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

NCT01127581 | Completed Phase 3 Results DMC

• 1 other identifier: Miso-Obs-303
• Study Type: interventional
• Target: 1,358
• Locations: 1 country
• Sites: 34

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

  Interval from study drug administration to active labor (average 12 hours)

• Incidence of Pre-delivery Oxytocin During the First Hospital Admission

  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

Study Arms (2)

MVI 200

EXPERIMENTAL

MVI 200 mcg vaginal insert

Drug: MVI 200

Dinoprostone Vaginal Insert (DVI)

ACTIVE COMPARATOR

10 mg Dinoprostone vaginal insert

Drug: Dinoprostone Vaginal Insert (DVI)

Interventions

MVI 200 DRUG

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.

Also known as: Misopess(TM), Misodel (R)

MVI 200

Dinoprostone Vaginal Insert (DVI) DRUG

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.

Also known as: Cervidil (R), Propess (R)

Dinoprostone Vaginal Insert (DVI)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (34)

Maricopa Medical Center - District Medical Group

Phoenix, Arizona, United States

Location

Precision Trials

Phoenix, Arizona, United States

Location

Phoenix Perinatal Associates (Scottsdale Healthcare Shea)

Scottsdale, Arizona, United States

Location

Watching Over Mothers and Babies Foundation

Tucson, Arizona, United States

Location

Miller's Childrens Hospital

Long Beach, California, United States

Location

UCI Medical Center

Orange, California, United States

Location

The Women's Clinic of Northern Colorado

Fort Collins, Colorado, United States

Location

Christiana Care Health System (DE Center for MFM)

Newark, Delaware, United States

Location

University of FL College of Medicine

Jacksonville, Florida, United States

Location

Altus Research

Lake Worth, Florida, United States

Location

University of South Florida

Tampa, Florida, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, United States

Location

University of Kansas School of Medicine

Kansas City, Kansas, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, United States

Location

Spectrum Health

Grand Rapids, Michigan, United States

Location

St. Louis University

St Louis, Missouri, United States

Location

St. Peters University Hospital

New Brunswick, New Jersey, United States

Location

University of New Mexico/New Mexico Health Science Center

Albuquerque, New Mexico, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

East Carolina University, Brody School of Medicine

Greenville, North Carolina, United States

Location

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, United States

Location

University of Cincinnati

Cincinnati, Ohio, United States

Location

Clinical Trials of America

Eugene, Oregon, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Location

Medical University of South Carolina

Charleston, South Carolina, United States

Location

University Medical Group/Greenville Hospital System

Greenville, South Carolina, United States

Location

UT College of Medicine Chattanooga, Erlanger Health System

Chattanooga, Tennessee, United States

Location

High Risk Obstetrical Consultants, PLLC

Knoxville, Tennessee, United States

Location

Research Memphis Associates

Memphis, Tennessee, United States

Location

University of Texas Health Sciences Center at Houston

Houston, Texas, United States

Location

Salt Lake Women's Center, PC

Sandy City, Utah, United States

Location

Marshfield Clinic Research Foundation

Marshfield, Wisconsin, United States

Location

Related Publications (2)

• 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.

  PMID: 25758619 DERIVED

• 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.

  PMID: 23857539 DERIVED

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 21, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 1, 2014
• Results First Posted: March 7, 2014

Record last verified: 2014-04

Locations

US (34)