Official Title: “Prochieve Extending Gestation A New Therapy for Short Cervix - Trial (PREGNANT Short Cervix - Trial)”

The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel in decreasing the preterm birth rate in a population of pregnant women with short cervical length and at high risk for preterm birth.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: progesterone
  • 8% vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation
• Drug: placebo
  • vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
  • placebo vaginal gel
• Active Comparator: Prochieve
  • Progesterone 8% Vaginal Gel

Primary Measures

• Reduction in the frequency of preterm birth (less than or equal to 32 0/7 weeks gestation).
  • Time Frame: Gestational age at delivery
    Safety Issue?: No

Secondary Measures

• Frequency of significant morbidity in infants during the initial hospitalization phase.
  • Time Frame: Delivery date to 28 days
    Safety Issue?: Yes

Inclusion Criteria:

• 1. The subject has a short cervical length by transvaginal ultrasound (TVU) defined as 10-20mm. In cases of "dynamic cervix", the shortest observed/documented cervical length by TVU is to be used as the cervical length for inclusion purposes.
• 2. Singleton gestation.
• 3. The pregnancy has an estimated gestational age between 19 0/7 weeks and 23 6/7 weeks.
• 4. The female subject is between 18 and 45 years of age at the time of screening.
• 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.

Exclusion Criteria:

• 1. The subject has a cervical length <10 or >20mm.
• 2. The subject has a multifetal gestation.
• 3. The subject has or will have a cervical cerclage in place at the time of randomization.
• 4. The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Columbia Laboratories

Overall Clinical Trial Officials and Contacts

George W. Creasy, MD, FACOG Study Director Columbia Laboratories, Inc.  

Overall Contact: Joseph R. Parella, RN 973-486-8855 jparella@columbialabs.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00615550

Study ID Number: COL-1620-302

ClinicalTrials.gov Identifier: NCT00615550

Health Authority: United States: Food and Drug Administration

A BRIEF REVIEW OF PROGESTINS IN PREGNANCY

Progesterone vaginal gel for the reduction of recurrent preterm birth (free download)

Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix (free download)

Progesterone and the Risk of Preterm Birth among Women with a Short Cervix (free download)

Prevention of sponatneous preterm birth: the role of sonographic cervical length in identifying patients who may benefit from progesterone treatment. (free download)