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NCT02133573 · ClinicalTrials.gov registry record · Phase 2
Randomized Trial of Maternal Progesterone Therapy
A Phase 2 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT02133573: Completed Phase 2 study, sponsored by Children's Hospital of Philadelphia.
NCT02133573 is a Phase 2 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02133573, a Phase 2 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a variety of clinical situations including brain injury can protect the brain. The purpose of this research study is to determine whether progesterone administered during the 3rd trimester of pregnancy (24-39 weeks) to pregnant women protects the brain of unborn babies with CHD and improves their neurodevelopmental outcomes after heart surgery.
Primary Outcome
The composite motor score is normed and has a mean of 100 (SD 15) and a range of 40-160. Scores between 71 and 85 indicate mild impairment and scores lower than 70 indicate moderate or severe impairment.
Interventions
- DRUG Progesterone
- DRUG Vaginal lubricant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2014-07 |
| Est. Completion | 2021-11 |
| Phase | Phase 2 |
What the finished NCT02133573 record still lists
NCT02133573 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Progesterone is the first listed.
NCT02133573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02133573 about?
NCT02133573 is a clinical study titled "Randomized Trial of Maternal Progesterone Therapy". Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a variety of clinical situations including brain injury can protect the brain....
What is the current status of trial NCT02133573?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2014-07. Estimated completion is 2021-11.
What interventions are being tested in trial NCT02133573?
The interventions under investigation include: Progesterone (DRUG), Vaginal lubricant (DRUG).
Who is sponsoring clinical trial NCT02133573?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02133573's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 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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