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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,358

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Reducing Time to Vaginal DeliveryCervical RipeningInduction of Labor
Interventions
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.

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.

Trial Locations (34)

Unknown

Maricopa Medical Center - District Medical Group, Phoenix

Precision Trials, Phoenix

Phoenix Perinatal Associates (Scottsdale Healthcare Shea), Scottsdale

Watching Over Mothers and Babies Foundation, Tucson

Miller's Childrens Hospital, Long Beach

UCI Medical Center, Orange

The Women's Clinic of Northern Colorado, Fort Collins

Christiana Care Health System (DE Center for MFM), Newark

University of FL College of Medicine, Jacksonville

Altus Research, Lake Worth

University of South Florida, Tampa

Indiana University School of Medicine, Indianapolis

University of Kansas School of Medicine, Kansas City

University of Michigan Hospital, Ann Arbor

Spectrum Health, Grand Rapids

St. Louis University, St Louis

St. Peters University Hospital, New Brunswick

University of New Mexico/New Mexico Health Science Center, Albuquerque

Duke University Medical Center, Durham

East Carolina University, Brody School of Medicine, Greenville

Lyndhurst Gynecologic Associates, Winston-Salem

University of Cincinnati, Cincinnati

Clinical Trials of America, Eugene

Drexel University College of Medicine, Philadelphia

Temple University School of Medicine, Philadelphia

Thomas Jefferson University, Philadelphia

Medical University of South Carolina, Charleston

University Medical Group/Greenville Hospital System, Greenville

UT College of Medicine Chattanooga, Erlanger Health System, Chattanooga

High Risk Obstetrical Consultants, PLLC, Knoxville

Research Memphis Associates, Memphis

University of Texas Health Sciences Center at Houston, Houston

Salt Lake Women's Center, PC, Sandy City

Marshfield Clinic Research Foundation, Marshfield

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY