Clinical trial NCT05757167: Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Official title: Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Malaria,Falciparum
Malaria in Pregnancy
Malaria in Childbirth
Pregnancy
Neonatal Health
Low Birthweight
Stillbirth
Gestational Age and Weight Conditions
Preterm Birth
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-03-07
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment to either a) usual antenatal care or b) testing for malaria with a high-sensitivity rapid diagnostic test followed by treatment with artemether-lumefantrine if tested positive
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: INTREPiD is a two-arm, open-label, parallel-assignment randomized trial of a strategy of 1st trimester screening for P. falciparum parasites with a high-sensitivity rapid diagnostic test (HS-RDT). Participants will be women of all gravidities presenting to antenatal clinics in the 1st trimester in sites endemic for P. falciparum malaria in Kenya and the Democratic Republic of the Congo.

Following consent and enrollment, women will be allocated 1:1 to either usual antenatal care or to the intervention. The intervention will be a single screening in the 1st trimester for P. falciparum infection in maternal peripheral blood with a HS-RDT. Women who test positive for P. falciparum on HS-RDT testing will be treated with a single course of Artemether-Lumefantrine (AL) and then returned to usual antenatal care.

Participants will be followed through delivery and then through their offspring's first month of life.

The Hypothesis is that, compared to usual antenatal care, screening women in the 1st trimester for P. falciparum and treating them if positive with AL will reduce the risk of an adverse pregnancy outcome.

Eligibility 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:

* 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

Primary outcomes:
measure: Composite number of adverse pregnancy outcomes
timeFrame: Enrollment to 28 days Post-delivery (including each antenatal care visit)
Secondary outcomes:
measure: Birthweight
timeFrame: Delivery
measure: Number of infants with low birthweight
timeFrame: Delivery
measure: Gestational age (GA)
timeFrame: Delivery
measure: Preterm
timeFrame: Delivery
measure: Number of infants that are small for gestational age
timeFrame: Delivery
measure: Number of adverse newborn outcomes
timeFrame: Delivery
measure: Number of spontaneous abortions
timeFrame: Delivery
measure: Number of stillbirths
timeFrame: Delivery
measure: Number of early fetal deaths
timeFrame: Delivery
measure: Number of late fetal deaths
timeFrame: Delivery
measure: Number of pregnancy losses
timeFrame: Delivery
measure: Number of neonatal deaths
timeFrame: Delivery to 28 days Post-delivery
measure: Number of perinatal deaths
timeFrame: Delivery to 28 days Post-delivery
measure: Incidence of clinical malaria during pregnancy
timeFrame: Enrollment to Delivery (including each antenatal care visit)
measure: Number of mothers with peripheral parasitemia at delivery
timeFrame: Delivery
measure: Mean maternal hemoglobin concentration
timeFrame: Enrollment and Delivery
measure: Number of mothers with anemia at delivery
timeFrame: Delivery
measure: Number of mothers with severe anemia at delivery
timeFrame: Delivery
Other outcomes:
measure: Number of maternal serious adverse events
timeFrame: Enrollment to 28 days Post-delivery
measure: Number of infants with congenital malformations
timeFrame: Delivery to 28 days Post-delivery
measure: Number of offspring with the need for hospitalization or acute medical evaluation
timeFrame: Delivery to 28 days Post-delivery
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health
city: Eldoret
country: Kenya
facility: Moi University
Study officials:
affiliation: Duke University
name: Steve M Taylor, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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