Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor

PHASE3CompletedINTERVENTIONAL
Enrollment

1,308

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

August 31, 2007

Study Completion Date

August 31, 2007

Conditions
Cervical RipeningLabor, Induced
Interventions
DRUG

Misoprostol vaginal insert 100 mcg

Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.

DRUG

Misoprostol vaginal insert 50 mcg

Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.

DRUG

Dinoprostone vaginal insert (Cervidil)

Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.

Trial Locations (52)

10016

NYU School of Medicine, New York

10032

Columbia University Medical Center, New York

10461

Jacobi Medical Center, The Bronx

11501

Winthrop-South Nassau University Health Center, Mineola

13790

United Health Services Hospitals, Inc., Johnson City

15213

University of Pittsburgh - Magee Women's Hospital, Pittsburgh

18103

Lehigh Valley Medical Center, Allentown

19090

Abington Memorial Hospital, Abington

19096

Lankenau Hospital, Wynnewood

19140

Temple University Hospital, Philadelphia

19718

Christiana Care Health System, Newark

27103

Women's Health Alliance, Winston-Salem

29406

Trident Health System, North Charleston

29605

Greenville Hospital System, Greenville

30005

Northside Hospital, Alpharetta

33401

St. Mary's Medical Center, West Palm Beach

33606

University of Florida Health Sciences Center, Tampa

33701

Bayfront Medical Center, St. Petersburg

35249

University of Alabama at Birmingham Medical Center, Birmingham

37403

Erlanger Hospital, Chattanooga

37920

University of Tennesse Medical Center, Knoxville

38119

Baptist Memorial Hospital, Memphis

43210

Ohio State University Medical Center, Columbus

45267

University of Cincinnati Holmes Hospital, Cincinnati

45409

Miami Valley Hospital, Dayton

48503

Hurley Medical Center, Flint

54476

Saint Clare's Hospital, Weston

55455

University of Minnesota Medical Center, Minneapolis

68510

St. Elizabeth Regional Medical Center, Lincoln

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75327

Methodist Charlton Medical Center, Dallas

76502

Kings Daughters Clinic, Temple

77030

University of Texas Health Sciences Center at Houston, Houston

84088

Jordan Valley Hospital, West Jordan

84120

Pioneer Valley Hospital, West Valley City

84124

St. Mark's Hospital, Salt Lake City

84132

University of Utah Health Science Center, Salt Lake City

84403

McKay-Dee Hospital, Ogden

85008

Maricopa Medical Center, Phoenix

85032

Arizona Wellness Center for Women, Phoenix

85202

Banner Desert Medical Center, Mesa

85716

Tuscon Medical Center, Tucson

87131

University of New Mexico Medical Center, Albuquerque

90806

Long Beach Memorial Medical Center, Long Beach

92868

UCI Medical Center, Orange

95128

Santa Clara Valley Medical Center, San Jose

97232

Legacy Center for Maternal-Fetal Medicine, Portland

98004

Overlake Hospital Medical Center, Bellevue

07962

Morristown Memorial Hospital, Morristown

A1B 3V6

Women's Health Centre/General Hospital/Eastern Health, St. John's

B3K 6R8

IWK Health Centre and Dalhousie University, Halifax

S7N 0W8

University of Saskatchewan Royal University Hospital, Saskatoon

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY

NCT00308711 - Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor | Biotech Hunter | Biotech Hunter