Data for “Involving male partners in maternity care in Burkina Faso: a randomized controlled trial” - User Guide

Alternative Title

Base de données de l’étude “La participation des conjoints aux activities de soins de maternité au Burkina Faso : un essai randomisé

Data Description

Dataset and supplementary material collected as part of a public health intervention study. The study sought to determine whether an intervention to involve male partners in maternity care of pregnant women influenced care-seeking, healthy breastfeeding and contraceptive practices after childbirth.

The dataset includes baseline socio-demographic data on study participants, information about treatment arm assignment and adherence to the intervention, and health and behaviour outcomes in the postpartum period. It brings together data from four collection points:

1. the baseline interview,
2. the 3-month postpartum follow-up interview,
3. the 8-month postpartum follow-up interview,
4. process data on attendance at the three intervention sessions.

Also included are the informed consent form, the information sheet, and the three questionnaires for the baseline interview, 3-month and 8-month postpartum follow-up interviews.

Data Collection Methods

In a non-blinded, multicentre, parallel-group, superiority trial, 1144 pregnant women were assigned by simple randomization to two study arms: 583 entered the intervention arm and 561 entered the control arm. All women were cohabiting with a male partner and had a low-risk pregnancy. Recruitment took place at 20 to 36 weeks’ gestation at five primary health centres in Bobo-Dioulasso. The intervention comprised three educational sessions: (i) an interactive group session during pregnancy with male partners only, to discuss their role; (ii) a counselling session during pregnancy for individual couples; and (iii) a postnatal couple counselling session before discharge. The control group received routine care only. Data were collected through interviewer-administered questionnaires at three timepoints: enrolment (baseline), at 3 months postpartum (follow-up), and at 8 months postpartum (follow-up). Process data on adherence to the intervention were also collected from registers of session attendees, compiled and maintained by staff at the primary health centres.

Data Analysis and Preparation

Data were collected on paper questionnaires, double-entered into EpiData and inconsistencies/errors solved by going back to the paper forms, under supervision of a data manager. Data were imported into STATA-14 for cleaning and analysis. Datasets for each interview were merged into a single dataset, together with the process data.

Geographic regions

City of Bobo-Dioulasso, Burkina Faso.

Key dates

The data were collected between February 2015 and June 2016. The final version of the data was produced on 23^rd January 2019.

Quality Controls

The following quality controls were applied during the study:

• Data collection tools were field tested in order to maximise quality. Checks were built into the electronic data entry form to enable recognition of common mistakes.
• Data collectors received extensive training prior to going into the field and worked as buddies for the first week of administration of each questionnaire.
• A supervisor conducted regular spot checks on interviewer performance by visiting them in the field and observing their work. She double-checked each completed paper form for errors and missing data.
• Repeat interviews with women were conducted in a few cases for quality monitoring.
• Other errors and inconsistencies were found by the P.I. at the time of data cleaning, and if necessary the paper forms were consulted and/or the interviewer was asked to go back to the field.

Species:

Human population

Privacy:

Personal and sensitive data collected were stored in a secure location during the study – paper forms were held in locked premises and have since been destroyed; electronic versions were kept on encrypted drives.

Basic de-identification was performed when preparing data for submission to the digital repository – birth dates, delivery dates, and interview dates were changed to month/year.

Further de-identification will be performed when it is requested by a researcher. Editing will be performed upon a case-by-case basis, depending upon the variables requested.

Ethics

Ethics approval was obtained from the LSHTM Observational/Interventions Research Ethics Committee on 19th Dec 2014 (LSHTM Ethics Ref 8787).

Ethics approval was also provided by the Ethics Committee for Health Research of the Ministry of Health and the Ministry for Scientific Research and Innovation in Burkina Faso, and by the Population Council Institutional Review Board.

Keywords

Public health intervention, Male partner involvement, Postpartum period, Pregnancy, Exclusive breastfeeding, Postnatal care, Postpartum family planning, Randomized controlled trial

Language of written material

French-language questionnaires were used for data collection. Dataset variable names and labels are written in English.

Project title

Involving male partners in maternity care in Burkina Faso: a randomized controlled trial

Funder/Sponsor

The study was funded by:

• The Strengthening Evidence for Programming on Unintended Pregnancy (STEP UP) Research Program Consortium (grant code EPIDHC20). STEP UP is funded by UKaid from the Department for International Development.
• Contribution from the Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine.
• Marina A.S. Daniele’s studies at the London School of Hygiene & Tropical Medicine were funded by the Economic and Social Research Council.

Grant Number

DFID grant code EPIDHC20

Additional Information

The trial was registered on ClinicalTrials.gov with the Identifier NCT02309489.

The results of the trial are published in: Daniele MAS, Ganaba R., Sarrassat S., Cousens S., Rossier C., Ouedraogo D., Drabo S., Filippi V. 2018 Involving male partners in maternity care in Burkina Faso: A randomized controlled trial. Bulletin of the World Health Organization 96(7):450-461. This is available online at: https://www.who.int/bulletin/volumes/96/7/17-206466.pdf

The study is fully described in Marina Daniele’s PhD thesis: Daniele, M (2017) Involving Men in Maternity Care in Burkina Faso: An Intervention Study. PhD thesis, London School of Hygiene & Tropical Medicine. DOI: https://doi.org/10.17037/PUBS.04645532.

Please contact Dr Marina Daniele at marina.daniele@kcl.ac.uk or Prof Veronique Filippi at veronique.filippi@lshtm.ac.uk for further information.

Data Creators

File Description