Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Obstetrix Medical Group. The registered enrollment target is 152 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01119963
The ClinicalTrials.gov registry entry for NCT01119963 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Obstetrix Medical Group, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 17-alpha-hydroxy-progesterone caproate, Makena® is the first listed.
NCT01119963 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.