Pregnancy Registry in Mali

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Enrolling

Conditions: Pregnancy Related; Malaria

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06468319

2024/84/CE/USTTB

Details and patient eligibility

About

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

Full 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.

Enrollment: 9,500 estimated patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

9,500 participants in 3 patient groups

Community Census Cohort

Description:

Women of child-bearing aged (WOCBA) identified within the community.

Health Facility Cohort

Description:

Pregnant women presenting at the health facility for antenatal care or referred in from the Community Consensus Cohort.

Offspring from Health Facility Cohort

Description:

Children born to women in the health facility cohort.