Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
NCT ID: NCT00308711
Last Updated: 2012-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1308 participants
INTERVENTIONAL
2006-04-30
2007-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MVI 100
Misoprostol vaginal insert 100 mcg over 24h
Misoprostol vaginal insert 100 mcg
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
MVI 50
Misoprostol vaginal insert 50 mcg over 24h
Misoprostol vaginal insert 50 mcg
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Cervidil 10 mg vaginal insert
Cervidil 10 mg over 24h
Dinoprostone vaginal insert (Cervidil)
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Interventions
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Misoprostol vaginal insert 100 mcg
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Misoprostol vaginal insert 50 mcg
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Dinoprostone vaginal insert (Cervidil)
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Helen Colquhoun, MD
Role: STUDY_DIRECTOR
Locations
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University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States
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
Ohio State University Medical Center
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Legacy Center for Maternal-Fetal Medicine
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lehigh Valley Medical Center
Allentown, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh - Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, United States
Trident Health System
North Charleston, South Carolina, United States
Erlanger Hospital
Chattanooga, Tennessee, United States
University of Tennesse Medical Center
Knoxville, Tennessee, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Methodist Charlton Medical Center
Dallas, Texas, United States
University of Texas Health Sciences Center at Houston
Houston, Texas, United States
Kings Daughters Clinic
Temple, Texas, United States
McKay-Dee Hospital
Ogden, Utah, United States
St. Mark's Hospital
Salt Lake City, Utah, United States
University of Utah Health Science Center
Salt Lake City, Utah, United States
Jordan Valley Hospital
West Jordan, Utah, 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
Countries
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References
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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. doi: 10.1016/j.ajog.2005.06.072.
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. doi: 10.1016/j.jsgi.2005.10.004.
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. doi: 10.1097/01.AOG.0000239100.16166.5a.
Wing DA; Misoprostol Vaginal Insert Consortium. Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):801-12. doi: 10.1097/AOG.0b013e318187042e.
Pevzner L, Rayburn WF, Rumney P, Wing DA. Factors predicting successful labor induction with dinoprostone and misoprostol vaginal inserts. Obstet Gynecol. 2009 Aug;114(2 Pt 1):261-267. doi: 10.1097/AOG.0b013e3181ad9377.
Hawkins JS, Stephenson M, Powers B, Wing DA. Diabetes mellitus: an independent predictor of duration of prostaglandin labor induction. J Perinatol. 2017 May;37(5):488-491. doi: 10.1038/jp.2016.270. Epub 2017 Jan 26.
Brennan MC, Pevzner L, Wing DA, Powers BL, Rayburn WF. Retention of dinoprostone vaginal insert beyond 12 hours for induction of labor. Am J Perinatol. 2011 Jun;28(6):479-84. doi: 10.1055/s-0030-1271208. Epub 2011 Jan 11.
Other Identifiers
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Miso-Obs-004
Identifier Type: -
Identifier Source: org_study_id
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