Trial · NCT02518594
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation | From randomization to 35 weeks gestation (a period of up to 19 weeks) | Number of Participants who had preterm delivery or fetal loss of either twin prior to 35 weeks gestation |
| Secondary | Days From Randomization to Delivery (or Fetal Demise) | Randomization to delivery (a period of up to 26 weeks) | Days from the time of randomization (16-23 weeks gestation) to delivery or death of the fetus. |
| Secondary | Gestational Age at Delivery or Fetal Death | Randomization to delivery (a period of up to 26 weeks) | Gestational age at the time of delivery or death |
| Secondary | Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 28 Weeks Gestation | From randomization to up to 28 weeks gestation (a period if up to 12 weeks) | Preterm delivery or fetal loss of either twin prior to 28 weeks gestation |
| Secondary | Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation | From randomization to 32 weeks gestation (a period of up to 16 weeks) | Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation |
| Secondary | Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation | randomization to 37 weeks gestation (a period of up to 21 weeks) | Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation |
| Secondary | Number of Participants With Spontaneous Preterm Delivery < 32 Weeks Gestation | randomization to 32 weeks gestation (a period of up to 16 weeks) | Spontaneous preterm delivery (following preterm labor or pPROM) before 32 weeks gestation |
| Secondary | Number of Participants With Spontaneous Preterm Delivery < 35 Weeks Gestation | randomization to 35 weeks gestation (a period of up to 19 weeks) | Spontaneous preterm delivery (following preterm labor or pPROM) before 35 weeks gestation |
| Secondary | Number of Participants With Indicated Preterm Delivery for < 35 Weeks | randomization to 35 weeks gestation (a period of up to 19 weeks) | Preterm delivery prior to 35 weeks gestation with medical indications |
| Secondary | Number of Participants With Cesarean Delivery | Randomization to delivery (a period of up to 26 weeks) | Delivery by cesarean |
| Secondary | Number of Fetal, Neonatal or Infant Deaths | From randomization to up to 28 days post birth (a period of up to 30 weeks) | Number of fetal, neonatal or infant deaths |
| Secondary | Number of Neonates Small for Gestational Age < 5th Percentile | randomization to delivery (a period of up to 26 weeks) | The number of neonates whose birthweight compared with gestational age at delivery was less than the 5th percentile, as assessed by sex and race, using United States birth certificate data. |
| Secondary | Number of Neonates With the Composite Neonatal Outcome | Birth to neonatal discharge or death, whichever is first (up to 70 weeks) | The number of neonates diagnosed with any one of fetal or neonatal death or Respiratory Distress Syndrome, Grade 3 or 4 Intraventricular Hemorrhage, Periventricular Leukomalacia, Stage 2 or 3 Necrotizing Enterocolitis, Bronchopulmonary Dysplasia, Stage III or higher Retinopathy of Prematurity, or early onset sepsis. IVH grades III or IV are as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papile classification system. The number of neonates diagnosed with NEC, defined as modified Bell Stage 2 or 3 where stage 2 represents clinical signs and symptoms with pneumatosis intestinalis on radiographs and stage 3 is defined as advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation. The stages of Retinopathy of Prematurity range from 1 (mild) to 5 (severe). |
| Secondary | Number of Neonates Admitted to Intensive Care (NICU) or Intermediate Care | Birth to the time of NICU or Intermediate Care Admission, whichever came first (a maximum of 10 days) | The number of neonates admitted to intensive care (NICU) or intermediate care out of all liveborn infants. |
| Secondary | Length of Neonatal Hospital Stay in Days | admission to hospital discharge (a median of 12 days with a maximum of 490 days) | Number of days the neonate was in the hospital |
| Secondary | Length of Stay in Neonatal Intensive Care (NICU) or Intermediate Care in Days | admission to discharge from NICU or intermediate care (a median of 28 days, with a maximum of 491 days) | Length of stay in neonatal intensive care (NICU) or intermediate care |
| Other | Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation by Race/Ethnicity | From randomization to 35 weeks gestation (a period of up to 19 weeks) | NIH-required analysis. Number of participants who had preterm delivery or fetal loss of either twin prior to 35 weeks gestation |
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/NCT02518594/registered