NCT06468319|RecruitingDMC
Pregnancy Registry in Mali
Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali
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Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali
Sponsor study identifier
observational
9,500
1 country
1
Study Start
August 5, 2024
Actual (reported)Primary Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 28, 2024
Actual (reported)June 21, 2024
Actual (reported)August 5, 2024
Actual (reported)June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of pregnancies
Detected by urine or serum by active and passive screening
Through study completion, an average of 1 year
Number of malaria cases
Detected by RDT and/or blood smear and/or PCR during pregnancy defined as any parasitemia with or without malaria symptoms
Through study completion, an average of 1 year
Incidence of placental malaria
Detected by blood smear or pathology/histology, at delivery
Through study completion, an average of 1 year
Use of other malaria prevention tools
Recorded by survey
Through study completion, an average of 1 year
Number of Participants with anemia during pregnancy and post-partum
Defined as hemoglobin level less than 11 g/dL
Through study completion, an average of 1 year
Number of neonatal deaths
Through study completion, an average of 1 year
Incidence of low Birth Weight (LBW)
Through study completion, an average of 1 year
Incidence of preterm birth
Through study completion, an average of 1 year
Occurrence and description of malformations
Through study completion, an average of 1 year
Occurrence of Small for Gestational Age (SGA)
Through study completion, an average of 1 year
Women of child-bearing aged (WOCBA) identified within the community.
Pregnant women presenting at the health facility for antenatal care or referred in from the Community Consensus Cohort.
Children born to women in the health facility cohort.
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
Kalifabougou MRTC Clinic
Kalifabougou, Koulikoro, Mali
Whole blood collection for baseline hemoglobin and malaria infection status. Urine and/or serum collection for pregnancy test. Collection of placenta for malaria testing and pathology/histology. Cord blood collection for malaria infection status
Kassoum Kayentao, MD, MPH, PhD
Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)
Peter Crompton, MD, MPH
National Institutes of Health (NIH)
First Submitted
May 28, 2024
First Posted
June 21, 2024
Study Start
August 5, 2024
Actual (reported)Primary Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
L9LS-R21 Interaction
Dating of pregnancies
Measured at each ANC visit by ultrasound and last menstrual period
Through study completion, an average of 1 year
Number of Maternal Deaths
Through study completion, an average of 1 year
Number of fetal Losses and Stillbirths
Pregnancies terminated in the first trimester (\<=12 weeks) and in the second trimester (\>12 and \<28 weeks) and stillbirth
Through study completion, an average of 1 year
Number of multiple gestations
Twins, triplets, or multiple gestations during pregnancy
Through study completion, an average of 1 year
Incidence of preterm delivery
Preterm delivery (≥28 to \<37 weeks)
Through study completion, an average of 1 year
Occurrence of chronic medical conditions
Description and reporting of occurrence of chronic medical conditions during pregnancy and/or post-partum
Through study completion, an average of 1 year
Occurrence of pregnancy and post-partum adverse outcomes
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
Through study completion, an average of 1 year
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Study Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 13, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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