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Trial · NCT02163447

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPrevalence of Placental MalariaDeliveryOnly women who delivered and had histopathology results were analyzed. 2 women in 3 Dose SP and 1 woman in monthly DP arms completed the study but did not have histopathology results.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYIncidence of Malaria in Pregnant WomenTime at risk will begin after first dose of study drug and will end when study participants deliver or early study terminationevents per person yearsNUMBER
PRIMARYIncidence of Malaria in InfantsTime at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age)All live birthsEvents per person yearsNUMBER
PRIMARYIncidence of Malaria in InfantsTime at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or terminationAll live birthsEvents per person yearsNUMBER
SECONDARYNumber of Participants With Blood Samples Positive for Parasites by Microscopy or LAMPDeliveryParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at DeliveryAt delivery
One observation in the monthly DP arm did not have results for microscopy; this outcome measure tests blood taken from the mother's arm (different from outcome measure 4 which tests blood taken from the placenta)
participantsNUMBER
SECONDARYNumber of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term DeliveryDeliveryParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPrevalence of Anemia in Pregnant WomenAfter first dose of study drugs up to delivery or early terminationhemoglobin measurements taken every 12wkNUMBER
SECONDARYIncidence of Complicated Malaria in InfantsBirth up to 24 months of age or early study terminationAll live birthsEvents per person yearsNUMBER
SECONDARYIncidence of Hospital Admissions in InfantsBirth up to 24 months of age or early study terminationEvents per person yearsNUMBER
SECONDARYPrevalence of Gametocytemia in Pregnant WomenGestational age between 12-20 weeks (at study entry) up to deliveryPositive blood smearsNUMBER
SECONDARYPrevalence of Parasitemia in InfantsBirth up to 24 months of age or early study terminationPositive blood smearsNUMBER
SECONDARYPrevalence of Parasitemia at the Time of Monthly Routine Visits During PregnancyAfter first dose of study drug through delivery or early terminationPositive specimensNUMBER
SECONDARYPrevalence of Gametocytemia in InfantsBirth up to 24 months of age or early study terminationPositive blood smearsNUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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