Wakobo-ti-Kodro: Improving Identification of Pregnancy At Risk of Obstetric Complications At Community Level

February 11, 2025 updated by: Alliance for International Medical Action

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

This project aims to improve maternal health indicators in a national context where the maternal mortality rate is one of the highest in the world. Our hypothesis is that an intervention combining (i) the training of traditional birth attendant in the identification and monitoring of high-risk pregnancies, (ii) their integration into the health system and (iii) the use of a digital decision-support application installed on a smartphone and adapted to their profile, could strengthen the identification and monitoring of high-risk pregnancies, increase attendance at facilities and thus the rate of assisted deliveries in health facilities, in Bimbo district around the capital Bangui in the Central African republic.

Study Overview

Status

Completed

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:

  1. 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.
  2. 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

Observational

Enrollment (Actual)

1857

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Pregnancy Complications

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