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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of Washington | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Census Cohort | Women of child-bearing aged (WOCBA) identified within the community. | ||
| Health Facility Cohort | Pregnant women presenting at the health facility for antenatal care or referred in from the Community Consensus Cohort. | ||
| Offspring from Health Facility Cohort | Children born to women in the health facility cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Community Census Cohort:
Health Facility Cohort:
Exclusion Criteria:
Community Census Cohort:
Health Facility Cohort:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kassoum Kayentao, MD, MPH, PhD | Contact | +223 7646 0173 | kayentao@icermali.org | |
| Boubacar Traore, PharmD, PhD | Contact | +223 20 22 14 17 | bouba.traore@mrtcbko.org |
| Name | Affiliation | Role |
|---|---|---|
| Kassoum Kayentao, MD, MPH, PhD | Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS) | Principal Investigator |
| Peter Crompton, MD, MPH | National Institutes of Health (NIH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kalifabougou MRTC Clinic | Recruiting | Kalifabougou | Koulikoro | Mali |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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Whole blood collection for baseline hemoglobin and malaria infection status. Urine and/or serum collection for pregnancy test. Collection of placenta for malaria testing and pathology/histology. Cord blood collection for malaria infection status
| 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 |
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 |
| D000079426 |
| Vector Borne Diseases |