Pregnancy Registry in Mali

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

9500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-05

Study Completion Date

2030-06-30

Brief Summary

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

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Detailed Description

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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

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Malaria Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Community Census Cohort

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

No interventions assigned to this group

Health Facility Cohort

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

No interventions assigned to this group

Offspring from Health Facility Cohort

Children born to women in the health facility cohort.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes