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埃及剖宫产术后产妇胎盘娩出后与产褥期放置宫内节育器的 1 年随机对照试验。

Post-placental intrauterine device insertion vs puerperal insertion in women undergoing caesarean delivery in Egypt: a 1 year randomised controlled trial.

机构信息

Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt.

出版信息

Eur J Contracept Reprod Health Care. 2020 Dec;25(6):439-444. doi: 10.1080/13625187.2020.1823366. Epub 2020 Oct 2.

Abstract

OBJECTIVE

The aim of the study was to compare 6 month expulsion rates of the copper-bearing intrauterine device (IUD) inserted after delivery of the placenta or at the 6 week postpartum visit in women undergoing caesarean section.

METHODS

A parallel-group randomised trial was conducted in an Egyptian university hospital between February 2016 and December 2018. Participants were randomised to either post-placental IUD insertion or IUD insertion at the 6 week postpartum visit. Participants were followed for 12 months. Primary outcomes were IUD expulsion and the proportion of women using an IUD at 6 months. A secondary outcome was the cumulative pregnancy rate at 12 months.

RESULTS

Five hundred participants were enrolled in each group. At 6 months the total expulsions were 58/416 (13.9%) in the post-placental group and 4/214 (1.9%) in the puerperal group; IUD use at 6 months was 416/478 (87.0%) in the post-placental group and 214/232 (92.2%) in the puerperal group. Data collected by phone at 12 months showed a higher cumulative pregnancy rate in the puerperal group (84/500, 16.8%) vs the post-placental group (22/500, 4.4%). IUD continuation at 12 months was higher in the post-placental group.

CONCLUSION

Participants in the post-placental group had a higher expulsion rate at 6 months, but more IUDs were placed in this group and fewer pregnancies had occurred at 12 months compared with the puerperal group.

TRIAL REGISTRATION

Clinicaltrials.gov NCT02679820.

摘要

目的

本研究旨在比较胎盘娩出后即刻与产后 6 周行剖宫产时放置含铜宫内节育器(IUD)的 6 个月脱落率。

方法

本平行分组随机对照试验于 2016 年 2 月至 2018 年 12 月在埃及一所大学医院进行。参与者被随机分为胎盘娩出后即刻放置 IUD 组或产后 6 周放置 IUD 组。参与者随访 12 个月。主要结局为 IUD 脱落率和产后 6 个月时使用 IUD 的妇女比例。次要结局为 12 个月时的累积妊娠率。

结果

每组纳入 500 名参与者。产后 6 个月时,胎盘娩出后即刻放置 IUD 组的总脱落率为 58/416(13.9%),产后 6 周放置 IUD 组为 4/214(1.9%);胎盘娩出后即刻放置 IUD 组产后 6 个月时 IUD 使用率为 416/478(87.0%),产后 6 周放置 IUD 组为 214/232(92.2%)。产后 12 个月时通过电话收集的数据显示,产后 6 周放置 IUD 组的累积妊娠率较高(84/500,16.8%),而胎盘娩出后即刻放置 IUD 组为 22/500(4.4%)。产后 12 个月时,胎盘娩出后即刻放置 IUD 组的 IUD 续用率更高。

结论

胎盘娩出后即刻放置 IUD 组的 6 个月脱落率较高,但与产后 6 周放置 IUD 组相比,该组放置的 IUD 更多,12 个月时发生的妊娠更少。

试验注册

Clinicaltrials.gov NCT02679820。

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