The Use of Progesterone to Reduce Preterm Birth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00830765|
Recruitment Status : Completed
First Posted : January 28, 2009
Results First Posted : February 20, 2013
Last Update Posted : February 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth||Drug: Progesterone (OHP17) Drug: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Use of Progesterone to Reduce Preterm Birth|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||June 2010|
Placebo Comparator: 1 Placebo
The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
2cc of placebo liquid formulated by pharmacy personnel at the University of Mississippi Medical Center injected IM weekly until 34 weeks' gestation has been reached or delivery, whichever occurs first.
Active Comparator: Progesterone
The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
Drug: Progesterone (OHP17)
100mg of OHP17 or comparable amount of placebo administered by IM injection weekly until either 34 weeks' gestation or delivery has been achieved, whichever occurs first.
- Weeks Gestation at Birth Among Patients Receiving the Active Drug. [ Time Frame: Through delivery, until discharge up to 40 weeks gestation ]Weeks gestation at birth, the interval to delivery, or neonatal morbitity.
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): NCT00830765
|United States, Mississippi|
|Winfred L Wiser Hospital for Women and Infants at the University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||John C Morrison, MD||University of Mississippi Medical Center|