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

Completed · Phase 3

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

In brief

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.

Key facts

Study ID

NCT01127581

Run by

Ferring Pharmaceuticals

People needed

1358

Starts

2010-09-01

Expected to finish

2012-03-01

Last updated by the study team

2014-05-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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