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

Completed · Phase 2

Conditions studied: Cervical Ripening, Induction of Labor

In brief

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.

Key facts

Study ID

NCT00828711

Run by

Ferring Pharmaceuticals

People needed

374

Starts

2009-04-01

Expected to finish

2009-12-01

Last updated by the study team

2014-04-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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