Mubangizi Vincent, McGrath Nuala, Kabakyenga Jerome Kahuma, Muller Ingrid, Stuart Beth L, Raftery James P, Natukunda Sylvia, Ngonzi Joseph, Goodhart Clare, Willcox Merlin Luke
Mbarara University of Science and Technology, P.O. Box 1410, Mbarara, Uganda.
School of Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
Pilot Feasibility Stud. 2022 Apr 29;8(1):97. doi: 10.1186/s40814-022-01049-5.
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.
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。进展一直缓慢，因为常规产前护理仅关注女性。然而，在乌干达，许多女性首先需要得到丈夫的认可。世界卫生组织建议将产后计划生育（PPFP）作为医疗保健的一个关键组成部分。本试验的目的是测试在一项基于社区的复杂干预试验中招募和留住参与者的可行性，该干预旨在为乌干达的产前夫妇提供咨询。
这是一项关于复杂干预的两组、非盲群随机对照可行性试验。乌干达的初级卫生保健中心将被随机分配接受干预或由卫生部提供的常规护理。干预措施包括培训乡村卫生团队在家中为夫妇提供基本咨询，鼓励男性陪同妻子前往产前诊所，其次是培训卫生工作者在产前诊所为夫妇提供信息和咨询，以促进就最合适的分娩地点和产后避孕进行共同决策。我们的目标是在每组中招募2个卫生中心，每个卫生中心有10个乡村卫生团队，每个团队的目标是招募35名孕妇（每组共700名女性）。乡村卫生团队将对社区中的孕妇进行随访并收集产后长达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。
该干预解决了孕产妇、围产期和新生儿死亡中的两个关键可避免因素（缺乏计划生育和不适当的分娩地点）。在本研究中确定产前夫妇咨询的可接受性和可行性将为全面随机对照临床试验的设计提供信息。如果该试验证明了招募和实施的可行性，我们将寻求资金开展一项充分有力的试验，以对该复杂干预措施进行测试，以提高乌干达生育计划和产后计划生育的接受率。
泛非临床试验注册中心PACTR202102794681952。于2021年2月10日批准。国际标准随机对照试验编号注册中心ISRCTN97229911。于2021年9月23日注册。
