Improving neonatal health by testing for malaria in early pregnancy
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity
This study is testing if screening for malaria in early pregnancy can help improve the health of mothers and their babies in areas where malaria is common.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Locations | 2 sites (Kinshasa and 1 other locations) |
| Trial ID | NCT05757167 on ClinicalTrials.gov |
What this trial studies
The INTREPiD study aims to evaluate the effectiveness of screening for malaria parasites in the first trimester of pregnancy using a high-sensitivity rapid diagnostic test. Women presenting to antenatal clinics in malaria-endemic regions of Kenya and the Democratic Republic of the Congo will be randomly assigned to either usual antenatal care or the intervention group, which includes screening and treatment with Artemether-Lumefantrine if malaria is detected. The study will follow participants through delivery and into their offspring's first month of life to assess the impact on adverse pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates are HIV-uninfected women aged 16 to 40 years with a viable singleton pregnancy in the first trimester.
Not a fit: Patients with high-risk pregnancies requiring specialized care or those with recent antimalarial treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce adverse pregnancy outcomes associated with malaria in pregnant women.
How similar studies have performed: Other studies have shown promising results with similar malaria screening approaches, indicating potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kinshasa and 1 other locations
- Kinshasa School of Public Health — Kinshasa, Congo, The Democratic Republic of the (Recruiting)
- Moi University — Eldoret, Kenya (Recruiting)
Study contacts
- Principal investigator: Steve M Taylor, MD, MPH — Duke University
- Study coordinator: Stephen James, MPH
- Email: stephen.james@duke.edu
- Phone: 919-668-0420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.