Kalifabougou MRTC Clinic
Kalifabougou, Koulikoro, Mali
Location status: Recruiting
Recruiting
NCT Number: NCT06468319
Pregnancy Registry in Mali
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
15 year–49 year
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Community Census Cohort:
- Females of childbearing potential or pregnant females.
- Aged 15 to 49 years.
- Able to provide verbal individual informed consent.
Health Facility Cohort:
- Pregnant females 15 to 49 years and their subsequent offspring.
- Resides in or in the health catchment area of Kalifabougou and willing to return to the health center for Antenatal Care (ANC) visits.
- Able to provide written individual informed consent for herself and her future offspring(s).
Exclusion criteria
Community Census Cohort:
- Temporary residence in the study area.
- 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:
- Temporary residence in the study area.
- 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.
Treatment and study plan
Primary outcomes
-
Number of pregnancies
Time frame: Through study completion, an average of 1 year
Detected by urine or serum by active and passive screening
-
Number of malaria cases
Time frame: 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
-
Incidence of placental malaria
Time frame: Through study completion, an average of 1 year
Detected by blood smear or pathology/histology, at delivery
-
Use of other malaria prevention tools
Time frame: Through study completion, an average of 1 year
Recorded by survey
-
Number of Participants with anemia during pregnancy and post-partum
Time frame: Through study completion, an average of 1 year
Defined as hemoglobin level less than 11 g/dL
-
Dating of pregnancies
Time frame: Through study completion, an average of 1 year
Measured at each ANC visit by ultrasound and last menstrual period
-
Number of Maternal Deaths
Time frame: Through study completion, an average of 1 year
-
Number of fetal Losses and Stillbirths
Time frame: 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
-
Number of multiple gestations
Time frame: Through study completion, an average of 1 year
Twins, triplets, or multiple gestations during pregnancy
-
Incidence of preterm delivery
Time frame: Through study completion, an average of 1 year
Preterm delivery (≥28 to <37 weeks)
-
Occurrence of chronic medical conditions
Time frame: 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
Time frame: 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
Secondary outcomes
-
Number of neonatal deaths
Time frame: Through study completion, an average of 1 year
Neonatal death as defined as early (≤7 days) or late (>7 days ≤28 days) after delivery
-
Incidence of low Birth Weight (LBW)
Time frame: Through study completion, an average of 1 year
LBW as defined as <2.5 kg at birth
-
Incidence of preterm birth
Time frame: Through study completion, an average of 1 year
Preterm birth (≥28 to <37 weeks)
-
Occurrence and description of malformations
Time frame: 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 Small for Gestational Age (SGA)
Time frame: 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
Time frame: 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
-
Occurrence of anemia during infancy at 6 and 12 months of age
Time frame: Through study completion, an average of 1 year
Anemia during infancy as defined by age of testing
-
Occurrence of neonatal/infant/pediatric adverse outcomes
Time frame: Through study completion, an average of 1 year
Description and reporting of occurrence of neonatal/infant/pediatric adverse outcomes
-
Timing of receipt of routine vaccinations
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Boubacar Traore, PharmD, PhD
CONTACT
Kassoum Kayentao, MD, MPH, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Nih
Collaborators
- National Institutes of Health (NIH)
- University of Washington
Registry information
Official study title
Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali
Important dates
- Study start
- 2024
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Jun 21, 2024
- Registry last updated
- Mar 13, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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