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Trial · NCT01443130

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of Placental Malaria Infection Based on HistologyAt delivery: Approximately 12-36 weeks after enrollment
The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue.
SecondaryIncidence of Placental Malaria by Placental Impression SmearAt delivery: Approximately 12-36 weeks after enrollment
Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results.
SecondaryIncidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter)From enrollment until delivery, approximately 12-36 weeks
Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL).
SecondaryIncidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl)From enrollment until delivery, approximately 12-36 weeks
Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl.
SecondaryIncidence of StillbirthAt delivery: Approximately 12-36 weeks after enrollment
Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation.
SecondaryIncidence of MiscarriageAt delivery: Approximately 12-36 weeks after enrollment
Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation.
SecondaryIncidence of Preterm DeliveryAt delivery: Approximately 12-36 weeks after enrollment
Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage.
SecondaryInfant Mortality Rate to 14 Weeks of AgeFor 14 weeks after delivery.Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery.
SecondaryIncidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams)At delivery: Approximately 12-36 weeks after enrollmentMaternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams.
SecondaryIncidence of Intrauterine Growth Restriction (IUGR)At delivery: Approximately 12-36 weeks after enrollment
Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar.
SecondaryIncidence of Active Placental Malaria InfectionAt delivery: Approximately 12-36 weeks after enrollment
Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of placental malaria infections in maternal subjects diagnosed by the presence of parasites and/or pigment on histological section or molecular evidence of infection (PCR).
SecondaryIncidence of Malaria Infection, All Species.Enrollment to delivery (approximately 12-36 weeks)Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of malaria infection episodes measured by positive parasitemia in maternal subjects.
SecondaryIncidence of Clinical Malaria, All SpeciesEnrollment to delivery (approximately 12-36 weeks)
Maternal participants were followed to outcome of the pregnancy. Clinical malaria is defined as malaria infection at any parasite density with associated symptoms including at least one of the following: objective fever measured at the clinic, history of fever in the past 48 hours or other symptoms in the last 48 hours including: headache, myalgia, vomiting, or weakness.
SecondaryIncidence of Infection in the Fetal CirculationAt delivery: Approximately 12-36 weeks after enrollment
Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of positive for malaria cord blood smear and cord PCR results in maternal subjects based on the results of the thick smear and PCR from the cord blood sample.

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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