Pregnancy Registry in Mali
NCT Number: NCT06468319
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Malaria|Pregnancy Related
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: National Institutes of Health (NIH)|University of Washington
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 9500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-05
Completion Date: 2030-06
Locations: Kalifabougou MRTC Clinic, Kalifabougou, Région De Koulikoro, Mali

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

Primary Outcome Measures: 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|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
Secondary Outcome Measures: Number of neonatal deaths, Neonatal death as defined as early (≤7 days) or late (\>7 days ≤28 days) after delivery, Through study completion, an average of 1 year|Incidence of low Birth Weight (LBW), LBW as defined as \<2.5 kg at birth, Through study completion, an average of 1 year|Incidence of preterm birth, Preterm birth (≥28 to \<37 weeks), Through study completion, an average of 1 year|Occurrence and description of malformations, Occurrence and description of malformations identified at delivery and within the first 6 months of life, Through study completion, an average of 1 year|Occurrence of Small for Gestational Age (SGA), defined as newborns whose birth weight is \<10th percentile for gestational age as defined by INTERGROWTH-21st international standards, Through study completion, an average of 1 year|Occurrence of malaria (symptomatic and asymptomatic) in neonates and infants, 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, Through study completion, an average of 1 year|Occurrence of anemia during infancy at 6 and 12 months of age, Anemia during infancy as defined by age of testing, Through study completion, an average of 1 year|Occurrence of neonatal/infant/pediatric adverse outcomes, Description and reporting of occurrence of neonatal/infant/pediatric adverse outcomes, Through study completion, an average of 1 year|Timing of receipt of routine vaccinations, Reporting and timing of receipt of routine vaccinations, including malaria vaccines, and other standard of care anti-malarial treatment, Through study completion, an average of 1 year