Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
- Conditions
- Cervical RipeningLabor, Induced
- Interventions
- Registration Number
- NCT00308711
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief 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 cervical ripneing and induction of labor.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1308
- Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MVI 50 Misoprostol vaginal insert 50 mcg Misoprostol vaginal insert 50 mcg over 24h Cervidil 10 mg vaginal insert Dinoprostone vaginal insert (Cervidil) Cervidil 10 mg over 24h MVI 100 Misoprostol vaginal insert 100 mcg Misoprostol vaginal insert 100 mcg over 24h
- Primary Outcome Measures
Name Time Method Minutes From Drug Insertion to Vaginal Delivery 2880 minutes Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.
Percentage of Participants With a Cesarean Section Delivery 2880 minutes Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events 96 hours This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the "Maternal/Fetal" period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods.
Percentage of Participants With Pre-Delivery Oxytocin Use 2880 minutes Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor.
Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert 12 hours Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery.
Minutes to Onset of Active Labor 2880 minutes Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation.
Minutes to Rupture of Membranes (ROM) 2880 minutes Interval from study drug insertion to ROM.
Duration of Stay in Minutes in Labor and Delivery Suite 5760 minuts Minutes in Labor and Delivery (L \& D) suite starting from insertion of the study drug to discharge from L \& D to post partum care.
Days in Hospital for Mother and Neonate 10 days Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital.
Trial Locations
- Locations (52)
Trident Health System
🇺🇸North Charleston, South Carolina, United States
Methodist Charlton Medical Center
🇺🇸Dallas, Texas, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh - Magee Women's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Lehigh Valley Medical Center
🇺🇸Allentown, Pennsylvania, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
University of Tennesse Medical Center
🇺🇸Knoxville, Tennessee, United States
University of Cincinnati Holmes Hospital
🇺🇸Cincinnati, Ohio, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Texas Health Sciences Center at Houston
🇺🇸Houston, Texas, United States
St. Mark's Hospital
🇺🇸Salt Lake City, Utah, United States
University of Utah Health Science Center
🇺🇸Salt Lake City, Utah, United States
Arizona Wellness Center for Women
🇺🇸Phoenix, Arizona, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Alabama at Birmingham Medical Center
🇺🇸Birmingham, Alabama, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Banner Desert Medical Center
🇺🇸Mesa, Arizona, United States
Tuscon Medical Center
🇺🇸Tucson, Arizona, United States
UCI Medical Center
🇺🇸Orange, California, United States
Maricopa Medical Center
🇺🇸Phoenix, Arizona, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, 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
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Northside Hospital
🇺🇸Alpharetta, Georgia, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
University of New Mexico Medical Center
🇺🇸Albuquerque, New Mexico, United States
Women's Health Alliance
🇺🇸Winston-Salem, North Carolina, United States
St. Elizabeth Regional Medical Center
🇺🇸Lincoln, Nebraska, United States
Winthrop-South Nassau University Health Center
🇺🇸Mineola, New York, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
NYU School of Medicine
🇺🇸New York, New York, United States
United Health Services Hospitals, Inc.
🇺🇸Johnson City, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Legacy Center for Maternal-Fetal Medicine
🇺🇸Portland, Oregon, United States
Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Erlanger Hospital
🇺🇸Chattanooga, Tennessee, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
McKay-Dee Hospital
🇺🇸Ogden, Utah, United States
Jordan Valley Hospital
🇺🇸West Jordan, Utah, United States
Kings Daughters Clinic
🇺🇸Temple, Texas, United States
Pioneer Valley Hospital
🇺🇸West Valley City, Utah, United States
Overlake Hospital Medical Center
🇺🇸Bellevue, Washington, United States
Saint Clare's Hospital
🇺🇸Weston, Wisconsin, United States
Women's Health Centre/General Hospital/Eastern Health
🇨🇦St. John's, Newfoundland and Labrador, Canada
IWK Health Centre and Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
University of Saskatchewan Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada