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NCT02469519 · ClinicalTrials.gov registry record · Phase 2
Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes
A Phase 2 study, sponsored by Pediatrix.
- Completed
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
NCT02469519: Completed Phase 2 study, sponsored by Pediatrix.
NCT02469519 is a Phase 2 study that has completed, run by Pediatrix. The registered enrollment target is 194 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02469519, a Phase 2 study, has completed, sponsored by Pediatrix.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
Study Summary
This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.
Primary Outcome
Composite Neonatal Morbidity includes any one or more of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or neonatal death.
Interventions
- DRUG Betamethasone - ACTIVE
- OTHER Normal Saline - PLACEBO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2016-03-03 |
| Est. Completion | 2022-10-31 |
| Phase | Phase 2 |
What the finished NCT02469519 record still lists
NCT02469519 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher).
The record links to 0 conditions, and to 2 interventions - of which Betamethasone - ACTIVE is the first listed.
NCT02469519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02469519 about?
NCT02469519 is a clinical study titled "Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes". This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.
What is the current status of trial NCT02469519?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2016-03-03. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT02469519?
The interventions under investigation include: Betamethasone - ACTIVE (DRUG), Normal Saline - PLACEBO (OTHER).
Who is sponsoring clinical trial NCT02469519?
This trial is sponsored by Pediatrix, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02469519's enrollment target sits among peer trials
194 352nd of 2000 higher than 1,649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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