Pregnancy Clinical Trial
— INTREPiDOfficial title:
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity
The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth weight, small for gestational age, preterm, fetal loss, or neonatal death.
Status | Recruiting |
Enrollment | 2500 |
Est. completion date | April 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 40 Years |
Eligibility | 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: - 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 |
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic of the | Kinshasa School of Public Health | Kinshasa | |
Kenya | Moi University | Eldoret |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute of Allergy and Infectious Diseases (NIAID) |
Congo, The Democratic Republic of the, Kenya,
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Walker PG, ter Kuile FO, Garske T, Menendez C, Ghani AC. Estimated risk of placental infection and low birthweight attributable to Plasmodium falciparum malaria in Africa in 2010: a modelling study. Lancet Glob Health. 2014 Aug;2(8):e460-7. doi: 10.1016/S2214-109X(14)70256-6. Epub 2014 Jul 23. — View Citation
* Note: There are 57 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of maternal serious adverse events | Serious adverse events in the mothers | Enrollment to 28 days Post-delivery | |
Other | Number of infants with congenital malformations | Congenital malformations identified within the first 28 days of birth | Delivery to 28 days Post-delivery | |
Other | Number of offspring with the need for hospitalization or acute medical evaluation | Hospitalization or acute medical evaluation within the first 28 days of life | Delivery to 28 days Post-delivery | |
Primary | Composite number of adverse pregnancy outcomes | Adverse pregnancy outcomes defined as 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). | Enrollment to 28 days Post-delivery (including each antenatal care visit) | |
Secondary | Birthweight | Birthweight in grams | Delivery | |
Secondary | Number of infants with low birthweight | < 2500 grams, livebirth | Delivery | |
Secondary | Gestational age (GA) | GA at delivery in weeks/days, livebirth | Delivery | |
Secondary | Preterm | < 37 0/7 weeks, livebirth | Delivery | |
Secondary | Number of infants that are small for gestational age | Weight for gestational age < 10th percentile, livebirth | Delivery | |
Secondary | Number of adverse newborn outcomes | low birthweight OR preterm OR small for gestational age | Delivery | |
Secondary | Number of spontaneous abortions | Pregnancy loss < 22 0/7 weeks gestation | Delivery | |
Secondary | Number of stillbirths | Pregnancy loss = 22 0/7 weeks gestation | Delivery | |
Secondary | Number of early fetal deaths | Pregnancy loss 22 0/7 - 27 6/7 weeks gestation | Delivery | |
Secondary | Number of late fetal deaths | Pregnancy loss = 28 0/7 weeks gestation | Delivery | |
Secondary | Number of pregnancy losses | Spontaneous abortion OR stillbirth | Delivery | |
Secondary | Number of neonatal deaths | Before the 28th day of life, livebirth | Delivery to 28 days Post-delivery | |
Secondary | Number of perinatal deaths | Late fetal death OR Neonatal death | Delivery to 28 days Post-delivery | |
Secondary | Incidence of clinical malaria during pregnancy | Maternal symptoms with peripheral malaria parasitemia detected by light microscopy or rapid diagnostic test | Enrollment to Delivery (including each antenatal care visit) | |
Secondary | Number of mothers with peripheral parasitemia at delivery | Maternal peripheral parasitemia at delivery by PCR | Delivery | |
Secondary | Mean maternal hemoglobin concentration | Maternal hemoglobin (g/dL) | Enrollment and Delivery | |
Secondary | Number of mothers with anemia at delivery | Maternal Hb concentration = 11 g/dL | Delivery | |
Secondary | Number of mothers with severe anemia at delivery | Maternal Hb concentration = 7 g/dL | Delivery |
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