Trial record 17 of 47 for:    necrotizing enterocolitis | NIH

PREGNANT Short Cervix Trial

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. Identifier: NCT00615550
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : March 13, 2012
Last Update Posted : March 13, 2012
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Juniper Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Preterm Delivery
Short Cervix
Short Uterine Cervical Length
Interventions: Drug: progesterone
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
March 2008 to June 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Placebo placebo vaginal gel
Prochieve Progesterone 8% Vaginal Gel

Participant Flow:   Overall Study
    Placebo   Prochieve
STARTED   229   236 
COMPLETED   223   235 
Lost to Follow-up                6                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Placebo placebo vaginal gel
Prochieve Progesterone 8% Vaginal Gel
Total Total of all reporting groups

Baseline Measures
   Placebo   Prochieve   Total 
Overall Participants Analyzed 
[Units: Participants]
 223   235   458 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   223   235   458 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 26.2  (5.1)   26.5  (5.8)   26.4  (5.5) 
[Units: Participants]
Female   223   235   458 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
Belarus   7   5   12 
United States   100   107   207 
Czech Republic   1   3   4 
Ukraine   26   28   54 
South Africa   11   10   21 
Russian Federation   0   1   1 
Israel   0   3   3 
Chile   2   0   2 
Italy   3   5   8 
India   73   73   146 

  Outcome Measures

1.  Primary:   Number of Participants With Birth <=32 6/7 Weeks Gestation.   [ Time Frame: 9 to 13 weeks ]

2.  Secondary:   Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)   [ Time Frame: Delivery Hospitalization (1-212 days) ]

3.  Secondary:   Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.   [ Time Frame: Gestational Age at Delivery ]

4.  Secondary:   Number of Neonates Who Died.   [ Time Frame: Delivery to 28 days ]

5.  Secondary:   Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams   [ Time Frame: date of delivery ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Trial not powered for subgroup analysis.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: George W Creasy MD
Organization: Columbia Laboratories
phone: 973-486-8797

Publications of Results:
Other Publications:

Responsible Party: Juniper Pharmaceuticals, Inc. Identifier: NCT00615550     History of Changes
Other Study ID Numbers: COL-1620-302
First Submitted: January 18, 2008
First Posted: February 14, 2008
Results First Submitted: February 24, 2012
Results First Posted: March 13, 2012
Last Update Posted: March 13, 2012