Postpartum PeriodNCT02309489
Involving Men in Maternity Care in Burkina Faso
A study testing Partner involvement in people with Postpartum Period, run by London School of Hygiene and Tropical Medicine at 1 site in Burkina Faso.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Period
- What is being tested?
- Partner involvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,144 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Jan 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not meeting inclusion criteria
- Declines to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postpartum Period
- Being tested
- Partner involvement
- Keywords
- Family Planning Services, Maternal Health Services, Breast Feeding, Contraception, Postnatal care, Postpartum contraception, Exclusive breastfeeding, Postpartum Period
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner involvementBehavioural
Partner is involved in maternity care
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Partner involvement |
| Control | No intervention | * Receive standard maternity care * No active encouragement of partner involvement, no extra sessions offered |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
This was defined as the number of women using IUDs, implants, female sterilization or male sterilization at 8 months postpartum.
Measured: Data collected at 8 months postpartum
Number of Participants Using Any Contraceptive Method 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.
Measured: Data collected at 8 months postpartum
Number of Participants Who Initiated Postpartum Contraception in a Timely Fashion
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).
Measured: Data collected at 8 months postpartum
Number of Participants With an Unmet Need for Contraception 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.
Measured: Data collected at 8 months postpartum
Number of Participants With High Relationship Adjustment 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.
Measured: Data collected at 8 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,144 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Strengthening Evidence for Programming on Unintended Pregnancy (STEP UP), Department for International Development, United Kingdom, Economic and Social Research Council, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Marina Daniele, MSc, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309489
- Sponsor's protocol ID
- QA649
- Status last verified
- Sep 2016
- First submitted
- 3 Dec 2014
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involving Men in Maternity Care in Burkina Faso
- ClinicalTrials.gov ID
- NCT02309489
- Acronym / sponsor ID
- QA649
- Conditions
- Postpartum Period
- Keywords
- Family Planning Services, Maternal Health Services, Breast Feeding, Contraception, Postnatal care, Postpartum contraception, Exclusive breastfeeding, Postpartum Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,144 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Strengthening Evidence for Programming on Unintended Pregnancy (STEP UP), Department for International Development, United Kingdom, Economic and Social Research Council, United Kingdom
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Partner involvement* 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) |
| Control | No intervention | –* Receive standard maternity care * No active encouragement of partner involvement, no extra sessions offered |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Not meeting inclusion criteria
- Declines to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partner involvementPartner is involved in maternity care | Behavioural | Intervention |
Primary outcome
Number of Participants Attending the Recommended Number of Postnatal Care Appointments
Time frame: 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.
Number of Participants Practicing Exclusive Breastfeeding at 3 Months Postpartum
Time frame: 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
Time frame: 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.
5 secondary outcomes
Number of Participants Using Long Acting or Permanent (LA/PM) Methods of Contraception at 8 Months Postpartum
Time frame: Data collected at 8 months postpartum
Number of Participants Using Any Contraceptive Method at 8 Months Postpartum
Time frame: Data collected at 8 months postpartum
Number of Participants Who Initiated Postpartum Contraception in a Timely Fashion
Time frame: Data collected at 8 months postpartum
Number of Participants With an Unmet Need for Contraception at 8 Months Postpartum
Time frame: Data collected at 8 months postpartum
Number of Participants With High Relationship Adjustment at 8 Months Postpartum
Time frame: Data collected at 8 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Daniele, MSc principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner involvement in people with Postpartum Period, run by London School of Hygiene and Tropical Medicine at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Attending the Recommended Number of Postnatal Care Appointments (time frame: Data collected at 3 months postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.