- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06613867
Wakobo-ti-Kodro: Improving Identification of Pregnancy At Risk of Obstetric Complications At Community Level
Wakobo Ti Kodro: a Quasi-experimental Study to Improve the Identification and Follow-up of Pregnant Women At Risk of Obstetric Complications in the Community by Traditional Birth Attendants in the Central African Republic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a quasi-experimental study with a before (baseline measurement) and after (final measurement) approach combined with 2) an exploratory prospective observational cohort study and 3) a sub-study using a mixed methodology.
The main objective is to assess a composite intervention implementation combining the integration of Traditional Birth Attendants (TBAs) into the health system through a strengthened collaboration with health facilities with the support of a numeric application aiming at registering pregnant women & identifying those at high risk of obstetric complications.
The secondary objectives are to:
- Describe the characteristics of antenatal care, pregnancy outcomes, postnatal care, maternal and neonatal mortality, and changes in the use of health facilities by pregnant women.
- To assess the acceptability and feasibility of this intervention with matrons, community health workers, community representatives, women who have already given birth in the study area and health staff involved in the study, in order to understand the potential levers and barriers to the implementation of the intervention.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bangui
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Bimbo, Bangui, Central African Republic
- Bimbo health center,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The main study population is pregnant women attending the health facilities included in the study.
Secondary population are beneficiaries of the intervention tested: traditional birth attendants, health workers, community health workers, community representatives, women who have already given birth or pregnant women or their husbands living in the study area.
Description
Inclusion Criteria for the main study (quasi-experimental study with a before-after approach)
- Aggregated data of pregnant women, regardless of the age of their pregnancy, and
- attending the health facilities included in the study
Inclusion Criteria for participating in the observational cohort:
- Being a pregnant woman residing in the study area and
- attending the health facilities included in the study and
- with a given individual consent.
Inclusion Criteria for participating in the sub-study on intervention's acceptability and feasibility:
- traditional birth attendants (TBAs) or
- health workers working in health facilities or
- community health workers or
- community representatives or
- women who have already given birth or pregnant women or their husbands AND
- All with a given individual consent AND
- All being part of the study area.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Deliveries in health facilities of women with complicated pregnancies
Time Frame: Comparison between baseline and endline data after 10 months of intervention
|
Proportion of deliveries by pregnant women at risk of obstetric complications among all women who give birth in the health facilities included in the study, after 10 months of intervention
|
Comparison between baseline and endline data after 10 months of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antenatal consultancies (ANCs)
Time Frame: after 10 months of intervention
|
Evolution of monthly number of ANCs at health facilities
|
after 10 months of intervention
|
|
Delivery
Time Frame: after 10 months of intervention
|
Evolution of monthly number of delivery at health facilities
|
after 10 months of intervention
|
|
Post-partum consultancies
Time Frame: after 10 months of intervention
|
Evolution of monthly number of Post-partum consultancies at health facilities
|
after 10 months of intervention
|
|
Pregnant women at risk of obstetrical complication, screened by traditional birth attendants in the community
Time Frame: after 10 months of intervention
|
Evolution of monthly number of Pregnant women at risk, screened by traditional birth attendants in the community
|
after 10 months of intervention
|
|
Pregnant women at risk of obstetrical complication, monitored at health facilities
Time Frame: after 10 months of intervention
|
Evolution of monthly number of Pregnant women at risk of obstetrical complication, monitored at health facilities
|
after 10 months of intervention
|
|
Maternal mortality rate
Time Frame: after 10 months of intervention
|
Number of death of women while pregnant or within 42 days of termination of pregnancy
|
after 10 months of intervention
|
|
Neonatal mortality rate
Time Frame: after 10 months of intervention
|
Death of a live born infant, regardless of gestational age at birth, within the first 28 completed days of life
|
after 10 months of intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard Ngbale, Pr, Faculté des sciences de la santé, Bangui
- Principal Investigator: Renaud Becquet, Institut National de la Santé Et de la Recherche Médicale, France
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wakobo ti Kodro
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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