Trial · NCT02163447
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prevalence of Placental Malaria | Delivery | Prevalence of placental malaria based on placental histopathology dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence and by histopathology as a categorical variable based on Rogerson et al criteria. |
| Primary | Incidence of Malaria in Pregnant Women | Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination | Incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. |
| Primary | Incidence of Malaria in Infants | Time 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) | Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age. |
| Primary | Incidence of Malaria in Infants | Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination | Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age. |
| Secondary | Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP | Delivery | Prevalence of placental blood samples positive for parasites by microscopy or LAMP |
| Secondary | Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery | At delivery | Prevalence of maternal parasitemia at delivery by microscopy and LAMP |
| Secondary | Number of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term Delivery | Delivery | Congenital malformations, spontaneous abortion, LBW (\<2500g), still birth, pre-term delivery |
| Secondary | Prevalence of Anemia in Pregnant Women | After first dose of study drugs up to delivery or early termination | Prevalence of routine hemoglobin measurements \< 11 g/dL |
| Secondary | Incidence of Complicated Malaria in Infants | Birth up to 24 months of age or early study termination | Any treatment for malaria meeting criteria for severe malaria or danger signs |
| Secondary | Incidence of Hospital Admissions in Infants | Birth up to 24 months of age or early study termination | Admission to a hospital for pediatric inpatient care for any reason |
| Secondary | Prevalence of Gametocytemia in Pregnant Women | Gestational age between 12-20 weeks (at study entry) up to delivery | Proportion of urgent blood smears positive for gametocytes |
| Secondary | Prevalence of Parasitemia in Infants | Birth up to 24 months of age or early study termination | Proportion of routine monthly samples positive for parasites by LAMP. Proportion of routine samples (LAMP or blood smears) positive for asexual parasites. |
| Secondary | Prevalence of Parasitemia at the Time of Monthly Routine Visits During Pregnancy | After first dose of study drug through delivery or early termination | Detection of malaria parasites by LAMP during pregnancy |
| Secondary | Prevalence of Gametocytemia in Infants | Birth up to 24 months of age or early study termination | Proportion of routine blood smears positive for gametocytes |
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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