Involving Men in Maternity Care in Burkina Faso

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02309489

Enrollment

1144

Registered

2014-12-05

Start date

2015-01-31

Completion date

2016-07-31

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Period

Keywords

Family Planning Services, Maternal Health Services, Breast Feeding, Contraception, Postnatal care, Postpartum contraception, Exclusive breastfeeding, Postpartum Period

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.

Interventions

BEHAVIORALPartner involvement

Partner is involved in maternity care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Practicing Exclusive Breastfeeding at 3 Months Postpartum	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	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.
Number of Participants Attending the Recommended Number of Postnatal Care Appointments	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.

Secondary

Measure	Time frame	Description
Number of Participants Who Initiated Postpartum Contraception in a Timely Fashion	Data collected at 8 months postpartum	Whether or not users of modern contraception at 8 months postpartum had initiated their method in a timely fashion was assessed. This was a binary outcome with users of effective methods as the denominator. Users were considered to have initiated contraception either in a timely fashion, or not in a timely fashion. Timeliness in this context refers to whether women had been exposed to a significant risk of becoming pregnant prior to initiating their contraceptive method. Specifically, whether or not women using contraception had initiated it in a timely fashion (timeliness) was defined based on the interaction between four criteria: when they initiated the method (either in the first 6 months postpartum or later); whether they had reported to be exclusively breastfeeding at 3 months postpartum (yes or no); whether at that point in time they had resumed intercourse (yes or no); and whether at that point their menses had returned (yes or no).
Number of Participants With High Relationship Adjustment at 8 Months Postpartum	Data collected at 8 months postpartum	Relationship adjustment, as defined in this study, was a score calculated based on questions related to: woman's self-reported satisfaction with the relationship; her level of communication and agreement with her male partner on issues related to reproductive health; and who in the household made decisions related to reproductive health and any relevant expenditures. The questions used were derived from similar survey measures (Spanier's Dyadic Adjustment Scale and the Locke-Wallace Marital Adjustment Test (LWMAT)). The median score was chosen as a cut-off point, above which women were considered to have high relationship adjustment, and below which they were considered to have low relationship adjustment.
Number of Participants With an Unmet Need for Contraception at 8 Months Postpartum	Data collected at 8 months postpartum	Unmet need for contraception is a concept used to describe the situation in which women are at risk of conceiving, yet do not wish to become pregnant. Several definitions of unmet need for contraception have been proposed. The Revised definition of unmet need published by the DHS Program in 2012 was chosen. This definition classifies women as either having an unmet need, or not, based on the interaction of several criteria: whether or not they wanted the index pregnancy; whether or not their periods have returned after giving birth; whether or not they want to become pregnant again, and if so how soon.
Number of Participants Using Long Acting or Permanent (LA/PM) Methods of Contraception at 8 Months Postpartum	Data collected at 8 months postpartum	This was defined as the number of women using IUDs, implants, female sterilization or male sterilization at 8 months postpartum.
Number of Participants Using Any Contraceptive Method at 8 Months Postpartum	Data collected at 8 months postpartum	This was defined as the use of all contraceptive methods, according to self-report at 8 months postpartum. The aim of this measure was to quantify the use of natural methods, such as withdrawal, which, based on the literature, may be higher than reported in DHS surveys.

Other

Measure	Time frame	Description
Number of Participants With Complete Satisfaction With Care	Data collected at 3 months postpartum	A tailored satisfaction score was developed to assess participant's satisfaction with routine maternity care received. Questions were adapted from the K4 Health's Respectful Maternity Care toolkit, and from the UK's Care Quality Commission (CQC)'s 2013 Maternity Services Survey. If participants reported having experienced the maximum score for each dimension of satisfaction, they were classed as having complete satisfaction with care.
Number of Participants in the Intervention Group With High Adherence to the Intervention	Process data collected throughout intervention implementation	High adherence to the intervention was defined as attendance (by the couple or the partner) at at least two out of three intervention components.

Countries

Burkina Faso

Participant flow

Participants by arm

Arm	Count
Intervention * 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	583
Control * Receive standard maternity care * No active encouragement of partner involvement, no extra sessions offered	561
Total	1,144

Baseline characteristics

Characteristic	Intervention	Control	Total
Age, Customized 15-19	73 Participants	76 Participants	149 Participants
Age, Customized 20-24	179 Participants	164 Participants	343 Participants
Age, Customized 25-29	163 Participants	158 Participants	321 Participants
Age, Customized 30-34	109 Participants	99 Participants	208 Participants
Age, Customized 35-39	46 Participants	56 Participants	102 Participants
Age, Customized 40-45	13 Participants	9 Participants	22 Participants
Education Above primary	126 Participants	115 Participants	241 Participants
Education At most primary completed	145 Participants	168 Participants	313 Participants
Education No education	311 Participants	278 Participants	589 Participants
Health centre of recruitment Bolomakote	89 Participants	86 Participants	175 Participants
Health centre of recruitment Guimbi	101 Participants	109 Participants	210 Participants
Health centre of recruitment Ouezzinville	163 Participants	165 Participants	328 Participants
Health centre of recruitment Sarfalao	119 Participants	92 Participants	211 Participants
Health centre of recruitment Secteur 24	111 Participants	109 Participants	220 Participants
Parity 1 child	159 Participants	132 Participants	291 Participants
Parity 2 children	119 Participants	93 Participants	212 Participants
Parity 3 children or more	178 Participants	192 Participants	370 Participants
Parity No children	127 Participants	144 Participants	271 Participants
Race/Ethnicity, Customized Bobo, Bwa	109 Participants	110 Participants	219 Participants
Race/Ethnicity, Customized Dagara, Lobi, Birifor, Djan, & similar	61 Participants	41 Participants	102 Participants
Race/Ethnicity, Customized Dioula, Dafing, Samo, & similar	93 Participants	85 Participants	178 Participants
Race/Ethnicity, Customized Gourounsi, Ko, Nounouma	24 Participants	24 Participants	48 Participants
Race/Ethnicity, Customized Mossi, Gourmanche, Bissa, & similar	260 Participants	263 Participants	523 Participants
Race/Ethnicity, Customized Other	21 Participants	15 Participants	36 Participants
Race/Ethnicity, Customized Peulh	16 Participants	19 Participants	35 Participants
Religion Christian	158 Participants	144 Participants	302 Participants
Religion Muslim	420 Participants	407 Participants	827 Participants
Religion No religion	1 Participants	0 Participants	1 Participants
Religion Traditional/animist	1 Participants	5 Participants	6 Participants
Sex: Female, Male Female	583 Participants	561 Participants	1144 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 583	1 / 561
other Total, other adverse events	0 / 583	0 / 561
serious Total, serious adverse events	0 / 583	0 / 561

Outcome results

Primary

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.

Time frame: Data collected at 3 months postpartum

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Intervention	Number of Participants Attending the Recommended Number of Postnatal Care Appointments	342 Participants
Control	Number of Participants Attending the Recommended Number of Postnatal Care Appointments	265 Participants

Primary

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.

Time frame: Data collected at 3 months postpartum

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Intervention	Number of Participants Practicing Exclusive Breastfeeding at 3 Months Postpartum	232 Participants
Control	Number of Participants Practicing Exclusive Breastfeeding at 3 Months Postpartum	161 Participants

Primary

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.