NCT02309489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

September 1, 2016

Enrollment Period

1.5 years

First QC Date

December 3, 2014

Results QC Date

December 14, 2018

Last Update Submit

April 12, 2019

Conditions

Keywords

Family Planning ServicesMaternal Health ServicesBreast FeedingContraceptionPostnatal carePostpartum contraceptionExclusive breastfeedingPostpartum Period

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Attending the Recommended Number of Postnatal Care Appointments

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

    Data collected at 3 months postpartum

  • Number of Participants Practicing Exclusive Breastfeeding 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.

    Data collected at 3 months postpartum

  • Number of Participants Using Effective Modern Contraception 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.

    Data collected at 8 months postpartum

Secondary Outcomes (5)

  • 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 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

  • Number of Participants With High Relationship Adjustment at 8 Months Postpartum

    Data collected at 8 months postpartum

Other Outcomes (2)

  • Number of Participants With Complete Satisfaction With Care

    Data collected at 3 months postpartum

  • Number of Participants in the Intervention Group With High Adherence to the Intervention

    Process data collected throughout intervention implementation

Study Arms (2)

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)

Behavioral: Partner involvement

Control

NO INTERVENTION

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

Interventions

Partner is involved in maternity care

Intervention

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Declines to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Sanitaire de Dafra

Bobo-Dioulasso, Burkina Faso

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Results Point of Contact

Title
Dr Marina Daniele
Organization
King's College London, UK

Study Officials

  • Marina Daniele, MSc

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 5, 2019

Results First Posted

July 5, 2019

Record last verified: 2016-09

Locations