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NCT01050647 · ClinicalTrials.gov registry record · Phase 1
Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01050647: Completed Phase 1 study, sponsored by Stanford University.
NCT01050647 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01050647, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).
Primary Outcome
Delayed delivery until 34 weeks gestation.
Interventions
- DRUG 17-Hydroxyprogesterone Caproate
- OTHER Caster Oil injections
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-02 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01050647 record still lists
NCT01050647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which 17-Hydroxyprogesterone Caproate is the first listed.
NCT01050647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01050647 about?
NCT01050647 is a clinical study titled "Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.". Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to lear...
What is the current status of trial NCT01050647?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2010-02. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01050647?
The interventions under investigation include: 17-Hydroxyprogesterone Caproate (DRUG), Caster Oil injections (OTHER).
Who is sponsoring clinical trial NCT01050647?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01050647's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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