Trial · NCT01103063
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population | Approximately 40 weeks of gestational age | Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (\<2,500 g), premature births (\<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (\>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. |
| Secondary | Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population | Approximately 40 weeks of gestational age | Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (\<2,500g), premature births (\<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (\>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. |
| Secondary | Percentage of Neonates With LBW (<2500 g) in ITT Population | Approximately 40 weeks of gestational age | LBW was defined as live birth weight \<2500 g (up to and including 2499 g). |
| Secondary | Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population | Approximately 40 weeks of gestational age | LBW was defined as live birth weight \<2500 g (up to and including 2499 g). |
| Secondary | Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation | At 36-38 weeks of gestation. | Severe maternal anemia was defined as Hb \<8 g/dL. |
| Secondary | Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation | At 36-38 weeks of gestation. | Anemia was defined as Hb \<11 g/dL. |
| Secondary | Percentage of Participants With Placental Parasitemia at Delivery | Approximately 40 weeks of gestational age | Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital. |
| Secondary | Percentage of Participants With Placental Malaria at Delivery Based on Histology | Approximately 40 weeks of gestational age | Participants positive for placental malaria at delivery were evaluated based on placental histology. |
| Secondary | Sexually Transmitted Infection (STI) Episodes Per Participant | Approximately 40 weeks of gestational age . | Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results). |
| Secondary | Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation | Approximately 40 weeks of gestational age. | Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight \<2,500g), premature birth (\<37 weeks), abortion (≤28 weeks), still birth (\>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. |
| Secondary | Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration. | Baseline, at 36-38 weeks of gestation. | Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted. |
| Secondary | Percentage of Neonates With Congenital Abnormalities at Birth | Approximately 40 weeks of gestational age. | Neonates with congenital abnormalities at birth were noted. |
| Secondary | Percentage of Perinatal or Neonatal Deaths | Day 28 after delivery. | Percentage of perinatal or neonatal deaths were noted. |
| Secondary | Birth Weight of Live Borne Neonate | Approximately 40 weeks of gestational age. | Birth weight of live borne neonates were calculated in grams. |
| Secondary | Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery | Approximately 40 weeks of gestational age | This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever \>37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria. |
| Secondary | Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery | Approximately 40 weeks of gestational age | This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results). |
| Secondary | Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation | At 36-38 weeks of gestation | This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0. |
| Secondary | Percentage of Participants With Peripheral Parasitemia at Delivery | Approximately 40 weeks of gestational age | This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0. |
| Secondary | Percentage of Participants With Cord Blood Parasitemia at Delivery | Approximately 40 weeks of gestational age | This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0. |
| Secondary | Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation | Upto 36-38 weeks of gestation | Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38. |
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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