Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 4
- 主要终点
- Composite number of adverse pregnancy outcomes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HS-RDT screening/AL treatment
Pregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine
干预措施: Artemether-lumefantrine (AL) (Drug)
HS-RDT screening/AL treatment
Pregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine
干预措施: Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT) (Diagnostic Test)
结局指标
主要结局
Composite number of adverse pregnancy outcomes
时间窗: Enrollment to 28 days Post-delivery (including each antenatal care visit)
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).
次要结局
- Number of neonatal deaths(Delivery to 28 days Post-delivery)
- Birthweight(Delivery)
- Number of infants that are small for gestational age(Delivery)
- Number of perinatal deaths(Delivery to 28 days Post-delivery)
- Preterm(Delivery)
- Number of early fetal deaths(Delivery)
- Number of pregnancy losses(Delivery)
- Number of mothers with anemia at delivery(Delivery)
- Number of infants with low birthweight(Delivery)
- Number of adverse newborn outcomes(Delivery)
- Incidence of clinical malaria during pregnancy(Enrollment to Delivery (including each antenatal care visit))
- Mean maternal hemoglobin concentration(Enrollment and Delivery)
- Number of mothers with severe anemia at delivery(Delivery)
- Gestational age (GA)(Delivery)
- Number of spontaneous abortions(Delivery)
- Number of stillbirths(Delivery)
- Number of late fetal deaths(Delivery)
- Number of mothers with peripheral parasitemia at delivery(Delivery)