Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics (INTREPiD)

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2023
INTERVENTION: Standard ANC Testing in the 1st trimester with a malaria HsRdt CONDITION: ; Malaria ; Pregnancy and Childbirth Malaria Pregnancy and Childbirth PRIMARY OUTCOME: • 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 OUTCOME: Adverse newborn outcome low birthweight or preterm or small for gestational age Anemia, defined as hemoglobin concentration less than or equal to 11 g/dL Birthweight in grams Clinical malaria during pregnancy Congenital malformations Early fetal death defined as pregnancy loss between 22 0/7 and 27 6/7 weeks gestation Gestational age in weeks‐days Hospitalization or acute medical evaluation of the offspring Late fetal death defined as pregnancy loss greater than or equal to 28 0/7 weeks gestation Low birthweight less than 2500g Maternal hemoglobin concentration Maternal peripheral parasitemia Maternal SAEs Neonatal death, defined as a livebirth with death before the 28th day of life Perinatal death, defined as late fetal death or neonatal death Pregnancy loss defined as spontaneous abortion or stillbirth Preterm less than 37 0/7 weeks Severe anemia, defined as hemoglobin concentration less that or equal to 7 g/dL Small for gestational age less than 10th percentile 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 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
Epistemonikos ID: 45c736e1b9a0b53fa36c2e683d1921bb14618136
First added on: Feb 20, 2024