Pregnancy Registry in Mali

Recruiting

• Conditions: Pregnancy Related; Malaria

• Registration Number: NCT06468319
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-21
• Status Verified: 2024-08
• Study Start: 2024-08-05
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2030-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 9500

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).

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of fetal Losses and Stillbirths	Through study completion, an average of 1 year	Pregnancies terminated in the first trimester (\<=12 weeks) and in the second trimester (\>12 and \<28 weeks) and stillbirth
Incidence of preterm delivery	Through study completion, an average of 1 year	Preterm delivery (≥28 to \<37 weeks)
Occurrence of chronic medical conditions	Through study completion, an average of 1 year	Description and reporting of occurrence of chronic medical conditions during pregnancy and/or post-partum
Occurrence of pregnancy and post-partum adverse outcomes	Through study completion, an average of 1 year	Description and reporting of occurrence of pregnancy and post-partum adverse outcomes including but not limited to gestational diabetes, gestational hypertension, pre-eclampsia, eclampsia, postpartum hemorrhage, and postpartum depression
Number of malaria cases	Through study completion, an average of 1 year	Detected by RDT and/or blood smear and/or PCR during pregnancy defined as any parasitemia with or without malaria symptoms
Use of other malaria prevention tools	Through study completion, an average of 1 year	Recorded by survey
Number of Maternal Deaths	Through study completion, an average of 1 year
Dating of pregnancies	Through study completion, an average of 1 year	Measured at each ANC visit by ultrasound and last menstrual period
Number of pregnancies	Through study completion, an average of 1 year	Detected by urine or serum by active and passive screening
Incidence of placental malaria	Through study completion, an average of 1 year	Detected by blood smear or pathology/histology, at delivery
Number of Participants with anemia during pregnancy and post-partum	Through study completion, an average of 1 year	Defined as hemoglobin level less than 11 g/dL
Number of multiple gestations	Through study completion, an average of 1 year	Twins, triplets, or multiple gestations during pregnancy

Secondary Outcome Measures

Name	Time	Method
Number of neonatal deaths	Through study completion, an average of 1 year	Neonatal death as defined as early (≤7 days) or late (\>7 days ≤28 days) after delivery
Occurrence and description of malformations	Through study completion, an average of 1 year	Occurrence and description of malformations identified at delivery and within the first 6 months of life
Occurrence of neonatal/infant/pediatric adverse outcomes	Through study completion, an average of 1 year	Description and reporting of occurrence of neonatal/infant/pediatric adverse outcomes
Incidence of low Birth Weight (LBW)	Through study completion, an average of 1 year	LBW as defined as \<2.5 kg at birth
Incidence of preterm birth	Through study completion, an average of 1 year	Preterm birth (≥28 to \<37 weeks)
Timing of receipt of routine vaccinations	Through study completion, an average of 1 year	Reporting and timing of receipt of routine vaccinations, including malaria vaccines, and other standard of care anti-malarial treatment
Occurrence of anemia during infancy at 6 and 12 months of age	Through study completion, an average of 1 year	Anemia during infancy as defined by age of testing
Occurrence of Small for Gestational Age (SGA)	Through study completion, an average of 1 year	defined as newborns whose birth weight is \<10th percentile for gestational age as defined by INTERGROWTH-21st international standards
Occurrence of malaria (symptomatic and asymptomatic) in neonates and infants	Through study completion, an average of 1 year	Detected by RDT and/or blood smear and/or PCR at birth and throughout first year of life defined as any parasitemia with or without malaria symptoms

Trial Locations

Locations (1)

Kalifabougou MRTC Clinic; 🇲🇱 Kalifabougou, Région De Koulikoro, Mali