Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
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).
1 other identifier
interventional
1,308
2 countries
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2006
Shorter than P25 for phase_3
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 30, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedResults Posted
Study results publicly available
February 19, 2010
CompletedJune 25, 2012
June 1, 2012
1.3 years
March 27, 2006
July 29, 2009
June 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Minutes From Drug Insertion to Vaginal Delivery
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.
2880 minutes
Percentage of Participants With a Cesarean Section Delivery
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.
2880 minutes
Secondary Outcomes (7)
Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events
96 hours
Percentage of Participants With Pre-Delivery Oxytocin Use
2880 minutes
Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert
12 hours
Minutes to Onset of Active Labor
2880 minutes
Minutes to Rupture of Membranes (ROM)
2880 minutes
- +2 more secondary outcomes
Study Arms (3)
MVI 100
EXPERIMENTALMisoprostol vaginal insert 100 mcg over 24h
MVI 50
EXPERIMENTALMisoprostol vaginal insert 50 mcg over 24h
Cervidil 10 mg vaginal insert
ACTIVE COMPARATORCervidil 10 mg over 24h
Interventions
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.
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35249, United States
Banner Desert Medical Center
Mesa, Arizona, 85202, United States
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Arizona Wellness Center for Women
Phoenix, Arizona, 85032, United States
Tuscon Medical Center
Tucson, Arizona, 85716, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
UCI Medical Center
Orange, California, 92868, United States
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
Christiana Care Health System
Newark, Delaware, 19718, United States
Bayfront Medical Center
St. Petersburg, Florida, 33701, 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
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
United Health Services Hospitals, Inc.
Johnson City, New York, 13790, United States
Winthrop-South Nassau University Health Center
Mineola, New York, 11501, United States
NYU School of Medicine
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Women's Health Alliance
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati Holmes Hospital
Cincinnati, Ohio, 45267, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, 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
Lehigh Valley Medical Center
Allentown, Pennsylvania, 18103, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh - Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
Trident Health System
North Charleston, South Carolina, 29406, United States
Erlanger Hospital
Chattanooga, Tennessee, 37403, United States
University of Tennesse Medical Center
Knoxville, Tennessee, 37920, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38119, United States
Methodist Charlton Medical Center
Dallas, Texas, 75327, United States
University of Texas Health Sciences Center at Houston
Houston, Texas, 77030, United States
Kings Daughters Clinic
Temple, Texas, 76502, United States
McKay-Dee Hospital
Ogden, Utah, 84403, United States
St. Mark's Hospital
Salt Lake City, Utah, 84124, United States
University of Utah Health Science Center
Salt Lake City, Utah, 84132, United States
Jordan Valley Hospital
West Jordan, Utah, 84088, United States
Pioneer Valley Hospital
West Valley City, Utah, 84120, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
Saint Clare's Hospital
Weston, Wisconsin, 54476, United States
Women's Health Centre/General Hospital/Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
IWK Health Centre and Dalhousie University
Halifax, Nova Scotia, B3K 6R8, Canada
University of Saskatchewan Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Related Publications (7)
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.
PMID: 16157114BACKGROUNDRayburn 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.
PMID: 16443504BACKGROUNDEwert 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.
PMID: 17077234BACKGROUNDWing 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.
PMID: 18827122RESULTPevzner 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.
PMID: 19622986RESULTHawkins 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.
PMID: 28125096DERIVEDBrennan 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.
PMID: 21225563DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Barbara L. Powers
- Organization
- Cytokine PharmaSciences, Inc.
Study Officials
- STUDY DIRECTOR
Helen Colquhoun, MD
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2006
First Posted
March 30, 2006
Study Start
April 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
June 25, 2012
Results First Posted
February 19, 2010
Record last verified: 2012-06