| Protocol No: | ECCT/23/02/03 | Date of Protocol: | 01-08-2022 |
| Study Title: |
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy with High-Sensitivity Diagnostics (INTREPiD).
|
| Study Objectives: |
The objective of INTREPiD is to test the effect on pregnancy outcome in P. falciparumendemic areas of a strategy of 1st trimester screening for P. falciparum parasites with a high-sensitivity rapid diagnostic test.
3.2.1 Primary
The primary objective of INTREPiD is to test if, compared to usual ANC, a strategy of 1st trimester screening of pregnant women with an HS-RDT for P. falciparum infection followed by treatment if positive with Artemether-Lumefantrine reduces the risk of an adverse pregnancy outcome.
3.2.2 Secondary
Secondary objectives of INTREPiD are to test if 1st trimester screening with an HS-RDT and treatment if positive with AL reduces the risks of an array of maternal, fetal, and safety outcomes (see Section 3.3.2).
|
| Laymans Summary: | INTREPiD is a randomized clinical trial of malaria testing during the 1st trimester of pregnancy. The study will test if we can improve pregnancy outcomes using a strategy of screening in the 1st trimester for malaria parasites using new malaria rapid diagnostic tests and treating the infected women. The goal of this trial is to identify new interventions to prevent the consequences of antenatal malaria during the important 1st trimester. |
| Abstract of Study: |
Study Design: An open-label, parallel-assignment, randomized clinical trial of 1sttrimester active screening for malaria parasites on adverse pregnancy outcome.
Study Phase: 4
Study Population: Pregnant women in the 1st trimester of all gravidities in areas of moderate to high P. falciparum transmission the intensity in Kenya and the Democratic Republic of the Congo. A total of >2000 women (# paucigravidae for primary analysis: 1368).
Number of Sites: 2: Kenya and DRC
Description of Study Product or Intervention: Testing capillary blood for P. falciparum parasites using a high-sensitivity rapid diagnostic test (HS-RDT)
Study Objectives: Primary: Composite adverse pregnancy outcome of: low birthweight (LBW, < 2500 g) or preterm (PT, <37 0/7 wk) or small for gestational age (SGA, < 10th percentile for gestational age) or pregnancy loss or neonatal death (live birth with death < 28d) Secondary: Individual components of the primary outcome, birthweight (continuous), gestational age (continuous), adverse newborn outcome (live birth with LBW/PT/SGA), perinatal mortality (stillbirth or neonatal death), neonatal death (live birth with death < 28d), malaria at delivery and maternal malaria.
Duration of Individual Subject Participation: Up to 42 weeks: up to 38 weeks gestation + 4 weeks postdelivery
Estimated Time to Last Subject/Last Study Day: 2 year
|