Pregnancy Registry in Mali
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-49
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Females of childbearing potential or pregnant females.
Aged 15 to 49 years.
Able to provide verbal individual informed consent.
Pregnant females 15 to 49 years and their subsequent offspring.
Disqualifiers
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.
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.
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
9,500 Participants
are grouped into 3 trial groupsGroup A: Community Census Cohort
Group B: Health Facility Cohort
Group C: Offspring from Health Facility Cohort
Trial outcomes
Primary outcomes
1
Number of pregnancies
Detected by urine or serum by active and passive screening
Time frame
Through study completion, an average of 1 year2
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 year3
Incidence of placental malaria
Detected by blood smear or pathology/histology, at delivery
Time frame
Through study completion, an average of 1 year4
Use of other malaria prevention tools
Recorded by survey
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
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 year2
Incidence of low Birth Weight (LBW)
LBW as defined as \<2.5 kg at birth
Time frame
Through study completion, an average of 1 year3
Incidence of preterm birth
Preterm birth (≥28 to \<37 weeks)
Time frame
Through study completion, an average of 1 year4
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
National Institutes of Health (NIH)
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov