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孕早期人工流产时放置宫内节育器可减少重复流产的需求:一项随机对照试验的第一年结果

Provision of intrauterine contraception in association with first trimester induced abortion reduces the need of repeat abortion: first-year results of a randomized controlled trial.

作者信息

Pohjoranta Elina, Mentula Maarit, Gissler Mika, Suhonen Satu, Heikinheimo Oskari

机构信息

Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, Kätilöopisto Hospital, PO Box 610, Helsinki 00029-HUS, Finland.

National Institute for Health and Welfare, Helsinki, Finland.

出版信息

Hum Reprod. 2015 Nov;30(11):2539-46. doi: 10.1093/humrep/dev233. Epub 2015 Sep 14.

Abstract

STUDY QUESTION

Can the need of subsequent abortion be reduced by providing intrauterine contraception as a part of the abortion service?

SUMMARY ANSWER

Provision of intrauterine devices (IUDs) in association with first trimester abortion more than halved the incidence of repeat abortion during the first year of follow-up.

WHAT IS KNOWN ALREADY

Following abortion, the incidence of subsequent abortion is high, up to 30-40%. In cohort studies, intrauterine contraception has reduced the need of repeat abortion by 60-70%.

STUDY DESIGN, SIZE, DURATION: A randomized controlled trial. The main outcome measure was the incidence of subsequent induced abortions during the follow-up. Altogether 751 women seeking first trimester induced abortion were recruited and randomized into two groups. Randomization was accomplished by computer-assisted permuted-block randomization with random block sizes of four to six. The investigators did not participate in randomization, which was done before commencing the study. The participants were recruited between 18 October 2010 and 21 January 2013.

PARTICIPANTS, SETTINGS, METHODS: The inclusion criteria were age ≥18 years, duration of pregnancy ≤12 weeks, accepting intrauterine contraception, residence in Helsinki and signing the informed consent form. Women with contraindications to intrauterine contraception, such as uterine anomaly, acute genital infection or pap-smear change requiring surgical treatment were ineligible to participate.This study was conducted in collaboration between the Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, and Centralized family planning of the City of Helsinki.The intervention group (n = 375) was provided with intrauterine contraception (either the levonorgestrel-releasing intrauterine system or copper-releasing intrauterine device) immediately following surgical abortion (18.1%) or at a follow-up 2-4 weeks after medical abortion (81.9%). Women in the control group were prescribed oral contraceptives and advised to contact their primary healthcare unit for a follow-up visit and further contraceptive services according to national guidelines. The women were followed-up to 28 February 2014 by using the Finnish National Abortion Registry, Helsinki University Hospital electronic database and clinical follow-up visit at 1 year.

MAIN RESULTS AND THE ROLE OF CHANCE

The median age of the whole study group was 27 years and 44% had a history of induced abortion(s). During the follow-up year the number of women requesting subsequent abortion was significantly lower in the intervention than in the control group (9/375 [2.4%] versus 20/373 [5.4%], difference -3.0 [95% CI -6.0 to -0.2] percentage points, P = 0.038, according to intention-to-treat analysis and 5/346 [1.4%] versus 20/357 [5.6%], difference -4.2(-7.2 to -1.4) percentage points, P = 0.003, according to per-protocol analysis, respectively). Provision of intrauterine contraception was safe with rate of infection and expulsion similar to those reported previously.

LIMITATIONS, REASONS FOR CAUTION: The power calculation was calculated for a 5-year follow-up. However, significant differences between the two groups were already seen after 1 year. The present study was performed in a single clinic, where, ∼15% of all abortions in Finland are performed.

WIDER IMPLICATIONS OF THE FINDINGS

In order to decrease the need of subsequent abortions, IUDs should be provided at the time of abortion.

TRIAL REGISTRATION

The study was registered at www.clinicaltrials.gov (NCT01223521).

TRIAL REGISTRATION DATE

18 October 2010.

DATE OF FIRST PATIENT'S ENROLMENT: 18 October 2010.

摘要

研究问题

作为流产服务的一部分提供宫内避孕能否减少后续流产的需求?

简要回答

在孕早期流产时同时放置宫内节育器(IUD),使随访第一年重复流产的发生率减半以上。

已知信息

流产后,后续流产的发生率很高,可达30%-40%。在队列研究中,宫内避孕使重复流产的需求减少了60%-70%。

研究设计、规模、持续时间:一项随机对照试验。主要结局指标是随访期间后续人工流产的发生率。共招募了751名寻求孕早期人工流产的女性,并随机分为两组。随机分组通过计算机辅助的置换区组随机化完成,随机区组大小为4至6。研究人员不参与随机分组,随机分组在研究开始前进行。参与者于2010年10月18日至2013年1月21日招募。

参与者、研究地点、方法:纳入标准为年龄≥18岁、妊娠持续时间≤12周、接受宫内避孕、居住在赫尔辛基并签署知情同意书。有宫内避孕禁忌证的女性,如子宫异常、急性生殖器感染或巴氏涂片检查结果改变需要手术治疗的,不符合参与条件。本研究由赫尔辛基大学妇产科系、赫尔辛基大学医院和赫尔辛基市集中计划生育部门合作开展。干预组(n = 375)在手术流产后立即(18.1%)或药物流产后2-4周随访时(81.9%)放置宫内避孕器(左炔诺孕酮宫内缓释系统或含铜宫内节育器)。对照组女性开具口服避孕药,并建议根据国家指南联系其初级医疗保健单位进行随访和进一步的避孕服务。通过芬兰国家流产登记处、赫尔辛基大学医院电子数据库和1年时的临床随访对女性进行随访至2014年2月28日。

主要结果及偶然性的作用

整个研究组的中位年龄为27岁,44%有过人工流产史。在随访的一年中,干预组中要求后续流产的女性人数显著低于对照组(根据意向性分析,9/375[2.4%]对20/373[5.4%],差异-3.0[95%CI-6.0至-0.2]个百分点,P = 0.038;根据符合方案分析,分别为5/346[1.4%]对20/357[5.6%],差异-4.2(-7.2至-1.4)个百分点,P = 0.003)。放置宫内避孕器是安全的,感染和排出率与先前报道的相似。

局限性、谨慎的原因:功效计算是针对5年随访进行的。然而,两组之间在1年后就已经出现了显著差异。本研究在一个单一诊所进行,芬兰约15%的流产手术在此进行。

研究结果的更广泛影响

为了减少后续流产的需求,应在流产时放置宫内节育器。

试验注册

该研究在www.clinicaltrials.gov注册(NCT01223521)。

试验注册日期

2010年10月18日。

首例患者入组日期

2010年10月18日。

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