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

Sponsor:	Cytokine PharmaSciences
Information provided by:	Cytokine PharmaSciences
ClinicalTrials.gov Identifier:	NCT00308711

Purpose

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.

Condition	Intervention	Phase
Cervical Ripening Labor, Induced	Drug: Misoprostol vaginal insert 100 mcg Drug: Misoprostol vaginal insert 50 mcg Drug: Dinoprostone vaginal insert (Cervidil)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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).

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Misoprostol Dinoprostone

U.S. FDA Resources

Further study details as provided by Cytokine PharmaSciences:

Primary Outcome Measures:

Time to vaginal delivery [ Time Frame: Following administration of study medication ]
Rate of Cesarean Section delivery [ Time Frame: Following administration of study medication ]

Secondary Outcome Measures:

Incidence of adverse events ( and comparison of overall safety [ Time Frame: Following administration of study medication ]
Need for oxytocin, duration of oxytocin use, total dose of oxytocin [ Time Frame: Pre-delivery ]
Successful cervical ripening using Modified Bishop's Score at 12 hours [ Time Frame: At 12 hours after study drug insertion ]
Time to onset of active labor [ Time Frame: From study drug insertion to onset active labor ]
Time to rupture of membranes [ Time Frame: Interval from study drug insertion to ROM ]
Duration of stay in labor and delivery suite [ Time Frame: While in the study ]
Duration of stay in hospital for mother and neonate [ Time Frame: While in the study ]

Enrollment:	1300
Study Start Date:	April 2006
Study Completion Date:	August 2007

Arms	Assigned Interventions
MVI 100: Experimental Misoprostol vaginal insert 100 mcg over 24h	Drug: Misoprostol vaginal insert 100 mcg
MVI 50: Experimental Misoprostol vaginal insert 50 mcg over 24h	Drug: Misoprostol vaginal insert 50 mcg
Cervidil 10 mg vaginal insert: Active Comparator Cervidil 10 mg over 24h	Drug: Dinoprostone vaginal insert (Cervidil)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308711

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Locations

United States, Alabama
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States, 35249
United States, Arizona
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
Banner Desert Medical Center
Mesa, Arizona, United States, 85202
Arizona Wellness Center for Women
Phoenix, Arizona, United States, 85032
Tuscon Medical Center
Tucson, Arizona, United States, 85716
United States, California
UCI Medical Center
Orange, California, United States, 92868
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19718
United States, Florida
University of Florida Health Sciences Center
Tampa, Florida, United States, 33606
St. Mary's Medical Center
West Palm Beach, Florida, United States, 33401
Bayfront Medical Center
St. Petersburg, Florida, United States, 33701
United States, Georgia
Northside Hospital
Alpharetta, Georgia, United States, 30005
United States, Michigan
Hurley Medical Center
Flint, Michigan, United States, 48503
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
United States, New Mexico
University of New Mexico Medical Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Winthrop-South Nassau University Health Center
Mineola, New York, United States, 11501
United Health Services Hospitals, Inc.
Johnson City, New York, United States, 13790
NYU School of Medicine
New York, New York, United States, 10016
Jacobi Medical Center
Bronx, New York, United States, 10461
United States, North Carolina
Women's Health Alliance
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
University of Cincinnati Holmes Hospital
Cincinnati, Ohio, United States, 45267
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Center for Maternal-Fetal Medicine
Portland, Oregon, United States, 97232
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19090
Lehigh Valley Medical Center
Allentown, Pennsylvania, United States, 18103
University of Pittsburgh - Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Trident Health System
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38119
Erlanger Hospital
Chattanooga, Tennessee, United States, 37403
University of Tennesse Medical Center
Knoxville, Tennessee, United States, 37920
United States, Texas
University of Texas Health Sciences Center at Houston
Houston, Texas, United States, 77030
Kings Daughters Clinic
Temple, Texas, United States, 76502
Methodist Charlton Medical Center
Dallas, Texas, United States, 75327
United States, Utah
University of Utah Health Science Center
Salt Lake City, Utah, United States, 84132
McKay-Dee Hospital
Ogden, Utah, United States, 84403
Jordan Valley Hospital
West Jordan, Utah, United States, 84088
Pioneer Valley Hospital
West Valley City, Utah, United States, 84120
St. Mark's Hospital
Salt Lake City, Utah, United States, 84124
United States, Washington
Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
United States, Wisconsin
Saint Clare's Hospital
Weston, Wisconsin, United States, 54476
Canada, Newfoundland and Labrador
Women's Health Centre/General Hospital/Eastern Health
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre and Dalhousie University
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Saskatchewan
University of Saskatchewan Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8

Sponsors and Collaborators

Cytokine PharmaSciences

Investigators

Study Director:

Helen Colquhoun, MD

Unaffiliated

More Information

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	Miso-Obs-004
Study First Received:	March 27, 2006
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00308711 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cytokine PharmaSciences:

Cervical ripening
Induction of labor
Dinoprostone vaginal insert
Cervidil
Misoprostol vaginal insert

Modified Bishop's Score
PGE2
PGE1
Uterine Hyperstimulation
Cesarean section

Additional relevant MeSH terms:

Dinoprostone
Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Abortifacient Agents
Physiological Effects of Drugs

Misoprostol
Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009