Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
NCT ID: NCT01127581
Last Updated: 2014-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1358 participants
INTERVENTIONAL
2010-09-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MVI 200
MVI 200 mcg vaginal insert
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.
Dinoprostone Vaginal Insert (DVI)
10 mg Dinoprostone vaginal insert
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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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
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University Medical Group/Greenville Hospital System
Greenville, South Carolina, United States
UT College of Medicine Chattanooga, Erlanger Health System
Chattanooga, Tennessee, United States
High Risk Obstetrical Consultants, PLLC
Knoxville, Tennessee, United States
Research Memphis Associates
Memphis, Tennessee, United States
University of Texas Health Sciences Center at Houston
Houston, Texas, United States
Salt Lake Women's Center, PC
Sandy City, Utah, United States
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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Miso-Obs-303
Identifier Type: -
Identifier Source: org_study_id
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