Expired Study
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Mobile, Alabama 36604


Purpose:

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.


Criteria:

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. Maternal age between 15 (or local age of majority/emancipation) and 45 years of 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. Exclusion Criteria: 1. The subject has a cervical length <10 or >20mm. 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 history of an adverse reaction to progesterone or any component present in Prochieve® 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 thromboembolic disorders. 9. The subject has active liver dysfunction or disease. 10. The subject has known or suspected malignancy of the breast or genital organs. 11. The subject is currently participating in another interventional study or has participated in an interventional drug study within one month prior to screening for this study. 12. The subject's current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality. 13. The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus) 14. The subject, in the judgment of the investigator, will be unable or unwilling to comply with study-related assessments and procedures. 15. The subject currently has preterm rupture of membranes, vaginal bleeding, known or suspected amnionitis, or signs or symptoms of preterm labor at the time of enrollment. 16. The subject is HIV positive with a CD4 count of <350 cells/mm3 and is receiving more than one (1) medication to prevent the transfer of AIDS to the fetus. 17. Complete placenta previa.


Study is Available At:


Original ID:

COL-1620-302


NCT ID:

NCT00615550


Secondary ID:

09-CH-N014


Study Acronym:


Brief Title:

PREGNANT Short Cervix Trial


Official Title:

The Effect of Vaginal Progesterone Administration in the Prevention of Preterm Birth in Women With a Short Cervix [Vaginal Progesterone Bioadhesive Gel (Prochieve)® Extending Gestation A New Therapy for Short Cervix - Trial (PREGNANT Short Cervix - Trial)


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

15 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Columbia Laboratories


Oversight Authority:

  • United States: Food and Drug Administration
  • India: Drugs Controller General of India
  • Israel: Ministry of Health
  • Italy: Ethics Committee
  • Chile: Instituto de Salud Pública de Chile
  • Russia: Pharmacological Committee, Ministry of Health
  • Ukraine: Ministry of Health
  • Belarus: Ministry of Health
  • South Africa: Medicines Control Council
  • Czech Republic: State Institute for Drug Control


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

450


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:March 2008
Completion Date:November 2010
Completion Type:Actual
Primary Completion Date:November 2010
Primary Completion Type:Actual
Verification Date:June 2011
Last Changed Date:June 24, 2011
First Received Date:January 18, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Reduction in the frequency of preterm birth (less than or equal to 32 6/7 weeks gestation).
Time Frame:Gestational age at delivery
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Reduction in the frequency of neonatal morbidities such as respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), proven sepsis, and necrotizing enterocolitis (NEC)
Time Frame:Delivery date to 28 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Reduction in the frequency of preterm birth at ≤27 6/7, ≤34 6/7, and <36 6/7 weeks gestation
Time Frame:Gestational Age at Delivery
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Reduction in the frequency of neonatal mortality
Time Frame:Delivery date to 28 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Assessment of other indicators of neonatal morbidity such as admission to the NICU, the duration of stay in the NICU, and the total hospital stay
Time Frame:date of delivery to 28 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Assessment of Apgar scores, length, weight, and head circumference at birth, and incidence of congenital anomalies
Time Frame:date of delivery
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Assessment of the admission-to-delivery interval in subjects receiving tocolytic therapy for preterm labor
Time Frame:20 0/7 weeks to 32 6/7 weeks gestation
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Reduction in the frequency of admission for preterm labor
Time Frame:20 0/7 weeks to 32 6/7 weeks gestation
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:progesterone
Description: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
Arm Name:Prochieve
Other Name:Prochieve 8%
Intervention Type:Drug
Name:placebo
Description:vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:placebo vaginal gel
Study Arm Type:Active Comparator
Arm Name:Prochieve
Description:Progesterone 8% Vaginal Gel

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Columbia Laboratories
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:O'Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, Soma-Pillay P, Porter K, How H, Schackis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):687-96.
PMID:17899572
Reference Type:Reference
Citation:DeFranco EA, O'Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S, Soma-Pillay P, Porter K, How H, Schakis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):697-705.
PMID:17899571
Reference Type:Reference
Citation:Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9.
PMID:17671254
Reference Type:Reference
Citation:Romero R. Prevention of spontaneous preterm birth: the role of sonographic cervical length in identifying patients who may benefit from progesterone treatment. Ultrasound Obstet Gynecol. 2007 Oct;30(5):675-86. No abstract available.
PMID:17899585

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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