Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
NCT ID: NCT00086177
Last Updated: 2010-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
636 participants
INTERVENTIONAL
2004-04-30
2009-03-31
Brief Summary
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Detailed Description
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* A single baby pregnancy (no twins or triplets allowed)
* Patients will start treatment before pregnancy week 23
* Patients must have a previous preterm birth (a "preemie")
* Patients must be 18-45 years of age
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Progesterone 8% vaginal gel
8% progesterone vaginal gel
Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
2
Placebo Vaginal Gel
Placebo Vaginal Gel
Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
Interventions
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8% progesterone vaginal gel
Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
Placebo Vaginal Gel
Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
3. The pregnancy has an estimated gestational age between 16 0/7 weeks and 22 6/7 weeks.
4. The subject speaks either English or a common local language.
5. 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.
6. 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.
1. The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.
2. The subject has been treated with a progestogen within the previous 4 weeks.
3. 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).
4. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders.
5. The subject has liver dysfunction or disease.
6. The subject has known or suspected malignancy of the breast or genital organs.
7. The subject is currently participating in another investigational study or has participated in an investigational drug study within one month prior to screening for this study.
8. The subject's current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality.
9. The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus)
10. The subject has a multifetal gestation.
11. The subject has a cervical cerclage in place or has plans to have one placed during the current pregnancy.
12. The subject, in the judgment of the investigator, will be unable or unwilling to comply with study-related assessments and procedures.
13. 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.
14. The subject is HIV positive with a CD4 count of \_\<350 cells/mm3 and is receiving more than 1 medication to prevent the transfer of AIDS to the fetus.
15. The subject has placenta previa or a low-lying placenta. The subject will be considered for the study if she is not at risk for increased bleeding and has not been given any vaginal precautions.
16. The subject's qualifying preterm delivery was an indicated delivery without preterm labor (i.e. delivery performed for fetal distress, maternal eclampsia/preeclampsia, fetal death, or amnionitis in the absence of contractions).
18 Years
45 Years
FEMALE
Yes
Sponsors
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Juniper Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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VP Clinical Research, Columbia Laboratories
Principal Investigators
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George W Creasy, MD
Role: STUDY_DIRECTOR
VP Clinical Research; Columbia Laboratories, Inc
Locations
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University of South Alabama Department of OBGYN
Mobile, Alabama, United States
Visions Clinical Research-Tucson
Tucson, Arizona, United States
Women's Health Department
Colton, California, United States
SanDiego Perinatal Center
San Diego, California, United States
Harbor - UCLA Medical Center
Torrance, California, United States
Kaiser Permanente
Denver, Colorado, United States
Northside Maternal Fetal Specialists
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Maternal Fetal Medicine Norton Suburban Hospital
Louisville, Kentucky, United States
Maternal Fetal Medicine &Woman's Health Research
Baton Rouge, Louisiana, United States
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, United States
Johns Hopkins Community Physicians
Baltimore, Maryland, United States
Holy Cross Hospital
Silver Springs, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
St. Elizabeth's Medical Center -MFM
Brighton, Massachusetts, United States
St. Louis University
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
Department of OBGYN, St. Barnabas Medical Center
Livingston, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
St. Luke's - Roosevelt Hospital
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Pitt County Memorial Hospital
Greenville, North Carolina, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States
Ohio Permanente Medical Group
Bedford, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
MacDonald Clinical Trials Unit, University Hospitals of Cleveland
Cleveland, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Temple University Medical Center
Philadelphia, Pennsylvania, United States
Abington Primary Women's Healthcare
Willow Grove, Pennsylvania, United States
University Medical Group, Dept of OB/GYN
Greenville, South Carolina, United States
Regional Obstetrical Consultants
Chattanooga, Tennessee, United States
Gynecology & Obstetrics
Memphis, Tennessee, United States
Womens Partner In Health
Austin, Texas, United States
Health Central Women's Care
Dallas, Texas, United States
Clinical Research Center of Houston
Houston, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Texas Tech Health Sciences Center - Odessa
Odessa, Texas, United States
EVMS Maternal-Fetal Medicine, Hofheimer Hall
Norfolk, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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References
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da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003 Feb;188(2):419-24. doi: 10.1067/mob.2003.41.
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. doi: 10.1002/uog.5158.
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. doi: 10.1002/uog.5159.
O'Brien JM, Defranco EA, Adair CD, Lewis DF, Hall DR, How H, Bsharat M, Creasy GW; Progesterone Vaginal Gel Study Group. Effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2009 Dec;34(6):653-9. doi: 10.1002/uog.7338.
Other Identifiers
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COL-1620-300
Identifier Type: -
Identifier Source: org_study_id
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