Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor

Induction of Labor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828711
• Other study ID #: Miso-Obs-204
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2009
• Last updated: March 10, 2014
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: March 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 assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• 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 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);

• Body Mass Index (BMI) = 50 at the time of entry to the study.

Exclusion Criteria:

• Nulliparous women participating in the pharmacokinetic (PK) arm of the study: women with hemoglobin level < 11.0 grams per deciliter (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 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 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.

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

Intervention

Drug:
• MVI 100
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 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.
• MVI 150
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 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.
• 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.

Locations

Country	Name	City	State
United States	University of New Mexico Medical Center	Albuquerque	New Mexico
United States	Duke University Medical Center	Durham	North Carolina
United States	Greenville Hospital System	Greenville	South Carolina
United States	University of Texas Health Sciences Center at Houston	Houston	Texas
United States	University of Tennesse Medical Center	Knoxville	Tennessee
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	UCI Medical Center	Orange	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Precision Trials	Phoenix	Arizona
United States	Tuscon Medical Center	Tucson	Arizona
United States	Forsyth Medical Center	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	Proportion of Women Delivering Vaginally		Interval from study drug administration to 24 hours	No
Secondary	Time to Vaginal Delivery		Interval from study drug administration to 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. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.	From study drug administration to hospital discharge (approximately 48 - 72 hours)	Yes
Secondary	Proportion of Cesarean Delivery		Interval from study drug administration to cesarean delivery (average 24 hours)	Yes
Secondary	Cervical Ripening Using Composite Measure of Success	Cervical ripening success was defined by achievement of one or more of the following by 12 hours after study drug administration: Increase from baseline in modified Bishop score =3; or; Achievement of modified Bishop score of =6; or; Vaginal delivery.	12 hours after insertion of drug	No
Secondary	Use of Oxytocin	Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure.	At least 30 minutes after study drug removal	No
Secondary	Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.	The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5, 1 and 2 hours after removal of the study drug.	From study drug insertion up to 2 hours post study drug removal	No
Secondary	Time to Onset of Active Labor		Interval from study drug administration to active labor (average 12 hours)	No