Clinical trial NCT02309489: Involving Men in Maternity Care in Burkina Faso
Official title: Involving Men in Maternity Care in Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Period
Keywords: Family Planning Services
Maternal Health Services
Breast Feeding
Contraception
Postnatal care
Postpartum contraception
Exclusive breastfeeding
Postpartum Period
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Strengthening Evidence for Programming on Unintended Pregnancy (STEP UP)
name: Department for International Development, United Kingdom
name: Economic and Social Research Council, United Kingdom
First posted: 2014-12-05
Enrollment: 1144
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Attending the Recommended Number of Postnatal Care Appointments
timeFrame: Data collected at 3 months postpartum
measure: Number of Participants Practicing Exclusive Breastfeeding at 3 Months Postpartum
timeFrame: Data collected at 3 months postpartum
measure: Number of Participants Using Effective Modern Contraception at 8 Months Postpartum
timeFrame: Data collected at 8 months postpartum
Secondary outcomes:
measure: Number of Participants Using Long Acting or Permanent (LA/PM) Methods of Contraception at 8 Months Postpartum
timeFrame: Data collected at 8 months postpartum
measure: Number of Participants Using Any Contraceptive Method at 8 Months Postpartum
timeFrame: Data collected at 8 months postpartum
measure: Number of Participants Who Initiated Postpartum Contraception in a Timely Fashion
timeFrame: Data collected at 8 months postpartum
measure: Number of Participants With an Unmet Need for Contraception at 8 Months Postpartum
timeFrame: Data collected at 8 months postpartum
measure: Number of Participants With High Relationship Adjustment at 8 Months Postpartum
timeFrame: Data collected at 8 months postpartum
Other outcomes:
measure: Number of Participants With Complete Satisfaction With Care
timeFrame: Data collected at 3 months postpartum
measure: Number of Participants in the Intervention Group With High Adherence to the Intervention
timeFrame: Process data collected throughout intervention implementation
Locations:
city: Bobo Dioulasso
country: Burkina Faso
facility: District Sanitaire de Dafra
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Marina Daniele, MSc
role: PRINCIPAL_INVESTIGATOR
References: