Status:
ACTIVE_NOT_RECRUITING
Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment in Pregnancy
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
Papua New Guinea Institute of Medical Research
University of Melbourne
Conditions:
Malaria
Malaria in Pregnancy
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief Summary
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) plus dihydroartemisinin-piperaquine (DP) significantly reduces the risk o...
Detailed Description
Plasmodium falciparum and P. vivax infections cause malaria, maternal anemia and interfere with the development of the fetus, thereby increasing the risks of adverse pregnancy outcomes such as miscarr...
Eligibility Criteria
Inclusion
- Pregnant women between 12-26 weeks' gestation
- 16 years of age or older
- Viable singleton intrauterine pregnancy
- Permanent resident of the study area
- Willing to adhere to scheduled and unscheduled study visit procedures
- Willing to birth in a study clinic or hospital
- Able to provide written informed consent
Exclusion
- Multiple pregnancy (i.e. twins/triplets)
- Known heart ailment or other chronic medical condition requiring frequent hospital care
- Active medical problem requiring inpatient evaluation at the time of screening
- Severe malformations or non-viable pregnancy if observed by ultrasound
- Antimalarial therapy in the prior two weeks
- Unable to provide written informed consent
- Known allergy or contraindication to any of the study drugs
- Early or active labour
- Known HIV-positive status
Key Trial Info
Start Date :
August 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1172 Patients enrolled
Trial Details
Trial ID
NCT05426434
Start Date
August 31 2022
End Date
December 1 2025
Last Update
June 6 2025
Active Locations (1)
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1
Papua New Guinea Institute of Medical Research
Madang, Madang Province, Papua New Guinea, 511