NCT06468319

Pregnancy Registry in Mali

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 9,500 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 15 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.

Detailed description

This pregnancy registry will gather background data on pregnancy rates and outcomes as well as infant health data to inform future implementation of clinical trials testing monoclonal antibodies (mAbs) to prevent malaria in pregnancy. In the first part of the study (Community Census Cohort), women of child-bearing age (WOCBA) in the community will be identified and followed for up to 3 years to detect pregnancy at all stages. Upon detection of pregnancy, these women may then transition to participation in the Health Facility Cohort. In the second part of the study (Health Facility Cohort), data will be prospectively collected from pregnant women presenting at the health facility for antenatal care (ANC) visits or referred in from the Community Census Cohort. The pregnant women will be followed through pregnancy outcome and until 12 months postpartum, and their infant(s) will be followed until 12 months of age. The study team will collect baseline information in a systematic manner on early pregnancy events, pregnancy and postpartum complications and outcomes, utilization of existing malaria prevention tools, malaria infections and clinical disease, birth outcomes, and follow-up of subsequent offspring.

Conditions

• Malaria
• Pregnancy Related

Timeline

• Start date: 2024-08-05
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2024-06-21
• Last updated: 2026-03-13

Locations

1 site across 1 country: Mali