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

April 15, 2014 updated by: Ferring Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1358

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time to Vaginal Delivery During the First Hospital Admission
Time Frame: Interval from study drug administration to vaginal delivery (average 24 hours)
Interval from study drug administration to vaginal delivery (average 24 hours)
Incidence of Cesarean Delivery During the First Hospital Admission
Time Frame: Interval from study drug administration to cesarean delivery (average 24 hours)
Interval from study drug administration to cesarean delivery (average 24 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission
Time Frame: Interval from study drug administration to neonate delivery (average 24 hours)
Interval from study drug administration to neonate delivery (average 24 hours)
Time to Active Labor During the First Hospital Admission
Time Frame: Interval from study drug administration to active labor (average 12 hours)
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
Time Frame: At least 30 minutes after study drug removal
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
Time Frame: Interval from study drug administration to vaginal delivery within 12 hours
Interval from study drug administration to vaginal delivery within 12 hours
Incidence of Any Delivery Within 24 Hours
Time Frame: Interval from study drug administration to delivery of neonate within 24 hours
Interval from study drug administration to delivery of neonate within 24 hours
Incidence of Any Delivery Within 12 Hours
Time Frame: Interval from study drug administration to delivery of neonate within 12 hours
Interval from study drug administration to delivery of neonate within 12 hours
Incidence of Vaginal Delivery Within 24 Hours
Time Frame: Interval from study drug administration to vaginal delivery within 24 hours
Interval from study drug administration to vaginal delivery within 24 hours
Incidence of Vaginal Delivery
Time Frame: Interval from study drug administration to vaginal delivery (average 24 hours)
Interval from study drug administration to vaginal delivery (average 24 hours)
Rate of Adverse Events
Time Frame: From study drug administration to hospital discharge (approximately 48-72 hours)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Miso-Obs-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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