NCT06613867

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,857

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

September 19, 2024

Last Update Submit

February 11, 2025

Conditions

Keywords

Traditional birth attendantDigital healthPregnancy at risk of complications identificationCollaboration with traditional birth attendantAfricaCentral African Republic

Outcome Measures

Primary Outcomes (1)

  • Deliveries in health facilities of women with complicated pregnancies

    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 Outcomes (7)

  • Antenatal consultancies (ANCs)

    after 10 months of intervention

  • Delivery

    after 10 months of intervention

  • Post-partum consultancies

    after 10 months of intervention

  • Pregnant women at risk of obstetrical complication, screened by traditional birth attendants in the community

    after 10 months of intervention

  • Pregnant women at risk of obstetrical complication, monitored at health facilities

    after 10 months of intervention

  • +2 more secondary outcomes

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Aggregated data of pregnant women, regardless of the age of their pregnancy, and
  • attending the health facilities included in the study
  • Being a pregnant woman residing in the study area and
  • attending the health facilities included in the study and
  • with a given individual consent.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bimbo health center,

Bimbo, Bangui Prefecture, Central African Republic

Location

Related Links

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 26, 2024

Study Start

July 17, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations