Malaria Pregnancy and Childbirth
Conditions
Interventions
Testing in the 1st trimester with a malaria HsRdt
Standard ANC
Sponsors
Duke Clinical Research Institute
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Aged between 16 years and 40 years (inclusive) • Viable singleton pregnancy with gestational age estimated less than 13 6/7 weeks (inclusive) by ultrasound • HIV-uninfected • Willing to participate in the study schedule • Planning to remain in the study area for the duration of pregnancy and 1 month after delivery • Willing to deliver in a study-affiliated health facility
Exclusion criteria
Exclusion criteria: • High risk pregnancy that requires referral for specialized care by local guidelines • Active medical problem at the time of screening requiring higher level care • Antimalarial receipt in the 2 weeks prior to screening • Past allergy to Artemether or Lumefantrine or another condition that prohibits the receipt of either drug • Current participation in another clinical research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Low birth weight (<2500 grams) OR • Preterm (< 37 0/7 weeks) OR • Small for gestational age (GA) (< 10th percentile weight for GA) OR • Pregnancy loss, defined as a. Spontaneous abortion ( loss < 22 0/7 weeks gestation) OR b. Stillbirth (loss = 22 0/7 weeks gestation) OR • Neonatal death (livebirth with death prior to the 28th day of life) | — |
Secondary
| Measure | Time frame |
|---|---|
| Birthweight in grams;Low birthweight less than 2500g;Gestational age in weeks-days;Preterm less than 37 0/7 weeks;Small for gestational age less than 10th percentile;Adverse newborn outcome low birthweight or preterm or small for gestational age;Spontaneous abortion defined as pregnancy loss less than 22 0/7 weeks gestation;Stillbirth defined as pregnancy loss greater than or equal to 22 0/7 weeks gestation;Early fetal death defined as pregnancy loss between 22 0/7 and 27 6/7 weeks gestation;Late fetal death defined as pregnancy loss greater than or equal to 28 0/7 weeks gestation;Pregnancy loss defined as spontaneous abortion or stillbirth;Neonatal death, defined as a livebirth with death before the 28th day of life;Perinatal death, defined as late fetal death or neonatal death;Clinical malaria during pregnancy;Maternal peripheral parasitemia;Maternal hemoglobin concentration;Anemia, defined as hemoglobin concentration less than or equal to 11 g/dL;Severe anemia, defined as hemoglobin concentration less that or equal to 7 g/dL;Maternal SAEs;Congenital malformations;Hospitalization or acute medical evaluation of the offspring | — |
Countries
Democratic Republic of the Congo, Kenya
Contacts
Public ContactSteve Taylor
Duke University School of Medicine
Outcome results
None listed