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将避孕服务整合到现有的围产期保健中:中国上海基于社区的整群随机对照试验方案。

Integrating contraceptive services into existing perinatal care: protocol for a community-based cluster randomised controlled trial in Shanghai, China.

机构信息

Department of Woman Health Care, Minhang District Maternal and Child Health Hospital, Shanghai, China.

School of Public Health, Key Laboratory of Health Technology Assessment, Fudan University, Shanghai, China.

出版信息

BMJ Open. 2023 Mar 21;13(3):e066146. doi: 10.1136/bmjopen-2022-066146.

Abstract

INTRODUCTION

Postpartum contraception is essential to preventing unintended pregnancies and short interpregnancy intervals. The first year after childbirth is a critical period with a high risk of unintended pregnancy and induced abortion. However, the postpartum contraceptive services are weak in China's existing maternal and child healthcare system. We propose to evaluate the effects of integrating postpartum contraceptive services into the existing perinatal care system via a cluster randomised controlled trial.

METHODS AND ANALYSIS

This cluster randomised controlled trial involves all 13 communities of Minhang District, Shanghai, China. Communities will be randomly allocated, seven in the intervention group and six in the control group. One thousand and three hundred women, 100 women in each community, will be recruited in the study. Women assigned to the intervention group will receive postpartum contraceptive education and counselling during pregnancy, childbirth hospitalisation, postpartum home visits and the 42-day postpartum clinic check-up. Women in the control group will receive routine antenatal and postpartum care. Participants will be recruited in the first trimester during pregnancy and followed up to 1 year postpartum. The primary outcome is the incidence of unintended pregnancy within 1 year after childbirth.

ETHICS AND DISSEMINATION

The trial received ethical approval from the Ethics Committee of Shanghai Minhang District Maternal and Child Health Care Hospital (#[2020]KS-02, #[2020]KS-05, #[2020]KS-05-EX). Results will be published in academic journals and disseminated in multiple formats for the health professionals and the public.

TRIAL REGISTRATION NUMBER

ChiCTR2000034603.

摘要

简介

产后避孕对于避免意外怀孕和缩短妊娠间隔至关重要。产后第一年是一个关键时期,意外怀孕和人工流产的风险很高。然而,中国现有的母婴保健体系中,产后避孕服务薄弱。我们建议通过一项整群随机对照试验,评估将产后避孕服务纳入现有围产期保健系统的效果。

方法和分析

这项整群随机对照试验涉及中国上海市闵行区的 13 个社区。社区将被随机分配,其中 7 个社区为干预组,6 个社区为对照组。研究将招募 1300 名妇女,每个社区 100 名妇女。分配到干预组的妇女将在怀孕期间、分娩住院期间、产后家访和产后 42 天门诊检查时接受产后避孕教育和咨询。对照组的妇女将接受常规产前和产后护理。参与者将在妊娠早期招募,并随访至产后 1 年。主要结局是产后 1 年内意外怀孕的发生率。

伦理和传播

该试验已获得上海市闵行区妇幼保健院伦理委员会的批准([2020]KS-02、[2020]KS-05、[2020]KS-05-EX)。结果将发表在学术期刊上,并以多种形式传播给卫生专业人员和公众。

临床试验注册

ChiCTR2000034603。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a846/10032403/4ba8ac7b81ad/bmjopen-2022-066146f01.jpg

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