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临床试验/NCT02309489
NCT02309489已完成不适用

Involving Men in Maternity Care in Burkina Faso

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 1,144 人开始时间: 2015年1月最近更新:
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
1,144
试验地点
1
主要终点
Number of Participants Attending the Recommended Number of Postnatal Care Appointments

研究概览

简要总结

The uptake of postpartum contraception, postpartum care attendance and the practice of exclusive breastfeeding are low in Sub-Saharan Africa. Although the involvement of men in maternity care has been shown to be a promising strategy for the achievement of other reproductive health goals, little is known about the effect of their participation on these outcomes. This study aims to test whether the involvement of men can improve care-seeking and promote healthy behaviours among postpartum women in Burkina Faso.

详细描述

There is a paucity of evidence on strategies to increase the uptake of postpartum contraception and attendance at facility-based postpartum care in developing countries, including in Sub-Saharan Africa. There is also a need to test new solutions to improve adherence to recommended infant feeding practices in these settings. Partner opposition is a major barrier to women's uptake of contraceptive methods in the postpartum period in Burkina Faso, and research has shown the need to sensitise and inform men about a broad range of topics related to reproductive health. However, the effect of involving male partners on women's and newborns' health and wellbeing in low-resource settings is not well known, and there is particularly little evidence for outcomes related to the postpartum period.

The aim of this study is to assess whether male partner involvement in maternity care has the potential to increase care-seeking and promote healthy behaviours among postpartum women in an urban West-African setting. A randomized controlled trial (RCT) of an intervention to promote the involvement in maternity care of the partners of pregnant women attending primary health care facilities will be conducted in the city of Bobo-Dioulasso. The intervention consists of three extra components in addition to standard maternity care: one extra couple counselling session during pregnancy (A), partner participation in a group education session for men (B), and partner participation in the pre-discharge consultation after birth (C). Women in the control group will receive standard maternity care only, in which men do not participate.

A qualitative component will be carried out alongside the RCT, in order to examine the factors that may have determined the success, or lack thereof, of the intervention by reflecting on the experience of participants (women, partners , and health workers), and to explore their attitudes, beliefs and concerns relative to partner involvement in maternity care, through focus group discussions and in-depth interviews.

The policy implications of the study findings will be assessed and, if appropriate, a strategy will be developed for their dissemination among policymakers and other stakeholders.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 16-18, married, or
  • Age 18+, in a co-habiting relationship
  • Pregnant 24-36 weeks
  • No obstetric risk factors requiring hospital delivery
  • Lives no more than one hour away on foot, not planning to move from the city
  • Gives informed consent

排除标准

  • Not meeting inclusion criteria
  • Declines to participate

研究组 & 干预措施

Intervention

Experimental
  • Receive standard maternity care
  • Woman and partner attend one extra couple counselling session during pregnancy (A)
  • Partner attends one group education session for men (B)
  • Partner participates in pre-discharge consultation (C)

干预措施: Partner involvement (Behavioral)

Control

No Intervention
  • Receive standard maternity care
  • No active encouragement of partner involvement, no extra sessions offered

结局指标

主要结局

Number of Participants Attending the Recommended Number of Postnatal Care Appointments

时间窗: Data collected at 3 months postpartum

This was defined as whether women had attended at least two outpatient postnatal care consultations/check-ups in the first six weeks after birth.

Number of Participants Practicing Exclusive Breastfeeding at 3 Months Postpartum

时间窗: Data collected at 3 months postpartum

This was defined according to the WHO criteria for exclusive breastfeeding: "the infant has received only breastmilk from his/her mother or a wet nurse, or expressed breastmilk, and no other liquids or solids with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines". Although the WHO recommends exclusive breastfeeding for the first 6 months postpartum, 3 months was chosen as the reference period because by that point only 20% of infants are still exclusively breastfed.

Number of Participants Using Effective Modern Contraception at 8 Months Postpartum

时间窗: Data collected at 8 months postpartum

Effective modern methods were defined as those having a rate of unintended pregnancy per 100 women of 10% or less per year, as commonly used. Based on local availability, these methods were: implants, IUDs, injectables, oral contraceptives, and permanent methods. Each woman was considered a "user" or "non-user" for each method.

次要结局

  • Number of Participants Using Long Acting or Permanent (LA/PM) Methods of Contraception at 8 Months Postpartum(Data collected at 8 months postpartum)
  • Number of Participants With High Relationship Adjustment at 8 Months Postpartum(Data collected at 8 months postpartum)
  • Number of Participants Using Any Contraceptive Method at 8 Months Postpartum(Data collected at 8 months postpartum)
  • Number of Participants Who Initiated Postpartum Contraception in a Timely Fashion(Data collected at 8 months postpartum)
  • Number of Participants With an Unmet Need for Contraception at 8 Months Postpartum(Data collected at 8 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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