An observational study in Malaria and Pregnancy Related, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 1 site in Mali. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 9,500 is above the median of 582 across 204 observational studies indexed under Malaria.
Browse Malaria studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Community Census Cohort:
Health Facility Cohort:
Exclusion Criteria:
Community Census Cohort:
Health Facility Cohort:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Number of pregnancies
Detected by urine or serum by active and passive screening
Time frame: 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
Time frame: Through study completion, an average of 1 year
Incidence of placental malaria
Detected by blood smear or pathology/histology, at delivery
Time frame: Through study completion, an average of 1 year
Use of other malaria prevention tools
Recorded by survey
Time frame: 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
Time frame: Through study completion, an average of 1 year
Dating of pregnancies
Measured at each ANC visit by ultrasound and last menstrual period
Time frame: Through study completion, an average of 1 year
Number of Maternal Deaths
Time frame: 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
Time frame: Through study completion, an average of 1 year
Number of multiple gestations
Twins, triplets, or multiple gestations during pregnancy
Time frame: Through study completion, an average of 1 year
Incidence of preterm delivery
Preterm delivery (≥28 to \<37 weeks)
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 year
Number of neonatal deaths
Neonatal death as defined as early (≤7 days) or late (\>7 days ≤28 days) after delivery
Time frame: Through study completion, an average of 1 year
Incidence of low Birth Weight (LBW)
LBW as defined as \<2.5 kg at birth
Time frame: Through study completion, an average of 1 year
Incidence of preterm birth
Preterm birth (≥28 to \<37 weeks)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided
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