Misoprostol Vaginal Insert (MVI) 100, 150, 200 Mcg for Cervical Ripening and Induction of Labor - Full Text View

Sponsored by:	Cytokine PharmaSciences
Information provided by:	Cytokine PharmaSciences
ClinicalTrials.gov Identifier:	NCT00828711

Purpose

Randomized, double blind, dose ranging study to assess the efficacy and safety of up to 24 hours treatment with the MVI 100, MVI 150 and MVI 200. Oxytocin may be used after removal of the study medication. There must be at least a 30 minute waiting interval between removing the study drug and commencing oxytocin. Patients will be stratified by parity and center. During treatment, women will be assessed for safety, onset of labor, and cervical ripening. Fetal heart rate patterns and uterine activity will be assessed via continuous CTG monitoring. Time to and mode of delivery of the neonate will be recorded. Modified Bishop score will be assessed at 6, 12, 18 and 24 hours after study drug insertion.

Condition	Intervention	Phase
Cervical Ripening Induction of Labor	Drug: MVI 100 Drug: MVI 150 Drug: MVI 200	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Dose-Ranging, Phase II Study to Assess the Efficacy and Safety of the 100, 150 and 200 Mcg Misoprostol Vaginal Insert for Women Requiring Cervical Ripening and Induction of Labor

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Misoprostol

U.S. FDA Resources

Further study details as provided by Cytokine PharmaSciences:

Primary Outcome Measures:

Proportion of women delivering vaginally [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to vaginal delivery [ Time Frame: Interval from insertion to delivery ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Proportion of cesarean delivery [ Time Frame: after insertion of study drug ] [ Designated as safety issue: Yes ]
Cervical ripening using composite measure of success [ Time Frame: 6, 12, 18 and 24h after insertion of drug ] [ Designated as safety issue: No ]
Vaginal delivery [ Time Frame: Within 12h after drug insertion ] [ Designated as safety issue: No ]
Use of oxytocin [ Time Frame: after study drug removal ] [ Designated as safety issue: No ]
pharmacokinetics [ Time Frame: During study drug insertion and after removal ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	April 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MVI 100 mcg vaginal insert	Drug: MVI 100 Hydrogel polymer vaginal insert with retrieval system, one 100 mcg insert for induction of labor, kept in place a maximum of 24h.
2: Experimental MVI 150 mcg vaginal insert	Drug: MVI 150 Hydrogel polymer vaginal insert with retrieval system, one 150 mcg insert for induction of labor, kept in place a maximum of 24h.
3: Experimental MVI 200 mcg vaginal insert	Drug: MVI 200 Hydrogel polymer vaginal insert with retrieval system, one 200 mcg insert for induction of labor, kept in place a maximum of 24h.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
Aged 18 years or older;
Candidate for pharmacologic 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);
BMI ≤ 50 at the time of entry to the study;
Written informed consent.

Exclusion Criteria:

Nulliparous women participating in the PK arm of the study: women with hemoglobin level < 11.0 g/dL (confirmed within one week of study drug insertion);
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 HELLP syndrome, other end-organ affliction or CNS findings other than mild headache;
Fetal malpresentation;
Diagnosed fetal abnormalities;
Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
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, other prostaglandins or any of the excipients;
Any condition urgently requiring delivery;
Unable to comply with the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828711

Locations

United States, Arizona
Precision Trials
Phoenix, Arizona, United States, 85032
Tuscon Medical Center
Tucson, Arizona, United States, 85716
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
UCI Medical Center
Orange, California, United States, 92868
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
United States, Colorado
Exempla St. Joseph Hospital
Denver, Colorado, United States, 80218
United States, New Mexico
University of New Mexico Medical Center
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Trident Health System
North Charleston, South Carolina, United States, 29406
United States, Tennessee
University of Tennesse Medical Center
Knoxville, Tennessee, United States, 37920

Memphis, Tennessee, United States, 38119
United States, Texas
University of Texas Health Sciences Center at Houston
Houston, Texas, United States, 77030

Sponsors and Collaborators

Cytokine PharmaSciences

Investigators

Principal Investigator:

William F Rayburn, MD

University of New Mexico

More Information

No publications provided

Responsible Party:	Cytokine PharmaSciences, Inc. ( Barbara Powers )
Study ID Numbers:	Miso-Obs-204
Study First Received:	January 22, 2009
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00828711 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cytokine PharmaSciences:

Misoprostol vaginal insert
Induction of labor
Cervical ripening
Rate of cesarean section

Study placed in the following topic categories:

Misoprostol

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Physiological Effects of Drugs
Abortifacient Agents

Misoprostol
Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009