Trial · NCT03976063
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 | Perinatal morti-morbidity | Up to discharge from hospital, with a maximum of 24 weeks after birth. | Composite outcome including fetal death, neonatal death and/or neonatal severe morbidity (mechanical ventilation ≥ 48 hrs, severe bronchopulmonary dysplasia, severe intraventricular hemorrhage, cystic periventricular leucomalacia, neonatal early-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity). |
| Secondary | Prolongation of gestation | Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Latency duration (defined as the duration from PPROM to delivery) |
| Secondary | Prolongation of gestation | Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Pregnancy prolongation beyond 48 hours after randomization |
| Secondary | Prolongation of gestation | Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Pregnancy prolongation beyond 1 week after randomization |
| Secondary | Prolongation of gestation | Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Gestational age at delivery |
| Secondary | Prolongation of gestation | Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Delivery after 37 weeks of gestation |
| Secondary | Maternal morbidity | During the first 10 days postpartum | Endometritis, based on clinical diagnosis associating fever (temperature ≥ 38.0°C) with uterine tenderness, purulent or foul-smelling lochia, and in the absence of any other cause. |
| Secondary | Maternal morbidity | At delivery | Intra-uterine infection, defined as fever (maternal temperature ≥38 °C), with no alternative cause identified, associated with at least two of the following criteria: persistent fetal tachycardia \> 160 bpm, uterine pain or painful uterine contractions or spontaneous labor, purulent amniotic fluid. |
| Secondary | Fetal mortality | Up to delivery so up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Fetal death |
| Secondary | Neonatal mortality | From birth to discharge from hospital, with a maximum of 24 weeks after birth. | Neonatal death |
| Secondary | Neonatal severe morbidity | From birth to discharge from hospital, with a maximum of 24 weeks after birth. | Mechanical ventilation ≥ 48 hrs |
| Secondary | Neonatal severe morbidity | From birth to discharge from hospital, with a maximum of 24 weeks after birth. | Severe bronchopulmonary dysplasia |
| Secondary | Neonatal severe morbidity | From birth to discharge from hospital, with a maximum of 24 weeks after birth. | Severe intraventricular hemorrhage |
| Secondary | Neonatal severe morbidity | From birth to discharge from hospital, with a maximum of 24 weeks after birth. | Cystic periventricular leucomalacia |
| Secondary | Neonatal severe morbidity | From birth to Day 3 after birth. | Early-onset sepsis |
| Secondary | Neonatal severe morbidity | From birth to discharge from hospital, with a maximum of 24 weeks after birth. | Necrotizing enterocolitis |
| Secondary | Neonatal severe morbidity | From birth to discharge from hospital, with a maximum of 24 weeks after birth. | Retinopathy of prematurity |
| Secondary | Neonatal morbidity | At birth. | Severe fetal acidemia |
| Secondary | Neonatal morbidity | From birth to discharge from hospital, with a maximum of 24 weeks after birth. | Respiratory distress syndrome |
| Secondary | Neonatal morbidity | From birth to discharge from hospital, with a maximum of 24 weeks after birth. | Mild or moderate bronchopulmonary dysplasia |
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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