Overview

This trial is active, not recruiting.

Condition postpartum period
Treatment partner involvement
Sponsor London School of Hygiene and Tropical Medicine
Collaborator Strengthening Evidence for Programming on Unintended Pregnancy (STEP UP)
Start date January 2015
End date January 2017
Trial size 1115 participants
Trial identifier NCT02309489, QA649

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(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)
partner involvement
Partner is involved in maternity care
(No Intervention)
Receive standard maternity care No active encouragement of partner involvement, no extra sessions offered

Primary Outcomes

Measure
Use of effective modern contraception at 8 months postpartum
time frame: 8 months postpartum
Postpartum care attendance
time frame: 8 months postpartum
Exclusive breastfeeding at 3 months postpartum
time frame: 8 months postpartum

Secondary Outcomes

Measure
Use of long acting or permanent (LA/PM) methods of contraception at 8 months postpartum
time frame: 8 months postpartum
Contraceptive use over the 8-month postpartum period
time frame: 8 months postpartum
Timeliness of initiation of postpartum contraception
time frame: 8 months postpartum
Unmet need for contraception at 8 months postpartum
time frame: 8 months postpartum
Relationship adjustment at 8 months postpartum
time frame: 8 months postpartum

Eligibility Criteria

Female participants at least 16 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - Not meeting inclusion criteria - Declines to participate

Additional Information

Official title Involving Men in Maternity Care in Burkina Faso
Principal investigator Marina Daniele, MSc
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by London School of Hygiene and Tropical Medicine.