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

Phase 3

Completed

Conditions: Reducing Time to Vaginal Delivery
Induction of Labor
Cervical Ripening

Interventions: Drug: MVI 200
Drug: Dinoprostone Vaginal Insert (DVI)

Registration Number: NCT01127581

Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1358

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MVI 200	MVI 200	MVI 200 mcg vaginal insert
Dinoprostone Vaginal Insert (DVI)	Dinoprostone Vaginal Insert (DVI)	10 mg Dinoprostone vaginal insert

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of Vaginal Delivery	Interval from study drug administration to vaginal delivery (average 24 hours)
Time to Active Labor During the First Hospital Admission	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.
Incidence of Pre-delivery Oxytocin During the First Hospital Admission	At least 30 minutes after study drug removal	Percentage of participants in receipt of Oxytocin for induction 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
Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission	Interval from study drug administration to neonate delivery (average 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
Rate of Adverse Events	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.

Trial Locations

Locations (34): University of Kansas School of Medicine
🇺🇸
Kansas City, Kansas, United States
Precision Trials
🇺🇸
Phoenix, Arizona, United States
University of Cincinnati
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Cincinnati, Ohio, United States
Drexel University College of Medicine
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Philadelphia, Pennsylvania, United States
Miller's Childrens Hospital
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Long Beach, California, United States
The Women's Clinic of Northern Colorado
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Fort Collins, Colorado, United States
East Carolina University, Brody School of Medicine
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Greenville, North Carolina, United States
Maricopa Medical Center - District Medical Group
🇺🇸
Phoenix, Arizona, United States
Clinical Trials of America
🇺🇸
Eugene, Oregon, United States
St. Louis University
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St. Louis, Missouri, United States
Spectrum Health
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Grand Rapids, Michigan, United States
UCI Medical Center
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Orange, California, United States
Salt Lake Women's Center, PC
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Sandy, Utah, United States
High Risk Obstetrical Consultants, PLLC
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Knoxville, Tennessee, United States
University of Texas Health Sciences Center at Houston
🇺🇸
Houston, Texas, United States
Altus Research
🇺🇸
Lake Worth, Florida, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
University of New Mexico/New Mexico Health Science Center
🇺🇸
Albuquerque, New Mexico, United States
Marshfield Clinic Research Foundation
🇺🇸
Marshfield, Wisconsin, United States
Temple University School of Medicine
🇺🇸
Philadelphia, Pennsylvania, United States
Duke University Medical Center
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Durham, North Carolina, United States
Research Memphis Associates
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Memphis, Tennessee, United States
Watching Over Mothers and Babies Foundation
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Tucson, Arizona, United States
Indiana University School of Medicine
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Indianapolis, Indiana, United States
St. Peters University Hospital
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New Brunswick, New Jersey, United States
Phoenix Perinatal Associates (Scottsdale Healthcare Shea)
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Scottsdale, Arizona, United States
Christiana Care Health System (DE Center for MFM)
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Newark, Delaware, United States
UT College of Medicine Chattanooga, Erlanger Health System
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Chattanooga, Tennessee, United States
University of FL College of Medicine
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Jacksonville, Florida, United States
University of Michigan Hospital
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Ann Arbor, Michigan, United States
Lyndhurst Gynecologic Associates
🇺🇸
Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
University Medical Group/Greenville Hospital System
🇺🇸
Greenville, South Carolina, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States