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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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3 October 2023 |
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Main ID: |
ISRCTN82954580 |
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Date of registration:
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11/08/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Video edutainment at the doorstep: impact on maternal and infant outcomes in Toro local authority in Bauchi state, Nigeria
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Scientific title:
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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 |
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Date of first enrolment:
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01/03/2016 |
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Target sample size:
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18000 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN82954580 |
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Study type:
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Interventional |
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Study design:
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Cluster randomised controlled trial in stepped wedge design (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Anne
Cockcroft |
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Address:
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Department of Family Medicine
McGill University
5858 Côte-des-Neiges
Suite 300
H3Z 1Z1
Montreal
Canada |
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Email:
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Affiliation:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: Severe mental health problems making the person unable to give informed consent to participate and unable to respond to the administered questionnaire
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Maternal and infant morbidity and mortailty
Not Applicable
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Intervention(s)
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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.
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Primary Outcome(s)
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Measured using a household cluster survey after 3 years:
1. Maternal morbidity
2. Maternal mortality
3. Infant morbidity
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Secondary Outcome(s)
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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
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Secondary ID(s)
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108039-001 and 108039-002
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Source(s) of Monetary Support
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International Development Research Centre, Canadian Institutes of Health Research
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; 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
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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23/05/2020 |
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URL:
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