Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)
Public ClinicalTrials.gov record NCT01119963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
17-alpha-Hydroxyprogesterone Caproate (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM), Double-blinded Randomized Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01119963
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 152 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2011
- Primary completion
- Mar 31, 2014
- Completion
- Sep 30, 2014
- Last update posted
- Jun 27, 2018
2011 – 2014
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | — |
| Desert Good Samaritan Hospital | Mesa | Arizona | 85202 | — |
| Banner Good Samaritan Hospital | Phoenix | Arizona | 85006 | — |
| Tucson Medical Center | Tucson | Arizona | 85712 | — |
| Long Beach Memorial Medical Center | Long Beach | California | 90801-1428 | — |
| Good Samaritan Hospital | San Jose | California | 95124 | — |
| OConnor Hospital | San Jose | California | 95128 | — |
| Swedish Medical Center | Denver | Colorado | 80110 | — |
| Presbyterian/St Luke's Hospital | Denver | Colorado | 80218 | — |
| Norton Kosair Children's Hospital | Louisville | Kentucky | 40202 | — |
| Spectrum Health Hospital | Grand Rapids | Michigan | 49503 | — |
| Saint Luke's Hospital, Kansas City | Kansas City | Missouri | 64111 | — |
| Sunrise Medical Center | Las Vegas | Nevada | 89109 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267-0526 | — |
| Swedish Medical Center | Seattle | Washington | 98122-4307 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01119963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 27, 2018 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01119963 live on ClinicalTrials.gov.