Viewing Study NCT06613867


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Study NCT ID: NCT06613867
Status: COMPLETED
Last Update Posted: 2025-02-12
First Post: 2024-09-19
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Wakobo-ti-Kodro: Improving Identification of Pregnancy at Risk of Obstetric Complications at Community Level
Sponsor: Alliance for International Medical Action
Organization:

Study Overview

Official 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
Status: COMPLETED
Status Verified Date: 2025-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: