Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
465 participants
INTERVENTIONAL
2008-03-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
placebo vaginal gel
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
Prochieve
Progesterone 8% Vaginal Gel
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
15 Years
45 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Juniper Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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George W. Creasy, MD, FACOG
Role: STUDY_DIRECTOR
Columbia Laboratories, Inc.
Roberto Romero, MD
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sonia Hassan, MD
Role: STUDY_DIRECTOR
Wayne State University
Locations
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University of South Alabama Dept. of OB/GYN
Mobile, Alabama, United States
St. Joseph's Hospital and Med Ctr Women's Care Center
Phoenix, Arizona, United States
UCI Medical Center
Orange, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
University of Miami Leonard Miller School of Medicine Department of Obstetrics and Gynecology
Miami, Florida, United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, United States
Perinatal Center of Iowa
Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Perinatal Diagnostic Center
Lexington, Kentucky, United States
Johns Hopkins Community Physicians
Baltimore, Maryland, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Perinatology Research Branch Hutzel Women's Hospital
Detroit, Michigan, United States
Henry Ford Healthcare System
Detroit, Michigan, United States
Spectrum Health Research Department
Grand Rapids, Michigan, United States
St. Joseph Mercy-Oakland
Pontiac, Michigan, United States
Washington University School of Medicine, Dept. of OB/GYN
St Louis, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
Winthrop University Hosital
Mineola, New York, United States
Albert Einstein Hospital
The Bronx, New York, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
UPHS Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital OB/GYN / Maternal Fetal Medicine
Philadelphia, Pennsylvania, United States
Regional Obstetrical Consultants, Chattanooga
Chattanooga, Tennessee, United States
Regional Obstetrical Consultants, Knoxville
Knoxville, Tennessee, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Charleston Area Medical Center Clinical Trials Center
Charleston, West Virginia, United States
1st Clinical Hospital of the City of Minsk
Minsk, , Belarus
Public Health Services Establishment "Vitebsk City Clinical Hospital of First Aid"
Vitebsk, , Belarus
Escuela De Medicina, Pontificia Universidad Catolica De Chile
Santiago, , Chile
Maternidad Hospital DR Sotero Del Rio
Santiago, , Chile
Charles University & General Teaching Hospital
Prague, , Czechia
BJ Medical College & Sassoon Hospital
Pune, Maharashtra, India
Sri Ramchandra Medical College and Research Institute
Porur, Tamil Nadu, India
Sheth L.G. Hospital
Ahmedabad, , India
MediCiti Institute of Medical Sciences
Andhra Pradesh, , India
Government Medical College
Nagpur, , India
Soroka University Medical Center
Beersheba, , Israel
Kaplan Medical Center
Rehovot, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Azienda Ospedaliera di Padova Centro Prenatale Divisione di Ostetricia
Padua, , Italy
Limited Liability Company "American Health Clinic"
Saint Petersburg, , Russia
Saint Petersburg State Healthcare Institution Maternity Hospital 17
Saint Petersburg, , Russia
Steve Biko Academic Hospital Dept. of OB-GYN and Maternal Fetal Medicine
Pretoria, , South Africa
Municipal health care establishment "City Maternity Clinical Hospital"
Chernivtsi, , Ukraine
Department of Obstetrics and Gynecology of Dnepropetrovsk State Medical Academy, Municipal establishment "City Maternity Hospital # 1"
Dnipro, , Ukraine
M. Gorky Donetsk National Medical University, Department of Obstetrics, Gynecology and Perinatology, Maternity Hospital of 6th Central City Clinical Hospital
Donetsk, , Ukraine
Municipal clinical hospital #1
Kiev, , Ukraine
Antenatal Clinic # 1, Central Polyclinics of Pechersk District
Kyiv, , Ukraine
Countries
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References
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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.
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. doi: 10.1056/NEJMoa067815.
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. doi: 10.1002/uog.5174. No abstract available.
Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.
Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003. Epub 2011 Dec 11.
Related Links
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Ultrasound Obstet Gynecol (2011)
Open Access to Final Study Result Publication
\[Individual Patient Data Meta-analysis\] Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data
Other Identifiers
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09-CH-N014
Identifier Type: -
Identifier Source: secondary_id
COL-1620-302
Identifier Type: -
Identifier Source: org_study_id
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