Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
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|ClinicalTrials.gov Identifier: NCT01050647|
Recruitment Status : Active, not recruiting
First Posted : January 15, 2010
Results First Posted : April 17, 2018
Last Update Posted : May 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Complications||Drug: 17-Hydroxyprogesterone Caproate Other: Caster Oil injections||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||October 2018|
Active Comparator: 17-hydroxyprogesterone caproate
Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation
Drug: 17-Hydroxyprogesterone Caproate
Weekly injections of 17-hydroxyprogesterone caproate.
Other Name: Active study drug
Placebo Comparator: Castor oil injections
Weekly injections of Caster Oil (placebo)
Other: Caster Oil injections
Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
Other Name: Placebo
- Number of Participants With Achievement of 34 Weeks Gestation [ Time Frame: From enrollment until delivery, an average of 34 weeks ]Delayed delivery until 34 weeks gestation.
- Number of Participants With Neonatal Respiratory Distress Syndrome [ Time Frame: From delivery until neonatal hospital discharge, assessed up to 2 months ]
- Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage [ Time Frame: From delivery until neonatal hospital discharge, assessed up to 2 months ]
- Number of Participants With Neonatal Necrotizing Enterocolitis [ Time Frame: From delivery to neonatal discharge, assessed up to 2 months ]
- Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days [ Time Frame: From birth to discharge form delivery hospital, assessed up to 2 months ]
- Length of Latency Assessed as Number of Days [ Time Frame: From rupture of membranes until delivery, assessed up to 34 weeks of gestation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050647
|United States, California|
|Santa Clara Valley Medical Center|
|San Jose, California, United States, 95128|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Yasser Y El-Sayed, MD||Stanford University|