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

Completed · Phase 3

Conditions studied: Cervical Ripening, Labor, Induced

In brief

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 cervical ripneing and induction of labor.

Key facts

Study ID

NCT00308711

Run by

Ferring Pharmaceuticals

People needed

1308

Starts

2006-04-01

Expected to finish

2007-08-01

Last updated by the study team

2012-06-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor

You may not qualify if…

• 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

Where it is running

• Banner Desert Medical Center — Mesa, Arizona, United States
• Maricopa Medical Center — Phoenix, Arizona, United States
• Arizona Wellness Center for Women — Phoenix, Arizona, United States
• Tuscon Medical Center — Tucson, Arizona, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• UCI Medical Center — Orange, California, United States
• Santa Clara Valley Medical Center — San Jose, California, United States
• Christiana Care Health System — Newark, Delaware, United States
• Bayfront Medical Center — St. Petersburg, Florida, United States
• University of Florida Health Sciences Center — Tampa, Florida, United States
• St. Mary's Medical Center — West Palm Beach, Florida, United States
• Northside Hospital — Alpharetta, Georgia, United States
• Hurley Medical Center — Flint, Michigan, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• St. Elizabeth Regional Medical Center — Lincoln, Nebraska, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• University of New Mexico Medical Center — Albuquerque, New Mexico, United States
• United Health Services Hospitals, Inc. — Johnson City, New York, United States
• Winthrop-South Nassau University Health Center — Mineola, New York, United States
• NYU School of Medicine — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States
• Women's Health Alliance — Winston-Salem, North Carolina, United States
• University of Cincinnati Holmes Hospital — Cincinnati, Ohio, United States
• University of Alabama at Birmingham Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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