了大流行开始前后 26,274 人月的性生活和避孕药具使用数据,以检测变化情况:开始和停止避孕的个人水平危险模型显示,开始避孕的人数没有发生与大流行相关的变化,但特定亚群的停止避孕率显著下降。西班牙裔女性在大流行期间降低了停止使用避孕药具的比率(停止使用的几率降低了 71%),最终表现与其他种族或民族亚群的个人更为相似。此外,与其他年龄组相比,41 岁及以上的人群停止使用避孕药具的比例明显降低(停止使用的几率降低了 78%):结论:突如其来的大规模卫生政策变化会对避孕药具使用行为产生重大影响。COVID-19 的变化与种族、民族和年龄相互作用,在美国人口的不同亚群中产生了不同的避孕行为变化:
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引用次数: 0
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 多层次产后计划生育干预对降低产后12个月内意外怀孕率和人工流产率的影响:中国的一项分组随机对照研究。
IF 2.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 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.

Clinical Trials

ChiCTR1900023790
研究目的:评估中国多层次产后计划生育干预措施对减少意外怀孕和人工流产的影响:研究设计:研究设计:我们开展了一项分组随机干预研究,以评估多层次产后计划生育干预对产后 12 个月内意外怀孕率和人工流产率的影响。研究纳入了 36 家医院,并按 1:1 的比例随机分配到两组,从 2019 年 1 月开始,每家医院招募 180 名孕妇。干预措施包括三个关键阶段的综合避孕教育和咨询,即妊娠三个月、分娩和产后几个时间点。我们使用生命表和多层次考克斯回归进行数据分析:我们招募了 6315 名参与者,其中干预组 3116 人,对照组 3199 人。干预组的 12 个月累计意外怀孕率和人工流产率(分别为 2.74% [95% CI, 2.16-3.46] 和 1.43% [95% CI, 1.01-2.03])明显低于对照组(分别为 6.99% [95% CI, 6.00-8.14] 和 3.85% [95% CI, 3.09-4.79])。多层次考克斯回归显示,干预组的意外怀孕风险降低了 63%(HR 0.37 [95% CI, 0.19-0.71]),人工流产风险降低了 67%(HR 0.34 [95% CI, 0.16-0.69]):这种多层次的 PPFP 干预措施能有效降低产后第一年内意外怀孕和人工流产的风险。我们建议将这种方法推广到全国其他提供产前教育课程和产后避孕服务的医院:ChiCTR1900023790。
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引用次数: 0
Potential effect of immediate postpartum use of injectable contraception on lactogenesis 产后立即使用注射避孕药对泌乳的潜在影响。
IF 2.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 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.
研究目的我们评估了产后立即使用醋酸甲羟孕酮(DMPA)对泌乳期第二阶段(LS-II)时间的影响:最初的设计是随机分配在 2019-2021 年分娩足月婴儿的成人在分娩后 48 小时内接受:1)DMPA;2)安慰剂注射;或 3)不注射。由于注册人数较少,我们在 2021-2023 年改为非随机设计,在招募时对肥胖和分娩方式进行匹配,并采用倾向得分加权法进行分析。我们合并了两种设计的数据,对产后立即使用 DMPA 组(N=55)与对照组(安慰剂或不注射)(N=95)进行了比较。如果两组间 LS-II 平均差异时间的双侧 95% 置信区间 (CI) 上限为 "结果",我们就先验地将其定义为 "非劣效性":DMPA 组的 LS-II 非加权平均时间为 57.8 小时(标度为 29.4),对照组为 64.1 小时(标度为 36.1)。使用倾向得分加权法使各组在年龄、种族、分娩方式和既往活产情况方面具有可比性,DMPA 组妇女的 LS-II 平均时间比对照组缩短了 5.5 小时(95% CI,-16.4,5.5):结论:我们没有发现使用 DMPA 会抑制 LS-II 的发生。结论:我们没有发现使用 DMPA 会抑制 LS-II 的发生。研究结果支持那些打算母乳喂养的妇女在产后立即开始使用 DMPA:一项对照试验(N=150)未发现产后 48 小时内使用注射避孕药与未使用注射避孕药的产妇在泌乳期第二阶段("下奶")的时间上有任何差异。
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引用次数: 0
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] 计划生育研究实践支持学会:计划生育定量研究中处理种族和种族主义问题的策略和考虑[《避孕》第 139 卷(2024 年)110534]。
IF 2.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.contraception.2024.110736
Nicole Quinones , Liza Fuentes , Asha Hassan , Anna K. Hing , Goleen Samari , Monica McLemore
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期刊
Contraception
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