Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery (EXPEDITE)

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

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.

Study Overview

• Status: Completed
• Conditions: Induction of Labor; Cervical Ripening; Reducing Time to Vaginal Delivery
• Intervention / Treatment: Drug: MVI 200; Drug: Dinoprostone Vaginal Insert (DVI)

• Study Type: Interventional
• Enrollment (Actual): 1358
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
      • Maricopa Medical Center - District Medical Group
    • Phoenix, Arizona, United States
      • Precision Trials
    • Scottsdale, Arizona, United States
      • Phoenix Perinatal Associates (Scottsdale Healthcare Shea)
    • Tucson, Arizona, United States
      • Watching Over Mothers and Babies Foundation
  • California
    • Long Beach, California, United States
      • Miller's Childrens Hospital
    • Orange, California, United States
      • UCI Medical Center
  • Colorado
    • Fort Collins, Colorado, United States
      • The Women's Clinic of Northern Colorado
  • Delaware
    • Newark, Delaware, United States
      • Christiana Care Health System (DE Center for MFM)
  • Florida
    • Jacksonville, Florida, United States
      • University of FL College of Medicine
    • Lake Worth, Florida, United States
      • Altus Research
    • Tampa, Florida, United States
      • University of South Florida
  • Indiana
    • Indianapolis, Indiana, United States
      • Indiana University School of Medicine
  • Kansas
    • Kansas City, Kansas, United States
      • University of Kansas School of Medicine
  • Michigan
    • Ann Arbor, Michigan, United States
      • University of Michigan Hospital
    • Grand Rapids, Michigan, United States
      • Spectrum Health
  • Missouri
    • St. Louis, Missouri, United States
      • St. Louis University
  • New Jersey
    • New Brunswick, New Jersey, United States
      • St. Peters University Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States
      • University of New Mexico/New Mexico Health Science Center
  • North Carolina
    • Durham, North Carolina, United States
      • Duke University Medical Center
    • Greenville, North Carolina, United States
      • East Carolina University, Brody School of Medicine
    • Winston-Salem, North Carolina, United States
      • Lyndhurst Gynecologic Associates
  • Ohio
    • Cincinnati, Ohio, United States
      • University of Cincinnati
  • Oregon
    • Eugene, Oregon, United States
      • Clinical Trials of America
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States
      • Temple University School of Medicine
    • Philadelphia, Pennsylvania, United States
      • Drexel University College of Medicine
  • South Carolina
    • Charleston, South Carolina, United States
      • Medical University of South Carolina
    • Greenville, South Carolina, United States
      • University Medical Group/Greenville Hospital System
  • Tennessee
    • Chattanooga, Tennessee, United States
      • UT College of Medicine Chattanooga, Erlanger Health System
    • Knoxville, Tennessee, United States
      • High Risk Obstetrical Consultants, PLLC
    • Memphis, Tennessee, United States
      • Research Memphis Associates
  • Texas
    • Houston, Texas, United States
      • University of Texas Health Sciences Center at Houston
  • Utah
    • Sandy, Utah, United States
      • Salt Lake Women's Center, PC
  • Wisconsin
    • Marshfield, Wisconsin, United States
      • Marshfield Clinic Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MVI 200; MVI 200 mcg vaginal insert	Drug: MVI 200; Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.; Other Names: Misopess(TM); Misodel (R)
Active Comparator: Dinoprostone Vaginal Insert (DVI); 10 mg Dinoprostone vaginal insert	Drug: Dinoprostone Vaginal Insert (DVI); Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.; Other Names: Cervidil (R); Propess (R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Vaginal Delivery During the First Hospital Admission	Interval from study drug administration to vaginal delivery (average 24 hours)
Incidence of Cesarean Delivery During the First Hospital Admission	Interval from study drug administration to cesarean delivery (average 24 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission		Interval from study drug administration to neonate delivery (average 24 hours)
Time to Active Labor During the First Hospital Admission	Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more.	Interval from study drug administration to active labor (average 12 hours)
Incidence of Pre-delivery Oxytocin During the First Hospital Admission	Percentage of participants in receipt of Oxytocin for induction after study drug removal.	At least 30 minutes after study drug removal
Incidence of Vaginal Delivery Within 12 Hours		Interval from study drug administration to vaginal delivery within 12 hours
Incidence of Any Delivery Within 24 Hours		Interval from study drug administration to delivery of neonate within 24 hours
Incidence of Any Delivery Within 12 Hours		Interval from study drug administration to delivery of neonate within 12 hours
Incidence of Vaginal Delivery Within 24 Hours		Interval from study drug administration to vaginal delivery within 24 hours
Incidence of Vaginal Delivery		Interval from study drug administration to vaginal delivery (average 24 hours)
Rate of Adverse Events	All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug.	From study drug administration to hospital discharge (approximately 48-72 hours)

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: May 19, 2010
• First Submitted That Met QC Criteria: May 20, 2010
• First Posted (Estimate): May 21, 2010

Study Record Updates

• Last Update Posted (Estimate): May 1, 2014
• Last Update Submitted That Met QC Criteria: April 15, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Induction of labor; Cervical ripening; Dinoprostone vaginal insert; Cervidil; Misoprostol vaginal insert; Rate of cesarean section
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: Miso-Obs-303