Maternal HealthNCT06613867
Wakobo-ti-Kodro: Improving Identification of Pregnancy at Risk of Obstetric Complications at Community Level
An observational study of Maternal Health and Pregnancy Complications, run by Alliance for International Medical Action at 1 site in Central African Republic.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Pregnancy Complications
- What is being tested?
- Wakobotikodro
- How many people
- 1,857 participants
- Where
- 1 siteCentral African Republic
- Study dates
- 17 Jul 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country.
Central African Republic1 site
Bimbo health center,
Bimbo, Bangui Prefecture
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Maternal Health, Pregnancy Complications
- Being tested
- Wakobotikodro
- Keywords
- Traditional birth attendant, Digital health, Pregnancy at risk of complications identification, Collaboration with traditional birth attendant, Africa, Central African Republic
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WakobotikodroOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Comparison between baseline and endline data after 10 months of intervention
Secondary outcomes (7)
Antenatal consultancies (ANCs)
Evolution of monthly number of ANCs at health facilities
Measured: after 10 months of intervention
Delivery
Evolution of monthly number of delivery at health facilities
Measured: after 10 months of intervention
Post-partum consultancies
Evolution of monthly number of Post-partum consultancies at health facilities
Measured: after 10 months of intervention
Pregnant women at risk of obstetrical complication, screened by traditional birth attendants in the community
Evolution of monthly number of Pregnant women at risk, screened by traditional birth attendants in the community
Measured: after 10 months of intervention
Pregnant women at risk of obstetrical complication, monitored at health facilities
Evolution of monthly number of Pregnant women at risk of obstetrical complication, monitored at health facilities
Measured: after 10 months of intervention
Maternal mortality rate
Number of death of women while pregnant or within 42 days of termination of pregnancy
Measured: after 10 months of intervention
Neonatal mortality rate
Death of a live born infant, regardless of gestational age at birth, within the first 28 completed days of life
Measured: after 10 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start17 Jul 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,857 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Elrha, PACCI Program
- Responsible party
- Sponsor
- Investigators
- Richard Ngbale, Pr, Principal investigator, Faculté des sciences de la santé, BanguiRenaud Becquet, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613867
- Sponsor's protocol ID
- Wakobo ti Kodro
- Status last verified
- Feb 2025
- First submitted
- 19 Sep 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06613867
- Acronym / sponsor ID
- Wakobo ti Kodro
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,857 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Elrha, PACCI Program
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WakobotikodroWakobotikodro : 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. | Other | – |
Primary outcome
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
7 secondary outcomes
Antenatal consultancies (ANCs)
Time frame: after 10 months of intervention
Delivery
Time frame: after 10 months of intervention
Post-partum consultancies
Time frame: 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
Pregnant women at risk of obstetrical complication, monitored at health facilities
Time frame: after 10 months of intervention
Maternal mortality rate
Time frame: after 10 months of intervention
Neonatal mortality rate
Time frame: after 10 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- web page of Inserm websiteLink provided by the sponsor.
- page web of ELRHA websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Ngbale, Pr principal investigator
Faculté des sciences de la santé, Bangui
Renaud Becquet principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Health and Pregnancy Complications, run by Alliance for International Medical Action at 1 site in Central African Republic.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Central African Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deliveries in health facilities of women with complicated pregnancies (time frame: Comparison between baseline and endline data after 10 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.