Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa

• Status: Completed
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: Female

Summary

This study evaluates the efficacy and safety of monthly intermittent preventive treatment using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ) compared to sulphadoxine-pyrimethamine (SP) for the prevention of malaria in pregnant women in the second and third trimester.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Liverpool School of Tropical Medicine
• Collaborators: Centers for Disease Control and Prevention; Foundation for Innovative New Diagnostics, Switzerland; Kenya Medical Research Institute; Kilimanjaro Christian Medical Centre, Tanzania; London School of Hygiene and Tropical Medicine; Malawi-Liverpool-Wellcome Trust Clinical Research Programme; National Institute for Medical Research, Tanzania; PATH; Tampere University; University College, London; University of Bergen; University of Copenhagen; University of Malawi College of Medicine; University of Massachusetts, Worcester; University of Melbourne; University of Toronto
• Treatments: Artemisinins; Artenimol; Azithromycin; Dihydroartemisinin; Fanasil, pyrimethamine drug combination; Piperaquine; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Pregnant women between 16-28 weeks' gestation

• Viable singleton pregnancy

• Resident of the study area

• Willing to adhere to scheduled and unscheduled study visit procedures

• Willing to deliver in a study clinic or hospital

• Provide written informed consent

Exclusion Criteria:

• Multiple pregnancies (i.e. twin/triplets)

• HIV-positive

• Known heart ailment

• Severe malformations or non-viable pregnancy if observed by ultrasound

• History of receiving IPTp-SP during this current pregnancy

• Unable to give consent

• Known allergy or contraindication to any of the study drugs