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

Phase 4

• Conditions: Malaria; Pregnancy and Childbirth

• Registration Number: PACTR202302536807007
• Lead Sponsor: Duke Clinical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 2500

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified