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

Induction of Labor Clinical Trial

— EXPEDITE  

Official title:

Phase III, Double-blind, Randomized, Multicenter Study of Exogenous Prostaglandin Comparing the Efficacy & Safety of the MVI 200 mcg Versus the Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery in Pregnant Women at Term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127581
• Other study ID #: Miso-Obs-303
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2010
• Last updated: April 15, 2014
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2014
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1358
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Induction of Labor
• Reducing Time to Vaginal Delivery

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of New Mexico/New Mexico Health Science Center	Albuquerque	New Mexico
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Medical University of South Carolina	Charleston	South Carolina
United States	UT College of Medicine Chattanooga, Erlanger Health System	Chattanooga	Tennessee
United States	University of Cincinnati	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Clinical Trials of America	Eugene	Oregon
United States	The Women's Clinic of Northern Colorado	Fort Collins	Colorado
United States	Spectrum Health	Grand Rapids	Michigan
United States	East Carolina University, Brody School of Medicine	Greenville	North Carolina
United States	University Medical Group/Greenville Hospital System	Greenville	South Carolina
United States	University of Texas Health Sciences Center at Houston	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of FL College of Medicine	Jacksonville	Florida
United States	University of Kansas School of Medicine	Kansas City	Kansas
United States	High Risk Obstetrical Consultants, PLLC	Knoxville	Tennessee
United States	Altus Research	Lake Worth	Florida
United States	Miller's Childrens Hospital	Long Beach	California
United States	Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Research Memphis Associates	Memphis	Tennessee
United States	St. Peters University Hospital	New Brunswick	New Jersey
United States	Christiana Care Health System (DE Center for MFM)	Newark	Delaware
United States	UCI Medical Center	Orange	California
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	Maricopa Medical Center - District Medical Group	Phoenix	Arizona
United States	Precision Trials	Phoenix	Arizona
United States	Salt Lake Women's Center, PC	Sandy	Utah
United States	Phoenix Perinatal Associates (Scottsdale Healthcare Shea)	Scottsdale	Arizona
United States	St. Louis University	St. Louis	Missouri
United States	University of South Florida	Tampa	Florida
United States	Watching Over Mothers and Babies Foundation	Tucson	Arizona
United States	Lyndhurst Gynecologic Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Vaginal Delivery During the First Hospital Admission		Interval from study drug administration to vaginal delivery (average 24 hours)	No
Primary	Incidence of Cesarean Delivery During the First Hospital Admission		Interval from study drug administration to cesarean delivery (average 24 hours)	Yes
Secondary	Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission		Interval from study drug administration to neonate delivery (average 24 hours)	No
Secondary	Time to Active Labor During the First Hospital Admission	Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more.	Interval from study drug administration to active labor (average 12 hours)	No
Secondary	Incidence of Pre-delivery Oxytocin During the First Hospital Admission	Percentage of participants in receipt of Oxytocin for induction after study drug removal.	At least 30 minutes after study drug removal	No
Secondary	Incidence of Vaginal Delivery Within 12 Hours		Interval from study drug administration to vaginal delivery within 12 hours	No
Secondary	Incidence of Any Delivery Within 24 Hours		Interval from study drug administration to delivery of neonate within 24 hours	No
Secondary	Incidence of Any Delivery Within 12 Hours		Interval from study drug administration to delivery of neonate within 12 hours	No
Secondary	Incidence of Vaginal Delivery Within 24 Hours		Interval from study drug administration to vaginal delivery within 24 hours	No
Secondary	Incidence of Vaginal Delivery		Interval from study drug administration to vaginal delivery (average 24 hours)	No
Secondary	Rate of Adverse Events	All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug.	From study drug administration to hospital discharge (approximately 48-72 hours)	Yes