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临床试验/NCT05280951
NCT05280951Unknown不适用

Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana

University of Notre Dame4 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2022年2月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
192
试验地点
4
主要终点
Number of Post-Birth Warning Signs Identified Per Participant

研究概览

简要总结

The purpose of this project is to test and evaluate an innovative postpartum care, education, and support model that integrates recommended clinical care, education, and support for women in a group setting.

Aim 1. Develop an innovative integrated group postpartum care, education, and support model entitled Focused-PPC for postpartum women up to one year after delivery.

Aim 2. Implement and evaluate this integrated postpartum care model entitled Focused-PPC in a parallel randomized controlled trial with 192 postpartum women at 4 health centers in Tamale, Ghana.

详细描述

Although the postpartum period poses substantial risks and can result in significant maternal morbidity and mortality, it receives much less attention than pregnancy and childbirth. Appropriate postpartum care enables healthcare providers identify and treat postpartum complications promptly, offer help with a wide range of health and social needs and encourage mothers to adopt evidenced-based postpartum practices at home, since maternal self-care usually takes place at home. In many settings in Sub-Saharan Africa, quality postpartum care, education, and support for the mother are often the missing components of postnatal care delivery, which focuses on care of the baby. The lack of standard postpartum care for the mother contributes to maternal deaths. There is an urgent need for an integrated postpartum care delivery model that is comprehensive and meets clinical care, education, and support needs of mothers. Thus, the purpose of this project is to test and evaluate an innovative postpartum care, education, and support model known as Focused-PPC, in Tamale, Ghana. The proposed project will be the first of its kind to design an integrated and comprehensive group postpartum care delivery model, focused on clinical care of the mother and baby, as well as education and peer support in Ghana. Our model supports the clinical assessments and timeframes recommended by the World Health Organization and adopted by Ghana Health Service. Together with my partner organization, Savana Signatures, we will develop and test Focused-PPC. Focused-PPC will be implemented in groups in health centers in Tamale, Ghana. Each group will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year postpartum following the Ghana health service postnatal care schedule. Led by trained midwives in the health centers, each group session will consist of postpartum clinical assessments for mother (in addition to baby), education, and support. Focused-PPC has the potential to change the postpartum care delivery model in Ghana and other countries in sub-Saharan Africa and beyond. Results from this implementation will be used to further refine and scale up the Focused-PPC model of postpartum care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Had a stillbirth

结局指标

主要结局

Number of Post-Birth Warning Signs Identified Per Participant

时间窗: 1 year

Knowledge of post-birth warning signs will be assessed using a question that asks participants to identify (check all that apply) warning signs of complications. Response options will include nine post-birth warning signs. Each item will be recorded as dichotomous, with a value of 1 assigned if the woman identified the warning sign and 0 if she did not. The total knowledge score will be the sum of these dichotomous items. The mean knowledge score will be calculated as the total knowledge score divided by 9 and reflect the percentage of warning signs known. We will model and test the between treatment and control group's knowledge of post-birth warning signs at each timepoint and between timepoints will be assessed using a repeated measure multivariate analysis of variance (MANOVA) with a time and treatment interaction will be run as the primary analysis controlling for baseline demographic variables.

次要结局

  • Postpartum Health Behaviors Practiced(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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