CompletedPhase 3

Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa

Kenya, Malawi4,680 participantsStarted 2018-03-29

Plain-language 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.

Who can participate

Age range16 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Adverse pregnancy outcome

Timeframe: 8 months

Trial details

NCT IDNCT03208179

SponsorLiverpool School of Tropical Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-15

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