Maricianah Onono , Kavita Nanda , Kate B. Heller , Doug Taylor , Irina Yacobson , Renee Heffron , Margaret Phiri Kasaro , Cheryl E. Louw , Zelda Nhlabasti , Thesla Palanee-Phillips , Jenni Smit , Imelda Wakhungu , Peter B. Gichangi , Nelly R. Mugo , Charles Morrison , Jared M. Baeten , for the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial Consortium
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Baeten , for the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial Consortium","doi":"10.1016/j.conx.2020.100026","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>The objective was to address bias in contraception efficacy studies through a randomized study trial of intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUDs) and a levonorgestrel (LNG) implant.</p></div><div><h3>Study design</h3><p>We analyzed data from the Evidence for Contraceptive Options and HIV Outcomes Trial, which assessed HIV incidence among 7829 women from 12 sites in eSwatini, Kenya, South Africa and Zambia seeking effective contraception and who consented to be randomized to DMPA-IM, copper IUD or LNG implant. We used Cox proportional hazards regression adjusted for condom use to compare pregnancy incidence during both perfect and typical (i.e., allowing temporary interruptions) use.</p></div><div><h3>Results</h3><p>A total of 7710 women contributed to this analysis. Seventy pregnancies occurred during perfect and 85 during typical use. There was no statistically significant difference in perfect use pregnancy incidence among the methods: 0.61 per 100 woman-years for DMPA-IM [95% confidence interval (CI) 0.36–0.96], 1.06 for copper IUD (95% CI 0.72–1.50) and 0.63 for LNG implants (95% CI 0.39–0.96). Typical use pregnancy rates were also largely similar: 0.87 per 100 woman-years for DMPA-IM (95% CI 0.58–1.25), 1.11 for copper IUD (95% CI 0.77–1.54) and 0.63 for LNG implants (95% CI 0.39–0.96).</p></div><div><h3>Conclusions</h3><p>In this randomized trial of highly effective contraceptive methods among African women, both perfect and typical use resulted in low pregnancy rates. Our findings provide strong justification for improving access to a broader range of longer-acting contraceptive options including LNG implants and copper IUD for African women.</p></div><div><h3>Implications statement</h3><p>Data from this study support recommendations to providers, policy makers and patients that all of these methods provide safe and highly effective contraception for African women.</p></div>","PeriodicalId":10655,"journal":{"name":"Contraception: X","volume":"2 ","pages":"Article 100026"},"PeriodicalIF":0.0000,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.conx.2020.100026","citationCount":"1","resultStr":"{\"title\":\"Comparison of pregnancy incidence among African women in a randomized trial of intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUDs) or a levonorgestrel (LNG) implant for contraception\",\"authors\":\"Maricianah Onono , Kavita Nanda , Kate B. 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引用次数: 1
摘要
目的:通过一项肌肉内注射醋酸甲羟孕酮(DMPA-IM)、铜宫内节育器(iud)和左炔诺孕酮(LNG)植入物的随机研究试验，解决避孕疗效研究中的偏倚问题。研究设计:我们分析了避孕选择证据和HIV结局试验的数据，该试验评估了来自斯瓦蒂尼、肯尼亚、南非和赞比亚12个地点的7829名寻求有效避孕的妇女的HIV发病率，这些妇女同意随机分配到DMPA-IM、铜宫内节育器或LNG植入物。我们使用Cox比例风险回归对避孕套的使用进行调整，比较完美和典型(即允许暂时中断)使用期间的怀孕发生率。结果共有7710名女性参与了本分析。70例妊娠发生在完美妊娠期，85例发生在典型妊娠期。两种方法的完美使用妊娠发生率无统计学差异:DMPA-IM的发生率为0.61 / 100女性年[95%可信区间(CI) 0.36-0.96]，铜宫内节育器的发生率为1.06 (95% CI 0.72-1.50)， LNG植入物的发生率为0.63 (95% CI 0.39-0.96)。典型使用妊娠率也非常相似:DMPA-IM的0.87 / 100名妇女年(95% CI 0.58-1.25)，铜宫内节育器的1.11 (95% CI 0.77-1.54)和LNG植入物的0.63 (95% CI 0.39-0.96)。结论在非洲妇女中进行的一项高效避孕方法的随机试验中，完美和典型的使用都导致了低怀孕率。我们的研究结果为改善非洲妇女获得更广泛的长效避孕选择提供了强有力的理由，包括LNG植入物和铜宫内节育器。结论:本研究的数据支持向医疗服务提供者、政策制定者和患者提出的建议，即所有这些方法都为非洲妇女提供了安全、高效的避孕方法。
Comparison of pregnancy incidence among African women in a randomized trial of intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUDs) or a levonorgestrel (LNG) implant for contraception
Objective
The objective was to address bias in contraception efficacy studies through a randomized study trial of intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUDs) and a levonorgestrel (LNG) implant.
Study design
We analyzed data from the Evidence for Contraceptive Options and HIV Outcomes Trial, which assessed HIV incidence among 7829 women from 12 sites in eSwatini, Kenya, South Africa and Zambia seeking effective contraception and who consented to be randomized to DMPA-IM, copper IUD or LNG implant. We used Cox proportional hazards regression adjusted for condom use to compare pregnancy incidence during both perfect and typical (i.e., allowing temporary interruptions) use.
Results
A total of 7710 women contributed to this analysis. Seventy pregnancies occurred during perfect and 85 during typical use. There was no statistically significant difference in perfect use pregnancy incidence among the methods: 0.61 per 100 woman-years for DMPA-IM [95% confidence interval (CI) 0.36–0.96], 1.06 for copper IUD (95% CI 0.72–1.50) and 0.63 for LNG implants (95% CI 0.39–0.96). Typical use pregnancy rates were also largely similar: 0.87 per 100 woman-years for DMPA-IM (95% CI 0.58–1.25), 1.11 for copper IUD (95% CI 0.77–1.54) and 0.63 for LNG implants (95% CI 0.39–0.96).
Conclusions
In this randomized trial of highly effective contraceptive methods among African women, both perfect and typical use resulted in low pregnancy rates. Our findings provide strong justification for improving access to a broader range of longer-acting contraceptive options including LNG implants and copper IUD for African women.
Implications statement
Data from this study support recommendations to providers, policy makers and patients that all of these methods provide safe and highly effective contraception for African women.
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