Antenatal couples' counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial.
Antenatal couples' counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial.
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产前夫妇在乌干达（ACCU）的咨询：一项随机对照可行性试验的研究方案。
DOI：
10.1186/s40814-022-01049-5
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发表时间：
2022-04-29
影响因子：
1.7
通讯作者：
Willcox ML
中科院分区：
文献类型：
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作者：
Mubangizi V;McGrath N;Kabakyenga JK;Muller I;Stuart BL;Raftery JP;Natukunda S;Ngonzi J;Goodhart C;Willcox ML
导致孕产妇、围产期和新生儿死亡的常见可避免因素包括缺乏生育计划（以及在不适当的地点分娩）和避孕需求未得到满足。进展缓慢，因为常规产前保健只关注妇女。然而，在乌干达，许多妇女首先要得到丈夫的认可。世界卫生组织建议产后计划生育（PPFP）作为保健的一个重要组成部分。这项试验的目的是测试在一项复杂的社区干预试验中招募和留住参与者的可行性，该试验旨在为乌干达的产前夫妇提供咨询。这是一项复杂干预的两组、非盲群随机对照可行性试验。乌干达的初级保健中心将被随机分配，接受卫生部提供的干预或常规护理。干预措施包括培训村卫生队，以便在家中向夫妇提供基本咨询，鼓励男子陪同妻子到产前诊所就诊；其次，培训保健工作者，以便在产前诊所向夫妇提供信息和咨询，促进共同决定最适当的分娩地点和产后避孕。我们的目标是在每个地区招募2个保健中心，每个中心有10个村卫生队，每个村卫生队的目标是招募35名孕妇（每个地区总共有700名妇女）。村卫生队将跟踪和收集社区孕妇分娩后12个月的数据，并将使用智能手机上的COSMOS软件直接输入数据。这一干预措施解决了孕产妇、围产期和新生儿死亡中两个可避免的关键因素（缺乏计划生育和分娩地点不当）。在本研究中确定产前夫妇咨询的可接受性和可行性将为完全随机对照临床试验的设计提供信息。如果这项试验证明招募和分娩的可行性，我们将寻求资金，开展一项全面的综合干预试验，以提高乌干达对生育计划和产后计划生育的接受程度。泛非临床试验注册中心PACTR202102794681952。于2021年2月10日批准。ISRCTN注册表ISRCTN97229911。在线注册于2021年9月23日，包含补充材料，可在10.1186/s40814-022-01049-5获得。
Common avoidable factors leading to maternal, perinatal and neonatal deaths include lack of birth planning (and delivery in an inappropriate place) and unmet need for contraception. Progress has been slow because routine antenatal care has focused only on women. Yet, in Uganda, many women first want the approval of their husbands. The World Health Organization recommends postpartum family planning (PPFP) as a critical component of health care. The aim of this trial is to test the feasibility of recruiting and retaining participants in a trial of a complex community-based intervention to provide counselling to antenatal couples in Uganda. This is a two-group, non-blinded cluster-randomised controlled feasibility trial of a complex intervention. Primary health centres in Uganda will be randomised to receive the intervention or usual care provided by the Ministry of Health. The intervention consists of training village health teams to provide basic counselling to couples at home, encouraging men to accompany their wives to an antenatal clinic, and secondly of training health workers to provide information and counselling to couples at antenatal clinics, to facilitate shared decision-making on the most appropriate place of delivery, and postpartum contraception. We aim to recruit 2 health centres in each arm, each with 10 village health teams, each of whom will aim to recruit 35 pregnant women (a total of 700 women per arm). The village health teams will follow up and collect data on pregnant women in the community up to 12 months after delivery and will directly enter the data using the COSMOS software on a smartphone. This intervention addresses two key avoidable factors in maternal, perinatal and neonatal deaths (lack of family planning and inappropriate place of delivery). Determining the acceptability and feasibility of antenatal couples’ counselling in this study will inform the design of a fully randomised controlled clinical trial. If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding to conduct a fully powered trial of the complex intervention for improving uptake of birth planning and postpartum family planning in Uganda. Pan African Clinical Trials Registry PACTR202102794681952. Approved on 10 February 2021. ISRCTN Registry ISRCTN97229911. Registered on 23 September 2021 The online version contains supplementary material available at 10.1186/s40814-022-01049-5.