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Completed Phase 2Phase 3 Interventional Accepts healthy volunteers Results available

Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)

ClinicalTrials.gov ID: NCT01119963

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.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 9:19 AM EDT

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

Study identification

NCT ID
NCT01119963
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Obstetrix Medical Group
Industry
Enrollment
152 participants

Conditions and interventions

Interventions

  • 17-alpha-hydroxy-progesterone caproate, Makena® Drug
  • Castor Oil (Placebo) Drug

Drug

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 Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01119963 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →