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铜 T380 宫内节育器用于紧急避孕:在月经周期的任何时间都非常有效。

Copper T380 intrauterine device for emergency contraception: highly effective at any time in the menstrual cycle.

机构信息

Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT 84132, USA.

出版信息

Hum Reprod. 2013 Oct;28(10):2672-6. doi: 10.1093/humrep/det330. Epub 2013 Aug 14.

DOI:10.1093/humrep/det330
PMID:23945595
Abstract

STUDY QUESTION

Does the efficacy of placing a copper intrauterine device (IUD) for emergency contraception (EC) to prevent pregnancy depend on menstrual cycle timing and timing of unprotected intercourse (UPI)?

SUMMARY ANSWER

If the urine pregnancy test is negative prior to IUD placement, the copper IUD is highly effective for EC at any point in the menstrual cycle.

WHAT IS KNOWN ALREADY

The use of the Copper T380A for EC has been encouraged by the failure of oral EC methods to decrease rates of unintended pregnancy and the documented success of the IUD in reducing unintended pregnancies. However scant data exist regarding the efficacy and safety of IUD insertion for EC when accounting for menstrual cycle timing and time since UPI.

STUDY DESIGN, SIZE, DURATION: This is a secondary analysis of data obtained from a previously published prospective cohort study of women who received the Copper T380A IUD for EC between July 1997 and January 2000. We included 1840 participants according to the study inclusion criteria of a known last menstrual period (LMP) and cycle lengths of 25-35 days.

PARTICIPANTS/MATERIALS, SETTING, METHODS: The original study included women aged between 18 and 44 years who presented for EC at 18 sites throughout China and who had regular menstrual cycles between 24 and 42 days, a known LMP, UPI within 120 h (5 days) and a negative urine pregnancy test (cutoff <25 IU/ml). Women with uncertain LMP dates were excluded. This study included only participants with cycle lengths of 25-35 days.

MAIN RESULTS AND THE ROLE OF CHANCE

Among the 1840 participants with usual cycle lengths of 25-35 days, 850 (46.2%) had their IUD inserted following UPI in the expected fertile window and 84 (4.6%) had the insertion >5 days after the predicted ovulation day and 52 (2.8%) had the insertion >5 days after UPI. There were no pregnancies in the first month among the 1771 women who had information available regarding their 1-month follow-up pregnancy test.

LIMITATIONS, REASONS FOR CAUTION: This was a secondary analysis of an observational study, and thus participants were not randomized to an alternative postcoital method. There were a small number of women who had UPI >5 days after their predicted ovulation day thus limiting the confidence of assuring a low risk of pregnancy in this situation. The ovulation day was calculated based on the LMP prior to IUD insertion and not on the subsequent first day of menses following IUD insertion.

WIDER IMPLICATIONS OF THE FINDINGS

If the urine pregnancy test is negative prior to IUD placement, the copper IUD is likely to be effective for EC at almost any point in the menstrual cycle.

STUDY FUNDING/COMPETING INTEREST(S): The original study was funded by the UNDP/UNPFA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. The donors and sponsors of the study had no role in the study design, data collection, data analysis, data interpretation, writing of the report or the decision to submit the paper for publication.

摘要

研究问题

放置含铜宫内节育器(IUD)进行紧急避孕(EC)以防止怀孕的效果是否取决于月经周期时间和无保护性行为(UPI)的时间?

总结答案

如果在放置 IUD 之前尿液妊娠试验呈阴性,则铜 IUD 在月经周期的任何时间点对 EC 都非常有效。

已知情况

口服 EC 方法未能降低意外怀孕率,以及 IUD 降低意外怀孕率的记录在案,这鼓励了使用铜 T380A 进行 EC。 然而,关于在考虑月经周期时间和 UPI 时间后,IUD 插入用于 EC 的疗效和安全性的数据很少。

研究设计、大小和持续时间:这是对先前发表的前瞻性队列研究数据的二次分析,该研究纳入了 1997 年 7 月至 2000 年 1 月期间因 EC 而接受铜 T380A IUD 的女性。我们根据研究纳入标准纳入了 1840 名参与者,即已知末次月经(LMP)和周期长度为 25-35 天。

参与者/材料、地点和方法:原始研究纳入了年龄在 18 至 44 岁之间的女性,她们在中国各地的 18 个地点因 EC 就诊,并且月经周期在 24 至 42 天之间,有已知的 LMP、UPI 在 120 小时(5 天)内和阴性尿液妊娠试验(<25 IU/ml)。排除不确定 LMP 日期的女性。本研究仅包括周期长度为 25-35 天的参与者。

主要结果和机会的作用

在 1840 名具有通常 25-35 天周期长度的参与者中,850 名(46.2%)在预期的可育窗口期内进行了 UPI 后的 IUD 插入,84 名(4.6%)在预测排卵日后>5 天进行了插入,52 名(2.8%)在 UPI 后>5 天进行了插入。在可获得 1 个月随访妊娠试验信息的 1771 名女性中,第一个月没有怀孕。

局限性、谨慎的原因:这是一项观察性研究的二次分析,因此参与者未被随机分配到替代的性交后方法。有一小部分女性在预测排卵日后>5 天进行 UPI,因此很难确保这种情况下怀孕的风险较低。排卵日是根据放置 IUD 前的 LMP 计算的,而不是根据放置 IUD 后首次月经的第一天计算的。

研究结果的更广泛意义

如果在放置 IUD 之前尿液妊娠试验呈阴性,则铜 IUD 在月经周期的几乎任何时间点都可能对 EC 有效。

研究资金/利益冲突:原始研究由联合国开发计划署/联合国人口基金/世界卫生组织/世界银行人类生殖特别方案、研究、开发和研究培训供资。该研究的捐助者和赞助商在研究设计、数据收集、数据分析、数据解释、报告撰写或提交论文供发表的决定方面没有任何作用。

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