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

Phase 2

Completed

Conditions: Cervical Ripening
Induction of Labor

Interventions: Drug: MVI 100
Drug: MVI 150
Drug: MVI 200

Registration Number: NCT00828711

Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 374

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MVI 100	MVI 100	MVI 100 mcg vaginal insert
MVI 150	MVI 150	MVI 150 mcg vaginal insert
MVI 200	MVI 200	MVI 200 mcg vaginal insert

Primary Outcome Measures

Name	Time	Method
Proportion of Women Delivering Vaginally	Interval from study drug administration to 24 hours

Secondary Outcome Measures

Name	Time	Method
Time to Vaginal Delivery	Interval from study drug administration to delivery (average 24 hours)
Rate of Adverse Events	From study drug administration to hospital discharge (approximately 48 - 72 hours)	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.
Proportion of Cesarean Delivery	Interval from study drug administration to cesarean delivery (average 24 hours)
Cervical Ripening Using Composite Measure of Success	12 hours after insertion of drug	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.
Use of Oxytocin	At least 30 minutes after study drug removal	Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure.
Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.	From study drug insertion up to 2 hours post study drug removal	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.
Time to Onset of Active Labor	Interval from study drug administration to active labor (average 12 hours)

Trial Locations

Locations (11): University of Texas Health Sciences Center at Houston
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Houston, Texas, United States
Precision Trials
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Phoenix, Arizona, United States
Tuscon Medical Center
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Tucson, Arizona, United States
University of New Mexico Medical Center
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Albuquerque, New Mexico, United States
UCI Medical Center
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Orange, California, United States
University of Tennesse Medical Center
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Knoxville, Tennessee, United States
Temple University Hospital
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Philadelphia, Pennsylvania, United States
Forsyth Medical Center
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Winston-Salem, North Carolina, United States
Duke University Medical Center
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Durham, North Carolina, United States
Greenville Hospital System
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Greenville, South Carolina, United States
Long Beach Memorial Medical Center
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Long Beach, California, United States