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Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor

Information source: Cytokine PharmaSciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cervical Ripening; Labor, Induced

Intervention: Misoprostol vaginal insert 100 mcg (Drug); Misoprostol vaginal insert 50 mcg (Drug); Dinoprostone vaginal insert (Cervidil) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cytokine PharmaSciences

Official(s) and/or principal investigator(s):
Helen Colquhoun, MD, Study Director, Affiliation: Unaffiliated

Summary

The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have their labor induced.

Clinical Details

Official title: A Multi-Center, Randomized, Double-Blind Phase III Study of the Efficacy and Safety of the Misoprostol Vaginal Insert Compared to Cervidil for Women Requiring Cervical Ripening and Induction of Labor (The MVP Study).

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Time to vaginal delivery

Rate of Cesarean Section delivery

Secondary outcome:

Incidence of adverse events ( and comparison of overall safety

Need for oxytocin, duration of oxytocin use, total dose of oxytocin

Successful cervical ripening using Modified Bishop's Score at 12 hours

Time to onset of active labor

Time to rupture of membranes

Duration of stay in labor and delivery suite

Duration of stay in hospital for mother and neonate

Detailed description: Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the womb (uterus), before oxytocin can be started. Prostaglandins have been shown to ripen, or soften, the cervix; at present, the only prostaglandin approved for marketing by FDA for this purpose is dinoprostone. Dinoprostone can be delivered in several ways; one method is to use a polymer vaginal insert that slowly releases the dinoprostone directly to the cervical tissues. This product is called Cervidil (R) and has been marketed for more than 10 years in the United States. Misoprostol is another form of prostaglandin that is approved for protecting the stomach and intestinal lining for patients taking NSAIDs. Misoprostol has also been used by many obstetricians for cervical ripening and inducing contractions, but, it is not approved by FDA for this purpose.

The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol. This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil. Two different doses of misoprostol will be tested (50 micrograms and 100 micrograms); each vaginal insert will gradually release a small, controlled amount of misoprostol over up to 24 hours.

Comparator: The Cervidil (R) vaginal insert containing dinoprostone will be the comparator in this study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Pregnant women at least 36 weeks gestation requiring cervical ripening and induction

of labor

Exclusion Criteria:

- No uterine scar (no previous delivery by cesarean section)

- No multiple gestation

- No condition that disallows use of prostaglandins for induction of labor

- No more than 3 previous vaginal births beyond 24 weeks gestation

Locations and Contacts

University of Alabama at Birmingham Medical Center, Birmingham, Alabama 35249, United States

Maricopa Medical Center, Phoenix, Arizona 85008, United States

Banner Desert Medical Center, Mesa, Arizona 85202, United States

Arizona Wellness Center for Women, Phoenix, Arizona 85032, United States

Tuscon Medical Center, Tucson, Arizona 85716, United States

UCI Medical Center, Orange, California 92868, United States

Santa Clara Valley Medical Center, San Jose, California 95128, United States

Long Beach Memorial Medical Center, Long Beach, California 90806, United States

Christiana Care Health System, Newark, Delaware 19718, United States

University of Florida Health Sciences Center, Tampa, Florida 33606, United States

St. Mary's Medical Center, West Palm Beach, Florida 33401, United States

Bayfront Medical Center, St. Petersburg, Florida 33701, United States

Northside Hospital, Alpharetta, Georgia 30005, United States

Hurley Medical Center, Flint, Michigan 48503, United States

University of Minnesota Medical Center, Minneapolis, Minnesota 55455, United States

St. Elizabeth Regional Medical Center, Lincoln, Nebraska 68510, United States

Morristown Memorial Hospital, Morristown, New Jersey 07962, United States

University of New Mexico Medical Center, Albuquerque, New Mexico 87131, United States

Columbia University Medical Center, New York, New York 10032, United States

Winthrop-South Nassau University Health Center, Mineola, New York 11501, United States

United Health Services Hospitals, Inc., Johnson City, New York 13790, United States

NYU School of Medicine, New York, New York 10016, United States

Jacobi Medical Center, Bronx, New York 10461, United States

Women's Health Centre/General Hospital/Eastern Health, St. John's, Newfoundland and Labrador A1B 3V6, Canada

Women's Health Alliance, Winston-Salem, North Carolina 27103, United States

IWK Health Centre and Dalhousie University, Halifax, Nova Scotia B3K 6R8, Canada

Ohio State University Medical Center, Columbus, Ohio 43210, United States

University of Cincinnati Holmes Hospital, Cincinnati, Ohio 45267, United States

Miami Valley Hospital, Dayton, Ohio 45409, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Legacy Center for Maternal-Fetal Medicine, Portland, Oregon 97232, United States

Abington Memorial Hospital, Abington, Pennsylvania 19090, United States

Lankenau Hospital, Wynnewood, Pennsylvania 19096, United States

University of Pittsburgh - Magee Women's Hospital, Pittsburgh, Pennsylvania 15213, United States

Lehigh Valley Medical Center, Allentown, Pennsylvania 18103, United States

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States

University of Saskatchewan Royal University Hospital, Saskatoon, Saskatchewan S7N 0W8, Canada

Greenville Hospital System, Greenville, South Carolina 29605, United States

Trident Health System, North Charleston, South Carolina 29406, United States

Baptist Memorial Hospital, Memphis, Tennessee 38119, United States

Erlanger Hospital, Chattanooga, Tennessee 37403, United States

University of Tennesse Medical Center, Knoxville, Tennessee 37920, United States

University of Texas Health Sciences Center at Houston, Houston, Texas 77030, United States

Kings Daughters Clinic, Temple, Texas 76502, United States

Methodist Charlton Medical Center, Dallas, Texas 75327, United States

University of Utah Health Science Center, Salt Lake City, Utah 84132, United States

Pioneer Valley Hospital, West Valley City, Utah 84120, United States

Jordan Valley Hospital, West Jordan, Utah 84088, United States

McKay-Dee Hospital, Ogden, Utah 84403, United States

St. Mark's Hospital, Salt Lake City, Utah 84124, United States

Overlake Hospital Medical Center, Bellevue, Washington 98004, United States

Saint Clare's Hospital, Weston, Wisconsin 54476, United States

Additional Information

Related publications:

Castaneda CS, Izquierdo Puente JC, Leon Ochoa RA, Plasse TF, Powers BL, Rayburn WF. Misoprostol dose selection in a controlled-release vaginal insert for induction of labor in nulliparous women. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 2):1071-5.

Rayburn WF, Powers BL, Plasse TF, Carr D, Di Spirito M. Pharmacokinetics of a controlled-release misoprostol vaginal insert at term. J Soc Gynecol Investig. 2006 Feb;13(2):112-7.

Ewert K, Powers B, Robertson S, Alfirevic Z. Controlled-release misoprostol vaginal insert in parous women for labor induction: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1130-7.

Starting date: April 2006
Ending date: August 2007
Last updated: September 10, 2007

Page last updated: June 20, 2008

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