The Effect of Vaginal Progesterone Administration in the prevention of Preterm Birth in Women with Short Cervix, [also Known as: Vaginal progesterone bioadhesive gel (Prochieve)® Extending Gestation A New Therapy for Short Cervix-Trial (PREGNANT Short Cervix-Trial)] - PREGNANT Short Cervix-Trial

Columbia Laboratories, Inc0 sites450 target enrollmentJuly 3, 2009

Overview

No summary available.

Registry

who.int

Start Date

July 3, 2009

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Columbia Laboratories, Inc

•1\. The subject has a short cervical lenght by transvaginal ultrasound (TCVU) defined as 10\-20 mm. In cases of dynamic cervix, the shortest observed/documented cervical lenght by TVU is to be used as the cervical lenght for inclusion purposis.
•2\. Singleton gestation.
•3\. The pregnancy has a estimated gestational age between 19 0/7 weeks and 23 6/7 weeks.
•4\. Maternal age between 15 (or local age of majority/emancipation) and 45 years od age at the time of screening. An alternative age range can be accepted according to the standards and applicable regulations of the study centers.
•5\. The subject speaks either English or a common local language.
•6\. The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding.
•7\. In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\. The subject has a cervical length \<10 or \>20 mm.
•2\. The subject has a multifetal gestation.
•3\. The subject has or is scheduled to have a cervical cerclage prior to randomization. According to ACOG Practice Bulletin Number 48 (November 2003\), cerclage can be considered in a subject with a history of 3 or more unexplained midtrimester pregnancy losses or preterm deliveries.228,229
•4\. Subjects diagnosed to have acute cervical insufficiency with bulging membranes passing the external os.
•5\. The subject has a previous of an adverse reaction to progesterone or any component present in Prochieve®/Crinone 8% vaginal gel.
•6\. The subject has been treated with a progestogen within the previous 4 weeks.
•7\. The subject is currently being treated for a seizure disorder, has an unstable psychiatric disorder, is taking antihypertensive therapy for chronic hypertension at the time of enrollment, has a history of congestive heart failure or chronic renal failure, or has uncontrolled diabetes mellitus (known end\-organ dysfunction secondary to vascular disease).
•8\. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone\-associated thrombophlebitis or a thromboembolic disorder.
•9\. The subject has active liver dysfunction or disease.
•10\. The subject has known or suspected malignancy of the breast or genital organs.