Clinical trial NCT06613867: Wakobo-ti-Kodro: Improving Identification of Pregnancy at Risk of Obstetric Complications at Community Level
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Health
Pregnancy Complications
Keywords: Traditional birth attendant
Digital health
Pregnancy at risk of complications identification
Collaboration with traditional birth attendant
Africa
Central African Republic
Lead sponsor: Alliance for International Medical Action
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Elrha
name: PACCI Program
First posted: 2024-09-26
Enrollment: 1857
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Deliveries in health facilities of women with complicated pregnancies
timeFrame: Comparison between baseline and endline data after 10 months of intervention
Secondary outcomes:
measure: Antenatal consultancies (ANCs)
timeFrame: after 10 months of intervention
measure: Delivery
timeFrame: after 10 months of intervention
measure: Post-partum consultancies
timeFrame: after 10 months of intervention
measure: Pregnant women at risk of obstetrical complication, screened by traditional birth attendants in the community
timeFrame: after 10 months of intervention
measure: Pregnant women at risk of obstetrical complication, monitored at health facilities
timeFrame: after 10 months of intervention
measure: Maternal mortality rate
timeFrame: after 10 months of intervention
measure: Neonatal mortality rate
timeFrame: after 10 months of intervention
Other outcomes:
Locations:
city: Bimbo
country: Central African Republic
facility: Bimbo health center,
state: Bangui
Study officials:
affiliation: Faculté des sciences de la santé, Bangui
name: Richard Ngbale, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Renaud Becquet
role: PRINCIPAL_INVESTIGATOR
References: