Registry to assess pregnancy outcomes in Mali

Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali

This study is collecting information about pregnancy and baby health in Mali to help test new treatments for preventing malaria during pregnancy.

Quick facts

• Study type: Observational
• Enrollment: 9500 (estimated)
• Ages: 15 Years to 49 Years
• Sex: Female
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (nih)
• Locations: 1 site (Kalifabougou, Koulikoro)
• Trial ID: NCT06468319 on ClinicalTrials.gov

What this trial studies

This registry collects data on pregnancy rates and outcomes, as well as infant health, at a health facility in Kalifabougou, Mali. It involves two cohorts: the Community Census Cohort, which follows women of child-bearing age for up to three years to detect pregnancies, and the Health Facility Cohort, which gathers prospective data from pregnant women attending antenatal care. The aim is to inform future clinical trials testing monoclonal antibodies to prevent malaria in pregnancy by systematically collecting information on pregnancy events, complications, and outcomes.

Who should consider this trial

Good fit: Ideal candidates include females aged 15 to 49 who are either pregnant or of childbearing potential residing in the Kalifabougou area.

Not a fit: Patients who are temporarily residing in the study area or have conditions that may jeopardize their safety or rights may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could improve understanding of pregnancy outcomes and inform interventions to prevent malaria in pregnant women.

How similar studies have performed: Other studies have shown success in using registries to collect data on pregnancy outcomes, making this approach promising.

Eligibility criteria

Inclusion Criteria:

Community Census Cohort:

1. Females of childbearing potential or pregnant females.
2. Aged 15 to 49 years.
3. Able to provide verbal individual informed consent.

Health Facility Cohort:

1. Pregnant females 15 to 49 years and their subsequent offspring.
2. Resides in or in the health catchment area of Kalifabougou and willing to return to the health center for Antenatal Care (ANC) visits.
3. Able to provide written individual informed consent for herself and her future offspring(s).

Exclusion Criteria:

Community Census Cohort:

1. Temporary residence in the study area.
2. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.

Health Facility Cohort:

1. Temporary residence in the study area.
2. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.

Where this trial is running

Kalifabougou, Koulikoro

• Kalifabougou MRTC Clinic — Kalifabougou, Koulikoro, Mali (RECRUITING)

Study contacts

• Principal investigator: Kassoum Kayentao, MD, MPH, PhD — Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)
• Study coordinator: Kassoum Kayentao, MD, MPH, PhD

Conditions: Malaria, Pregnancy Related