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NCT01119963 · ClinicalTrials.gov registry record · Phase 2
Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)
A Phase 2 study, sponsored by Obstetrix Medical Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
NCT01119963: Completed Phase 2 study, sponsored by Obstetrix Medical Group.
NCT01119963 is a Phase 2 study that has completed, run by Obstetrix Medical Group. The registered enrollment target is 152 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01119963, a Phase 2 study, has completed, sponsored by Obstetrix Medical Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
Study Summary
The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will: 1. increase the probability of continuing the pregnancy until a favorable gestational age. 2. increase the interval between randomization and delivery. 3. decrease neonatal morbidity.
Primary Outcome
Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born.
Interventions
- DRUG 17-alpha-hydroxy-progesterone caproate, Makena®
- DRUG Castor Oil (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT01119963 record still lists
NCT01119963 is an interventional study that assigns participants to a tested intervention. The registered 152 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 (14% higher).
The record links to 0 conditions, and to 2 interventions - of which 17-alpha-hydroxy-progesterone caproate, Makena® is the first listed.
NCT01119963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01119963 about?
NCT01119963 is a clinical study titled "Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)". The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will: 1. increase the probability of continuing the pregnancy until a favorable gestational age. 2. increase the interval between random...
What is the current status of trial NCT01119963?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2011-10. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01119963?
The interventions under investigation include: 17-alpha-hydroxy-progesterone caproate, Makena® (DRUG), Castor Oil (Placebo) (DRUG).
Who is sponsoring clinical trial NCT01119963?
This trial is sponsored by Obstetrix Medical Group, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01119963's enrollment target sits among peer trials
152 452nd of 2000 higher than 1,547 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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