Condition category
Not Applicable
Date applied
06/08/2017
Date assigned
11/08/2017
Last edited
10/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 February 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anne Cockcroft

ORCID ID

Contact details

Department of Family Medicine
McGill University
5858 Côte-des-Neiges
Suite 300
Montreal
H3Z 1Z1
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

108039-001 and 108039-002

Study information

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

Acronym

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

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

Study design

Cluster randomised controlled trial in stepped wedge design

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

24/08/2015

Overall trial end date

23/02/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. All women of child-bearing 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 type

Other

Age group

Adult

Gender

Both

Target number of participants

Approximately 18,000 pregnant women in the six wards covered during the trial

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

01/03/2019

Locations

Countries of recruitment

Nigeria

Trial participating centre

Bauchi State Ministry of Health, Primary Health Care Development Agency
Bauchi
PMB 065, Bauchi
Nigeria

Sponsor information

Organisation

McGill University

Sponsor details

Department of Family Medicine
5858 Côte-des-Neiges
Suite 300
Montreal
H3Z 1Z1
Canada

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

International Development Research Centre

Alternative name(s)

Centre de recherches pour le développement international, Centre de recherches pour le développement international, IDRC

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Canada

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

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.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes