Status:
COMPLETED
Comparison of ISTp- PYRAMAX-US-RDT to IPTp-SP to Prevent Malaria in Pregnant Women in DRC (ULTRAPYRAPREG)
Lead Sponsor:
University of Kinshasa
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Novartis
Conditions:
Malaria in Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
In endemic settings Plasmodium falciparum (Pf) can sequester in the placenta resulting in low peripheral parasitemia and false negative malaria diagnosis in pregnant women. Intermittent Preventive Tre...
Detailed Description
1\. Introduction Malaria is a threat for pregnant women and their offspring in endemic settings (1, 2). Plasmodium falciparum (Pf) can sequester in the placenta during pregnancy, resulting in low peri...
Eligibility Criteria
Inclusion
- Gestation ≥16 weeks;
- Age: ≥18 years;
- Residence within the health facility catchment area;
- Willing to adhere to study requirements and to deliver at the health facility.
- Willing to provide written informed consent; if the woman is illiterate, she can choose an impartial witness, not related to the study, to accompany her during the informant consent process and they will both sign the informed consent form
Exclusion
- Known history of allergy to SP or to an ACT
- An ongoing antibioprophylaxis with cotrimoxazole,
- Current issue requiring hospital admission (including severe malaria as defined by WHO)
- Pregnancy at high risk
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04783051
Start Date
May 6 2021
End Date
June 22 2022
Last Update
November 4 2022
Active Locations (1)
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1
Maternité Esengo
Kinshasa, Democratic Republic of the Congo