Video edutainment at the doorstep: impact on maternal and infant outcomes in Toro local authority in Bauchi state, Nigeria
| ISRCTN | ISRCTN82954580 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82954580 |
| Secondary identifying numbers | 108039-001 and 108039-002 |
- Submission date
- 06/08/2017
- Registration date
- 11/08/2017
- Last edited
- 20/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Pregnant women attend health facilities to receive conventional antenatal care, but women at highest risk of morbidity (illness) and mortality (death) are least able to attend. Typically, they are socially isolated, overworked, poor, subject to gender violence and poorly educated. Nigeria has one of the highest rates of maternal mortality in the world, estimated as 576 deaths per 100,000 live births nationally and higher in Bauchi state. The Nigerian government has identified maternal mortality as a priority issue. Previous work in Bauchi state found four key links with negative outcomes of pregnancy: domestic violence, heavy work, lack of knowledge of danger signs, and lack of spousal communication about pregnancy. This study aims to answer the following questions:
1. Are universal home visits to pregnant women feasible and acceptable in northern Nigeria and what is their impact on pregnancy outcomes for mothers and babies?
2. How does adding video edutainment affect the feasibility and impact on pregnancy outcomes for mother and child?
3. In what way do home visits have an impact on pregnancy outcomes?
Who can participate?
Women of childbearing age (aged 14-49) living in six wards of Toro Local Government Authority (LGA) who are pregnant or who become pregnant during the study
What does the study involve?
The study tests the impact on mothers’ health of visiting all pregnant women every two months during their pregnancy and after delivery. In the visits, the female visitors ask them some questions about their health and discuss with them evidence about some problems that affect the outcome of pregnancy, and that can be tackled within the household: domestic violence, heavy work during pregnancy, lack of knowledge about danger signs of pregnancy, and lack of communication about pregnancy between women and their partners. Male workers visit the partners of the pregnant women to have the same discussions. The home visitors advise women with danger signs in their pregnancy to visit a health facility and provide a referral note for them. In half of the wards, the home visitors also show video clips to help the discussions about the problems that affect pregnancy outcomes. By the end of the study, all six wards have home visits in place. During the study, wards with home visits in place are compared with wards with home visits not yet in place. This includes comparing the number of deaths of mothers in visited and unvisited wards.
What are the possible benefits and risks of participating?
The intention of the home visits is to improve the health of pregnant women and their unborn children. The potential benefit of participating is a healthier pregnancy and a healthier baby. No risks are anticipated.
Where is the study run from?
Researchers from the department of Family Medicine at McGill University, Montreal, Canada, working in collaboration with staff of the Federation of Muslim Women Association of Nigeria (FOMWAN) in Bauchi, together with the Primary Health Care Development Agency (PHCDA) of the Ministry of Health, Bauchi State, Nigeria
When is the study starting and how long is it expected to run for?
August 2015 to May 2020
Who is funding the study?
The study is supported under the IMCHA programme (Innovating for Maternal and Child Health in Africa) with funding from the International Development Research Centre (IDRC) in Canada, Canadian Institutes for Health Research (CIHR) and Global Affairs Canada (GAC)
Who is the main contact?
