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Clinical Trials/PACTR202302536807007
PACTR202302536807007
Not yet recruiting
Phase 4

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

Duke Clinical Research Institute0 sites2,500 target enrollmentFebruary 23, 2023
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ConditionsMalariaPregnancy and Childbirth

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Malaria
Sponsor
Duke Clinical Research Institute
Enrollment
2500
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 23, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

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
  • •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

Outcomes

Primary Outcomes

Not specified

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