Malaria, Pregnancy Related
Conditions
Brief summary
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.
Detailed description
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.
Interventions
None listed
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Community Census Cohort: 1. Females of childbearing potential or pregnant females. 2. Aged 15 to 49 years. 3. Able to provide verbal individual informed consent. Health Facility Cohort: 1. Pregnant females 15 to 49 years and their subsequent offspring. 2. Resides in or in the health catchment area of Kalifabougou and willing to return to the health center for Antenatal Care (ANC) visits. 3. Able to provide written individual informed consent for herself and her future offspring(s).
Exclusion criteria
Community Census Cohort: 1. Temporary residence in the study area. 2. 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: 1. Temporary residence in the study area. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of other malaria prevention tools | Through study completion, an average of 1 year | Recorded by survey |
| Number of pregnancies | Through study completion, an average of 1 year | Detected by urine or serum by active and passive screening |
| Number of malaria cases | 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 | Through study completion, an average of 1 year | Detected by blood smear or pathology/histology, at delivery |
| Number of Participants with anemia during pregnancy and post-partum | Through study completion, an average of 1 year | Defined as hemoglobin level less than 11 g/dL |
| Dating of pregnancies | Through study completion, an average of 1 year | Measured at each ANC visit by ultrasound and last menstrual period |
| Number of Maternal Deaths | Through study completion, an average of 1 year | — |
| Number of fetal Losses and Stillbirths | 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 | Through study completion, an average of 1 year | Twins, triplets, or multiple gestations during pregnancy |
| Incidence of preterm delivery | Through study completion, an average of 1 year | Preterm delivery (≥28 to \<37 weeks) |
| Occurrence of chronic medical conditions | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of neonatal deaths | 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) | Through study completion, an average of 1 year | LBW as defined as \<2.5 kg at birth |
| Incidence of preterm birth | Through study completion, an average of 1 year | Preterm birth (≥28 to \<37 weeks) |
| Occurrence and description of malformations | 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) | 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 | 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 | Through study completion, an average of 1 year | Anemia during infancy as defined by age of testing |
| Occurrence of neonatal/infant/pediatric adverse outcomes | 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 | 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 |
Countries
Mali
Contacts
CONTACTKassoum Kayentao, MD, MPH, PhD
CONTACTBoubacar Traore, PharmD, PhD
PRINCIPAL_INVESTIGATORKassoum Kayentao, MD, MPH, PhD
Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)
PRINCIPAL_INVESTIGATORPeter Crompton, MD, MPH
National Institutes of Health (NIH)
Outcome results
None listed