PREGNANT Short Cervix Trial

Condition(s) targeted: Preterm Delivery; Short Cervix; Short Uterine Cervical Length

Intervention: progesterone (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Columbia Laboratories

Official(s) and/or principal investigator(s):
George W. Creasy, MD, FACOG, Study Director, Affiliation: Columbia Laboratories, Inc.
Roberto Romero, MD, Study Director, Affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sonia Hassan, MD, Study Director, Affiliation: Wayne State University

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

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.

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

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

Primary outcome: Reduction in the frequency of preterm birth (less than or equal to 32 6/7 weeks gestation).

Secondary outcome:

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)

Reduction in the frequency of preterm birth at ≤27 6/7, ≤34 6/7, and <36 6/7 weeks gestation

Reduction in the frequency of neonatal mortality

Reduction in the frequency of admission for preterm labor

Assessment of the admission-to-delivery interval in subjects receiving tocolytic therapy for preterm labor

Assessment of Apgar scores, length, weight, and head circumference at birth, and incidence of congenital anomalies

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

Minimum age: 15 Years. Maximum age: 45 Years. Gender(s): Female.

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.

Joseph R. Parella, RN, Phone: 973-486-8855, Email: jparella@columbialabs.com

MediCiti Institute of Medical Sciences, Andhra Pradesh 5014, India; Recruiting
Dr. Rehka, Phone: 8418-256201
Dr. D. Vidyadhari, Principal Investigator

Government Medical College, Nagpur 440003, India; Recruiting
Dr. Alka Patankar, Phone: +91-712-2705981
Dr. Shalini Fusey, Principal Investigator

Sheth L.G. Hospital, Ahmedabad 380008, India; Recruiting
Dr. Megha Patel, Phone: 079-25854222
Dr. Yamini Trivedi, Principal Investigator

Soroka University Medical Center, Beer-Sheva 84965, Israel; Recruiting
Ruth Cohen, Phone: 972-50-9170796, Email: rut1702@walla.com
Asher Bashiri, MD, Principal Investigator

Azienda Ospedaliera di Padova Centro Prenatale Divisione di Ostetricia, Padova 35128, Italy; Recruiting
Leda Borghero, Phone: 011-39-0498211605, Email: leda.borghero@gmail.com
Maria T. Gervasi, MD, Principal Investigator

Steve Biko Academic Hospital Dept. of OB-GYN and Maternal Fetal Medicine, Pretoria 0001, South Africa; Recruiting
Priya Soma-Pillay, MD, Phone: (012) 354 2830/2849, Email: Priya.Soma-Pillay@up.ac.za
Priya Soma-Pillay, MD, Principal Investigator

University of South Alabama Dept. of OB/GYN, Mobile, Alabama 36604, United States; Active, not recruiting

St. Joseph's Hospital and Med Ctr Women's Care Center, Phoenix, Arizona 85013, United States; Recruiting
Kelli Williamson, RN, MPH, Phone: 602-406-6689, Email: Kelli.Williamson@chw.edu
James Balducci, MD, MBA, Principal Investigator

Harbor-UCLA Medical Center, Torrance, California 90502, United States; Recruiting
Margaret Portamo, Phone: 310-222-3544
Marie H Beall, MD, Principal Investigator

UCI Medical Center, Orange, California 92868, United States; Recruiting
Pam Rumney, RNC, Phone: 714-456-2217, Email: prumney@uci.edu
Deborah A. Wing, MD, Principal Investigator

Kapi'olani Medical Center for Women and Children, Honolulu, Hawaii 96826, United States; Recruiting
Felix Militante, RN, Phone: 808-983-8749, Email: felix.militante@kapiolani.org
Ivica Zalud, MD, Principal Investigator

Perinatal Center of Iowa, Des Moines, Iowa 50314, United States; Recruiting
Catherine Wallace, Phone: 515-643-6888, Email: cwallace@mercydesmoines.org
Joseph Hwang, MD, Principal Investigator

University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Margee Clark, MS, ARNP, RNC, Phone: 913-588-6287, Email: mclark4@kumc.edu
Carl P. Weiner, MD, MBA, Principal Investigator

Perinatal Diagnostic Center, Lexington, Kentucky 40503, United States; Recruiting
Karen Willis, Phone: 859-260-6066, Email: Kwillis@BHSI.com
John M. O'Brien, MD, Principal Investigator

