Clinical trial NCT06468319: Pregnancy Registry in Mali
Official title: Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malaria
Pregnancy Related
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: National Institutes of Health (NIH)
name: University of Washington
First posted: 2024-06-21
Enrollment: 9500
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Malian females of childbearing age (15-49 years) Community Census Cohort: 4000 unique women Health Facility Cohort: 2500 unique women (inclusive of women who transition for enrollment from the Community Census Cohort)

Offspring from Health Facility Cohort: 3000 children

Brief 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.

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.

Primary outcomes:
measure: Number of pregnancies
timeFrame: Through study completion, an average of 1 year
measure: Number of malaria cases
timeFrame: Through study completion, an average of 1 year
measure: Incidence of placental malaria
timeFrame: Through study completion, an average of 1 year
measure: Use of other malaria prevention tools
timeFrame: Through study completion, an average of 1 year
measure: Number of Participants with anemia during pregnancy and post-partum
timeFrame: Through study completion, an average of 1 year
measure: Dating of pregnancies
timeFrame: Through study completion, an average of 1 year
measure: Number of Maternal Deaths
timeFrame: Through study completion, an average of 1 year
measure: Number of fetal Losses and Stillbirths
timeFrame: Through study completion, an average of 1 year
measure: Number of multiple gestations
timeFrame: Through study completion, an average of 1 year
measure: Incidence of preterm delivery
timeFrame: Through study completion, an average of 1 year
measure: Occurrence of chronic medical conditions
timeFrame: Through study completion, an average of 1 year
measure: Occurrence of pregnancy and post-partum adverse outcomes
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Number of neonatal deaths
timeFrame: Through study completion, an average of 1 year
measure: Incidence of low Birth Weight (LBW)
timeFrame: Through study completion, an average of 1 year
measure: Incidence of preterm birth
timeFrame: Through study completion, an average of 1 year
measure: Occurrence and description of malformations
timeFrame: Through study completion, an average of 1 year
measure: Occurrence of Small for Gestational Age (SGA)
timeFrame: Through study completion, an average of 1 year
measure: Occurrence of malaria (symptomatic and asymptomatic) in neonates and infants
timeFrame: Through study completion, an average of 1 year
measure: Occurrence of anemia during infancy at 6 and 12 months of age
timeFrame: Through study completion, an average of 1 year
measure: Occurrence of neonatal/infant/pediatric adverse outcomes
timeFrame: Through study completion, an average of 1 year
measure: Timing of receipt of routine vaccinations
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kalifabougou
country: Mali
facility: Kalifabougou MRTC Clinic
state: Région De Koulikoro
Study officials:
affiliation: Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)
name: Kassoum Kayentao, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institutes of Health (NIH)
name: Peter Crompton, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: