Trial · NCT04336189
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Risk of Having a Composite Adverse Birth Outcome | Time from first dose of study drugs up to 28 days postpartum, an average of 6 months | Composite adverse birth outcome defined as the occurrence of any of the following: * Spontaneous abortion: Fetal loss at \< 28 weeks gestational age * Stillbirth: Infant born deceased at \> 28 weeks gestational age * Low Birth Weight (LBW): Live birth with birth weight \< 2500 gm * Preterm birth: Live birth at \< 37 weeks gestational age * Small-for-gestational age (SGA): Live birth with weight-for-gestational age \< 10th percentile of reference population * Neonatal death: Live birth with neonatal death within the first 28 days of life |
| Primary | Incidence of Serious Adverse Events (SAE) Per Time at Risk | Time from first dose of study drugs up to 28 days postpartum, an average of 6 months | SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables |
| Primary | Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk | Time from first dose of study drugs up to 28 days postpartum, an average of 6 months | Grade 3 and 4 AEs or SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables |
| Secondary | Number of Participants With Spontaneous Abortion | Time of delivery | Spontaneous abortion defined as fetal loss at \< 28 weeks gestational age |
| Secondary | Incidence of Anemia Adverse Event Per Time at Risk | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables |
| Secondary | Incidence of Grade 3-4 AEs Possibly Related to Study Drugs | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | Grade 3-4 AEs possibly or definitely related to study drug defined by the July 2017 NIH DAIDS Toxicity Tables |
| Secondary | Risk of Placental Malaria | At the time of delivery | Detection of malaria parasites or pigment by histopathology |
| Secondary | Incidence of Malaria During Pregnancy | Day study drugs first given until delivery, an average of 6 months | Episodes of symptomatic malaria (incidence per person year at risk following initiation of study drugs) |
| Secondary | Microscopic Parasitemia During Pregnancy | Day study drugs first given until delivery, an average of 6 months | Proportion of routine samples with asexual parasites detected by microscopy |
| Secondary | Prevalence of Anemia During Pregnancy | Day study drugs are first given until delivery | Proportion of routine hemoglobin measurements \< 11 g/dL |
| Secondary | Stillbirth | Time of delivery | Stillbirth defined as infant born deceased at \> 28 weeks gestational age |
| Secondary | Low Birth Rate | Time of delivery | Low birth weight defined as live birth with birth weight \< 2500 gm |
| Secondary | Preterm Delivery | Time of delivery | Preterm delivery defined as live birth at \< 37 weeks gestational age |
| Secondary | Small-for-gestational Age | Time of delivery | Small-for-gestational age defined as live birth with weight-for-gestational age \< 10th percentile of reference population |
| Secondary | Neonatal Death | Time of delivery | Neonatal death defined as live birth with neonatal death within the first 28 days of life |
| Secondary | Microscopic or Sub-microscopic Parasitemia During Pregnancy | Day study drugs first given until delivery, an average of 6 months | Proportion of routine samples with asexual parasites detected by microscopy or qPCR |
| Secondary | Prevalence of Severe Anemia During Pregnancy | Day study drugs are first given until delivery, an average of 6 months | Proportion of routine hemoglobin measurements \< 8 g/dL |
| Secondary | Incidence of Stillbirth Adverse Event Per Time at Risk | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables |
| Secondary | Incidence of Congenital Anomaly Adverse Event Per Time at Risk | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables |
| Secondary | Incidence of Neutropenia Adverse Event Per Time at Risk | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04336189/registered