Dr Anne Cockcroft
Contact information
Scientific
Department of Family Medicine
McGill University
5858 Côte-des-Neiges
Suite 300
Montreal
H3Z 1Z1
Canada
Study information
| Study design | Cluster randomised controlled trial in stepped wedge design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Video edutainment at the doorstep: impact on maternal and infant outcomes in Toro local authority in Bauchi state, Nigeria: a stepped wedge cluster randomised controlled trial |
| Study hypothesis | 1. Are universal home visits feasible, acceptable and appropriate in areas of northern Nigeria other than Giade? 2. How does adding evidence-based video edutainment affect the feasibility, impact on maternal/infant outcomes, and cost of universal home visits? 3. What is the mechanism of impact of home visits on maternal outcomes? |
| Ethics approval(s) | 1. Government of Bauchi State, Ministry of Health, 12/05/2015, ref: NREC/12/05/2015/12 2. McGill University, Faculty of Medicine IRB, 23/06/2015, ref: A06-B35-15A |
| Condition | Maternal and infant morbidity and mortailty |
| Intervention | Six wards in Toro Local Government Authority (LGA) in Bauchi State, Nigeria, are randomly allocated (allocation by statistician outside the local study team) to three waves of two wards. The study uses central, computer based randomisation by an epidemiologist not associated with the fieldwork. The randomisation is of whole districts, into intervention waves of 5 districts each, rather than randomisation of individuals. The duration of the intervention is three years. At this point, the primary and secondary outcomes will be measured in the five first wave (intervention) districts and in the five second wave districts, serving as the controls for the first wave districts. The “treatment” is a package of structural interventions implemented in the five districts allocated to the first wave. The study tests the impact on mothers’ health of visiting all pregnant women every two months during their pregnancy and after delivery. In the visits, the female visitors ask them some questions about their health and discuss with them evidence about some problems that affect the outcome of pregnancy, and that can be tackled within the household: domestic violence, heavy work during pregnancy, lack of knowledge about danger signs of pregnancy, and lack of communication about pregnancy between women and their partners. Male workers visit the partners of the pregnant women to have the same discussions. The home visitors advise women with danger signs in their pregnancy to visit a health facility and provide a referral note for them. In half of the wards, the home visitors also show video clips to help the discussions about the problems that affect pregnancy outcomes. |
| Intervention type | Behavioural |
| Primary outcome measure | Measured using a household cluster survey after 3 years: 1. Maternal morbidity 2. Maternal mortality 3. Infant morbidity |
| Secondary outcome measures | 1. Items in the CASCADA model of Conscious knowledge, Attitudes, Subjective norms, intention to Change, Agency, Discussion and Action, measured using a questionnaire administered in the household survey after 3 years 2. Feasibiity and acceptability of the home visits, assessed using household cluster survey after 3 years |
| Overall study start date | 24/08/2015 |
| Overall study end date | 23/05/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Approximately 18,000 pregnant women in the six wards covered during the trial |
| Total final enrolment | 26413 |
| Participant inclusion criteria | 1. All women of childbearing age living in the trial intervention wards 2. Women in the above category who become pregnant are registered and visited 2-monthly during pregnancy and after delivery 3. Spouses of the pregnant women are also visited |
| Participant exclusion criteria | Severe mental health problems making the person unable to give informed consent to participate and unable to respond to the administered questionnaire |
| Recruitment start date | 01/03/2016 |
| Recruitment end date | 31/12/2019 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
PMB 065, Bauchi
Nigeria
Sponsor information
University/education
Department of Family Medicine
5858 Côte-des-Neiges
Suite 300
Montreal
H3Z 1Z1
Canada
"ROR" |
https://ror.org/01pxwe438 |
|---|
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Centre de recherches pour le développement international, IDRC, CRDI
- Location
- Canada
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | 09/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study protocol is not yet published but the trialists intend to publish it. Planned publication of the results in a high-impact peer reviewed journal by the end of 2019. Updated 09/04/2019: The study protocol has now been published (see below). Updated 04/06/2021: Protocol and results published and further publications in review. |
| IPD sharing plan | The datasets generated during the study are not expected to be made available because the researchers did not seek agreement of the participants to make their data generally available for analysis by third parties. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/07/2018 | Yes | No | |
| Interim results article | interim results | 08/02/2019 | 09/04/2019 | Yes | No |
| Results article | 01/02/2021 | 04/06/2021 | Yes | No | |
| Results article | impact of home visits on male spouses | 05/02/2022 | 10/02/2022 | Yes | No |
| Results article | Impact of universal home visits on child health | 12/10/2021 | 20/09/2023 | Yes | No |
Editorial Notes
20/09/2023: Publication reference added.
10/02/2022: Publication reference added.
04/06/2021: The following changes have been made:
1. Publication reference added.
2. The intention to publish date has been changed from 31/12/2020 to 09/04/2019.
3. The publication and dissemination plan has been updated.
16/01/2020: The total final enrolment number has been added.
10/12/2019: The following changes have been made:
1. The recruitment end date has been changed from 30/11/2019 to 31/12/2019.
2. The intention to publish date has been changed from 31/12/2019 to 31/12/2020.
3. Corrected error in the publication stage.
10/04/2019: IPD sharing statement added.
09/04/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/03/2019 to 30/11/2019.
2. The overall trial end date was changed from 23/02/2020 to 23/05/2020.
3. Publication and dissemination plan updated.
4. Publication reference added.
05/07/2018: Publication reference added.
