Trial Outcomes & Findings for Involving Men in Maternity Care in Burkina Faso (NCT NCT02309489)
NCT ID: NCT02309489
Last Updated: 2019-07-05
Results Overview
This was defined as whether women had attended at least two outpatient postnatal care consultations/check-ups in the first six weeks after birth.
COMPLETED
NA
1144 participants
Data collected at 3 months postpartum
2019-07-05
Participant Flow
Participant milestones
| Measure |
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
|
Control
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Overall Study
STARTED
|
583
|
561
|
|
Overall Study
Follow-up at 3 Months Postpartum
|
560
|
541
|
|
Overall Study
COMPLETED
|
568
|
547
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Involving Men in Maternity Care in Burkina Faso
Baseline characteristics by cohort
| Measure |
Intervention
n=583 Participants
* 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
|
Control
n=561 Participants
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
Total
n=1144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
15-19
|
73 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Age, Customized
20-24
|
179 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
|
Age, Customized
25-29
|
163 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
321 Participants
n=5 Participants
|
|
Age, Customized
30-34
|
109 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Age, Customized
35-39
|
46 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Age, Customized
40-45
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
583 Participants
n=5 Participants
|
561 Participants
n=7 Participants
|
1144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Bobo, Bwa
|
109 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Dagara, Lobi, Birifor, Djan, & similar
|
61 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Dioula, Dafing, Samo, & similar
|
93 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Gourounsi, Ko, Nounouma
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mossi, Gourmanche, Bissa, & similar
|
260 Participants
n=5 Participants
|
263 Participants
n=7 Participants
|
523 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Peulh
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Health centre of recruitment
Bolomakote
|
89 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Health centre of recruitment
Guimbi
|
101 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Health centre of recruitment
Ouezzinville
|
163 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
328 Participants
n=5 Participants
|
|
Health centre of recruitment
Sarfalao
|
119 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Health centre of recruitment
Secteur 24
|
111 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Religion
Muslim
|
420 Participants
n=5 Participants
|
407 Participants
n=7 Participants
|
827 Participants
n=5 Participants
|
|
Religion
Christian
|
158 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Religion
Traditional/animist
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Religion
No religion
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
No education
|
311 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
589 Participants
n=5 Participants
|
|
Education
At most primary completed
|
145 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
313 Participants
n=5 Participants
|
|
Education
Above primary
|
126 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Parity
No children
|
127 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Parity
1 child
|
159 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Parity
2 children
|
119 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Parity
3 children or more
|
178 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
370 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Data collected at 3 months postpartumThis was defined as whether women had attended at least two outpatient postnatal care consultations/check-ups in the first six weeks after birth.
Outcome measures
| Measure |
Intervention
n=560 Participants
* 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
|
Control
n=541 Participants
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Number of Participants Attending the Recommended Number of Postnatal Care Appointments
|
342 Participants
|
265 Participants
|
PRIMARY outcome
Timeframe: Data collected at 3 months postpartumThis 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.
Outcome measures
| Measure |
Intervention
n=535 Participants
* 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
|
Control
n=511 Participants
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Number of Participants Practicing Exclusive Breastfeeding at 3 Months Postpartum
|
232 Participants
|
161 Participants
|
PRIMARY outcome
Timeframe: Data collected at 8 months postpartumEffective 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.
Outcome measures
| Measure |
Intervention
n=554 Participants
* 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
|
Control
n=533 Participants
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Number of Participants Using Effective Modern Contraception at 8 Months Postpartum
|
330 Participants
|
283 Participants
|
SECONDARY outcome
Timeframe: Data collected at 8 months postpartumThis was defined as the number of women using IUDs, implants, female sterilization or male sterilization at 8 months postpartum.
Outcome measures
| Measure |
Intervention
n=554 Participants
* 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
|
Control
n=533 Participants
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Number of Participants Using Long Acting or Permanent (LA/PM) Methods of Contraception at 8 Months Postpartum
|
170 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: Data collected at 8 months postpartumThis 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.
Outcome measures
| Measure |
Intervention
n=554 Participants
* 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
|
Control
n=533 Participants
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Number of Participants Using Any Contraceptive Method at 8 Months Postpartum
|
391 Participants
|
343 Participants
|
SECONDARY outcome
Timeframe: Data collected at 8 months postpartumWhether 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).
Outcome measures
| Measure |
Intervention
n=329 Participants
* 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
|
Control
n=281 Participants
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Number of Participants Who Initiated Postpartum Contraception in a Timely Fashion
|
249 Participants
|
188 Participants
|
SECONDARY outcome
Timeframe: Data collected at 8 months postpartumUnmet 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.
Outcome measures
| Measure |
Intervention
n=560 Participants
* 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
|
Control
n=539 Participants
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Number of Participants With an Unmet Need for Contraception at 8 Months Postpartum
|
79 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: Data collected at 8 months postpartumRelationship 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.
Outcome measures
| Measure |
Intervention
n=568 Participants
* 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
|
Control
n=457 Participants
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Number of Participants With High Relationship Adjustment at 8 Months Postpartum
|
323 Participants
|
263 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Data collected at 3 months postpartumA 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.
Outcome measures
| Measure |
Intervention
n=560 Participants
* 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
|
Control
n=541 Participants
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Number of Participants With Complete Satisfaction With Care
|
413 Participants
|
395 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Process data collected throughout intervention implementationHigh adherence to the intervention was defined as attendance (by the couple or the partner) at at least two out of three intervention components.
Outcome measures
| Measure |
Intervention
n=583 Participants
* 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
|
Control
* Receive standard maternity care
* No active encouragement of partner involvement, no extra sessions offered
|
|---|---|---|
|
Number of Participants in the Intervention Group With High Adherence to the Intervention
|
432 Participants
|
—
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place