Registry to assess pregnancy outcomes in Mali

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kayentao@icermali.org
• Phone: +223 7646 0173

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.