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临床试验/NCT06666036
NCT06666036已完成不适用

Leveraging and Strengthening Local Systems to Increase First-time Mothers' Use of Postpartum Family Planning and Improve Postnatal Care in Bangladesh: A Cluster Randomized Controlled Trial

George Washington University1 个研究点 分布在 1 个国家目标入组 2,308 人开始时间: 2023年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,308
试验地点
1
主要终点
Adoption of Postpartum Family Planning (PPFP):

研究概览

简要总结

While a growing body of programs have shown promise to increase uptake of contraception among FTMs, difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Despite the importance of PNC it remains a neglected area within the maternal and newborn health continuum of care in many areas around the world. Programs working to improve coverage of PNC and PNHVs have faced difficulties with insufficient human resources and health systems, suggesting a need for prioritization of care in settings with limited human resources. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing PPFP and PNC uptake among FTMs. The investigators will evaluate Connect's approach through a cluster randomized control trial.

详细描述

While a growing body of programs have shown promise to increase uptake of contraception among FTMs, difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Despite the importance of PNC it remains a neglected area within the maternal and newborn health continuum of care in many areas around the world. Programs working to improve coverage of PNC and PNHVs have faced difficulties with insufficient human resources and health systems, suggesting a need for prioritization of care in settings with limited human resources. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing PPFP and PNC uptake among FTMs. The investigators will evaluate Connect's approach through a cluster randomized control trial.

The overall goal of this study is to add to the evidence base on scalable and efficacious approaches for increasing PPFP adoption and improving timing and uptake of PNC among adolescent and young FTMs in order to increase spacing before subsequent births and improve maternal and neonatal outcomes.

Specifically, this protocol outlines the parameters for the evaluation of the impact of Connect's package of community-level interventions-or "enhancements"-on adoption and continued use of modern PPFP methods and uptake of PNC among adolescent (ages 15-19 years) and young (ages 20-24 years) FTMs. These interventions are enhanced home visits by family welfare assistants (FWA) and FWA-led enhanced courtyard meetings.

FWA enhanced home visits are targeted based on identification of at-risk mother-baby dyads through a risk-stratification algorithm to ensure home visits to all FTMs who give birth at home and to at-risk mothers, including first time mothers. FWAs performing the enhanced home visits have undergone additional training emphasizing the importance of referring mothers to facility-based providers, encouraging facility delivery, encouraging attendance of courtyard meetings, involving other family members during the visit, and on the specific needs of first-time parents. Invitation cards to go to the nearest facility and mother-baby booklets within formaiton on ANC, PNC, AND PPFP are also provided.

Enhanced courtyard meetings include standard content provided across all locations but Connect reinforces the regularity of these meetings and the FWAs running them will be more sensitized to first-time parents.

研究设计

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

入排标准

年龄范围
14 Years 至 25 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant or has child under 5 months
  • Aged 14-25

排除标准

  • Younger than 14 or over 25
  • Has more than one child or is pregnant and has a child

研究组 & 干预措施

Connect Community Level Enhancements

Experimental

At the community level, Connect enhancements build on standard community health worker (CHW) home visits implemented by the government and pre-existing courtyard meetings implemented by the Government of Bangladesh.

Courtyard meetings are led by CHWs and convened monthly for new mothers and their families. CHWs sensitize participants to postpartum family planning (PPFP) and share the importance of available services from facilities. Connect reinforces the regularity of these meetings. CHWs receive additional training to be sensitized to the needs of first time parents and engage first-time mothers to attend.

Home Visits: CHWs conduct home visits to women who are pregnant or recently gave birth in their catchment areas. During these visits CHWs provide basic care, information on ANC, PNC and PPFP, and provide access to FP methods. Connect targets home visits to first time mothers and those who gave birth at home. They provide print materials to support PPFP and PNC care.

干预措施: Connect (Behavioral)

Control

No Intervention

No additional Connect intervention. Pre-existing institutionalized services for expecting and new mothers.

结局指标

主要结局

Adoption of Postpartum Family Planning (PPFP):

时间窗: 12 months

1\. Indicator for adopted a modern contraceptive method within 12 months after giving birth (among women who have given birth). Adoption of a modern contraceptive method in the first year after giving birth, among FTMs who have given birth-modern methods are defined here as male condoms, oral contraceptive pills, injectables, and long-active reversible contraception (LARC) methods (implants and intrauterine device (IUD)).

Currently using PPFP

时间窗: 12 months

2\. Currently using a modern contraceptive method (among women who have given birth). Modern methods are defined here as male condoms, oral contraceptive pills, injectables, and long-active reversible contraception (LARC) methods (implants and intrauterine device (IUD)).

Postnatal Care uptake

时间窗: 12 months

3\. Indicator for received any PNC, among FTMs who have given birth. Uptake of facility-based PNC for mother and baby. Care that is reported to be a PNC visit but occurs outside of a health facility is not considered a PNC visit for these indicators.

Timing of Postnatal Care (PNC)

时间窗: 12 months

4\. FTM received PNC within 72 hours of delivery, among FTMs who have given birth more than 72 hours ago. Care that is reported to be a PNC visit but occurs outside of a health facility is not considered a PNC visit for these indicators.

次要结局

  • Adopted or Intention to adopt PPFP(12 months)
  • Quality of additional PNC(12 months)
  • Quality of early PNC(12 months)
  • Contraceptive Preferences(12 months)
  • Quality of Family Planning Counselling(12 months)
  • Communication and agency(12 months)
  • PPFP knowledge(12 months)
  • PPFP Attitudes(12 months)
  • PNC attitudes(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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