Clinical trial NCT01127581: Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
Official title: Phase III, Double-blind, Randomized, Multicenter Study of Exogenous Prostaglandin Comparing the Efficacy & Safety of the MVI 200 mcg Versus the Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery in Pregnant Women at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Reducing Time to Vaginal Delivery
Cervical Ripening
Induction of Labor
Keywords: Misoprostol vaginal insert
Dinoprostone vaginal insert
Cervidil
Cervical ripening
Induction of labor
Rate of cesarean section
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 1358
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 (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent;
* Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
* Women aged 18 years or older;
* Candidate for pharmacological induction of labor;
* Single, live vertex fetus;
* Baseline modified Bishop score ≤ 4;
* Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
* Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion Criteria:

* Women in active labor;
* Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
* Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
* Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
* Fetal malpresentation;
* Diagnosed congenital anomalies, not including polydactyly;
* Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
* Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
* Ruptured membranes ≥ 48 hours prior to the start of treatment;
* Suspected chorioamnionitis;
* Fever (oral or aural temperature \> 37.5°C);
* Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
* Known or suspected allergy to misoprostol, dinoprostone, other prostaglandins or any of the excipients;
* Any condition urgently requiring delivery;
* Unable to comply with the protocol.

Primary outcomes:
measure: Time to Vaginal Delivery During the First Hospital Admission
timeFrame: Interval from study drug administration to vaginal delivery (average 24 hours)
measure: Incidence of Cesarean Delivery During the First Hospital Admission
timeFrame: Interval from study drug administration to cesarean delivery (average 24 hours)
Secondary outcomes:
measure: Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission
timeFrame: Interval from study drug administration to neonate delivery (average 24 hours)
measure: Time to Active Labor During the First Hospital Admission
timeFrame: Interval from study drug administration to active labor (average 12 hours)
measure: Incidence of Pre-delivery Oxytocin During the First Hospital Admission
timeFrame: At least 30 minutes after study drug removal
measure: Incidence of Vaginal Delivery Within 12 Hours
timeFrame: Interval from study drug administration to vaginal delivery within 12 hours
measure: Incidence of Any Delivery Within 24 Hours
timeFrame: Interval from study drug administration to delivery of neonate within 24 hours
measure: Incidence of Any Delivery Within 12 Hours
timeFrame: Interval from study drug administration to delivery of neonate within 12 hours
measure: Incidence of Vaginal Delivery Within 24 Hours
timeFrame: Interval from study drug administration to vaginal delivery within 24 hours
measure: Incidence of Vaginal Delivery
timeFrame: Interval from study drug administration to vaginal delivery (average 24 hours)
measure: Rate of Adverse Events
timeFrame: From study drug administration to hospital discharge (approximately 48-72 hours)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Medical Center - District Medical Group
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Scottsdale
country: United States
facility: Phoenix Perinatal Associates (Scottsdale Healthcare Shea)
state: Arizona
city: Tucson
country: United States
facility: Watching Over Mothers and Babies Foundation
state: Arizona
city: Long Beach
country: United States
facility: Miller's Childrens Hospital
state: California
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: Fort Collins
country: United States
facility: The Women's Clinic of Northern Colorado
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health System (DE Center for MFM)
state: Delaware
city: Jacksonville
country: United States
facility: University of FL College of Medicine
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas School of Medicine
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: New Brunswick
country: United States
facility: St. Peters University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico/New Mexico Health Science Center
state: New Mexico
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University, Brody School of Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecologic Associates
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Eugene
country: United States
facility: Clinical Trials of America
state: Oregon
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: University Medical Group/Greenville Hospital System
state: South Carolina
city: Chattanooga
country: United States
facility: UT College of Medicine Chattanooga, Erlanger Health System
state: Tennessee
city: Knoxville
country: United States
facility: High Risk Obstetrical Consultants, PLLC
state: Tennessee
city: Memphis
country: United States
facility: Research Memphis Associates
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Sciences Center at Houston
state: Texas
city: Sandy
country: United States
facility: Salt Lake Women's Center, PC
state: Utah
city: Marshfield
country: United States
facility: Marshfield Clinic Research Foundation
state: Wisconsin
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Miller H, Goetzl L, Wing DA, Powers B, Rugarn O. Optimising daytime deliveries when inducing labour using prostaglandin vaginal inserts. J Matern Fetal Neonatal Med. 2016;29(4):517-22. doi: 10.3109/14767058.2015.1011117. Epub 2015 Mar 16.
citation: Wing DA, Brown R, Plante LA, Miller H, Rugarn O, Powers BL. Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2013 Aug;122(2 Pt 1):201-209. doi: 10.1097/AOG.0b013e31829a2dd6.