Clinical trial NCT00308711: Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Ripening
Labor, Induced
Keywords: Cervical ripening
Induction of labor
Dinoprostone vaginal insert
Cervidil
Misoprostol vaginal insert
Modified Bishop's Score
PGE2
PGE1
Uterine Hyperstimulation
Cesarean section
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-03-30
Enrollment: 1308
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Minutes From Drug Insertion to Vaginal Delivery
timeFrame: 2880 minutes
measure: Percentage of Participants With a Cesarean Section Delivery
timeFrame: 2880 minutes
Secondary outcomes:
measure: Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events
timeFrame: 96 hours
measure: Percentage of Participants With Pre-Delivery Oxytocin Use
timeFrame: 2880 minutes
measure: Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert
timeFrame: 12 hours
measure: Minutes to Onset of Active Labor
timeFrame: 2880 minutes
measure: Minutes to Rupture of Membranes (ROM)
timeFrame: 2880 minutes
measure: Duration of Stay in Minutes in Labor and Delivery Suite
timeFrame: 5760 minuts
measure: Days in Hospital for Mother and Neonate
timeFrame: 10 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Medical Center
state: Alabama
city: Mesa
country: United States
facility: Banner Desert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Wellness Center for Women
state: Arizona
city: Tucson
country: United States
facility: Tuscon Medical Center
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: St. Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Tampa
country: United States
facility: University of Florida Health Sciences Center
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Medical Center
state: Florida
city: Alpharetta
country: United States
facility: Northside Hospital
state: Georgia
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Lincoln
country: United States
facility: St. Elizabeth Regional Medical Center
state: Nebraska
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Medical Center
state: New Mexico
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Johnson City
country: United States
facility: United Health Services Hospitals, Inc.
state: New York
city: Mineola
country: United States
facility: Winthrop-South Nassau University Health Center
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Women's Health Alliance
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Holmes Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Legacy Center for Maternal-Fetal Medicine
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Valley Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh - Magee Women's Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: North Charleston
country: United States
facility: Trident Health System
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Hospital
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennesse Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Dallas
country: United States
facility: Methodist Charlton Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Sciences Center at Houston
state: Texas
city: Temple
country: United States
facility: Kings Daughters Clinic
state: Texas
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Salt Lake City
country: United States
facility: St. Mark's Hospital
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Science Center
state: Utah
city: West Jordan
country: United States
facility: Jordan Valley Hospital
state: Utah
city: West Valley City
country: United States
facility: Pioneer Valley Hospital
state: Utah
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Weston
country: United States
facility: Saint Clare's Hospital
state: Wisconsin
city: St. John's
country: Canada
facility: Women's Health Centre/General Hospital/Eastern Health
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: IWK Health Centre and Dalhousie University
state: Nova Scotia
city: Saskatoon
country: Canada
facility: University of Saskatchewan Royal University Hospital
state: Saskatchewan
Study officials:
name: Helen Colquhoun, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.