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COMPLETEDPHASE2

Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)

A Multicenter, Open-Label, Phase II Study of the 200 mcg Misoprostol Vaginal Insert (MVI 200) to Obtain Pharmacokinetics in Women at Term Gestation (The MVI-PK Study)

NCT01283022•Ferring Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for the MVI 200 in women requiring cervical ripening and induction of labor.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

•Women with hemoglobin level \< 10.0 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 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;
+6 more criteria

Locations (1)

Huntington Memorial Hospital

Pasadena, California, United States

Key Dates

Start Date

May 1, 2011

Primary Completion Date

July 1, 2011

Completion Date

July 1, 2011

Last Updated

April 14, 2014

Enrollment

ACTUAL participants

Conditions

Cervical RipeningInduction of Labor

Interventions

MVI 200

DRUG

Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter

NCT06803992

Induction of Labor

View study

RECRUITINGNA

Membrane Stripping for Cervical Ripening

NCT06591247

Labor, InducedCervical Ripening+3 more

View study

NOT_YET_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)

Inclusion Criteria

Exclusion Criteria

Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter

Membrane Stripping for Cervical Ripening

Combined Nipple Stimulation and Foley Balloon for Cervical Ripening

Latent Phase Membrane Stripping for Caesarean Section Reduction

Methods of Labor Induction and Perinatal Outcomes

Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term