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Completed

NCT Number: NCT06613867

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Bimbo health center,

Bimbo, Bangui Prefecture, Central African Republic

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wakobotikodro

Other

Wakobotikodro : an intervention combining (i) training matrons to identify and monitor high-risk pregnancies, (ii) integrating them into the healthcare system and (iii) using a digital decision-support application installed on a smartphone and adapted to their profile, could improve the identification and monitoring of high-risk pregnancies.

Primary outcomes

  1. 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

Secondary outcomes

  1. Antenatal consultancies (ANCs)

    Time frame: after 10 months of intervention

    Evolution of monthly number of ANCs at health facilities

  2. Delivery

    Time frame: after 10 months of intervention

    Evolution of monthly number of delivery at health facilities

  3. Post-partum consultancies

    Time frame: after 10 months of intervention

    Evolution of monthly number of Post-partum consultancies at health facilities

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Alliance for International Medical Action

Other

Collaborators

  • Elrha
  • Institut National de la Santé Et de la Recherche Médicale, France
  • PACCI Program

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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