BJ Medical College & Sassoon Hospital, Pune, Maharashtra 411001, India; Recruiting
Dr. Pradip Sambarey, Phone: +91 20 9822294870, Email: drsambarey@yahoo.co.in
Dr. Pradip Sambarey, Principal Investigator

Perinatology Research Branch Hutzel Women's Hospital, Detroit, Michigan 48201, United States; Recruiting
Janine Bieda, Phone: 313-577-5774, Email: jbied@med.wayne.edu
Sonia Hassan, MD, Principal Investigator

Spectrum Health Research Department, Grand Rapids, Michigan 49503, United States; Recruiting
Marcy Ross, Phone: 616-486-6129, Email: Marcy.Ross@spectrum-health.org
Asad Sheikh, MD, Principal Investigator

Henry Ford Healthcare System, Detroit, Michigan 48202, United States; Recruiting
Katie Miracola, Phone: 313-916-3535, Email: kmiraco1@hfhs.org
Marc Lewis, MD, Principal Investigator

Washington University School of Medicine, Dept. of OB/GYN, St. Louis, Missouri 63110, United States; Recruiting
Linda Odibo, Phone: 314-362-7834, Email: odibol@wudosis.wustl.edu
Anthony Odibo, MD, MSCE, Principal Investigator

St. Louis University Health Sciences Center, St. Louis, Missouri 63117, United States; Recruiting
Suzanne Hampton, BSN, RN, Phone: 314-977-7455, Email: shampt10@slu.edu
Raul Artal, MD, Principal Investigator

Cooper University Hospital, Camden, New Jersey 08103, United States; Recruiting
Clare Hansen, Phone: 856-968-7547, Email: Hansen-Clare@CooperHealth.edu
Meena Khandelwal, MD, Principal Investigator

Albert Einstein Hospital, Bronx, New York 10461, United States; Recruiting
Sunita Kasliwal, MD, Phone: 718-904-3054, Email: skasliwa@montefiore.org
Ashlesha K. Dayal, MD, Principal Investigator

Winthrop University Hosital, Mineola, New York 11501, United States; Recruiting
Evelyn Schwartz, Phone: 516-663-9582, Email: eschwartz@winthrop.org
Wendy Kinzler, MD, Principal Investigator

Lyndhurst Clinical Research, Winston-Salem, North Carolina 27103, United States; Recruiting
Lisa Cumming, Phone: 336-397-3707, Email: lcumming@lyndhurstgyn.com
Robert L. Parker, MD, FACOG, Principal Investigator

Thomas Jefferson University Hospital OB/GYN / Maternal Fetal Medicine, Philadelphia, Pennsylvania 19107, United States; Recruiting
Susan M. Weiner, PhD(c), MSN, RNC, Phone: 215-955-9200, Email: susan.weiner@jefferson.edu
Jason K. Baxter, MD, MSCP, Principal Investigator

UPHS Pennsylvania Hospital, Philadelphia, Pennsylvania 19107-6130, United States; Recruiting
Irma Yehuda, CRNP, Phone: 215-829-2345
Harish M. Sehdev, MD, FACOG, Principal Investigator

Sri Ramchandra Medical College and Research Institute, Porur, Tamil Nadu 600003, India; Recruiting
Dr. Java Vijayaraghavan, Phone: +91 44 24768403, Ext: 8606, Email: aparnaraghavan@yahoo.com
Dr. Java Vijayarahavan, Principal Investigator

Regional Obstetrical Consultants, Knoxville, Knoxville, Tennessee 37920, United States; Active, not recruiting

Regional Obstetrical Consultants, Chattanooga, Chattanooga, Tennessee 37403, United States; Active, not recruiting

University of Texas Health Sciences Center, San Antonio, Texas 78229, United States; Recruiting
Margaret F. Carter, MD, Phone: 210-567-7500, Email: cartermf@uthscsa.edu
Elly Xenakis, MD, Principal Investigator

Eastern Virginia Medical School, Norfolk, Virginia 23507, United States; Recruiting
Elizabeth Strode, Phone: 757-446-7087, Email: strodeel@evms.edu
Bonnie J. Dattel, MD, Principal Investigator

Charleston Area Medical Center Clinical Trials Center, Charleston, West Virginia 25304, United States; Recruiting
Krystal R. McConihay, BS, Phone: 304-388-9984, Email: krystal.mcconihay@camc.org
Luis A. Bracero, MD, Principal Investigator

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)

Related publications:

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.

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.

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.

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.

Starting date: March 2008
Ending date: March 2010
Last updated: July 16, 2009