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

Ferring Pharmaceuticals24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Cervical Ripening Induction of Labor

Interventions

MVI 200DRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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; * 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.

Locations (1)

Huntington Memorial Hospital

Pasadena, California, United States

Outcomes

Primary Outcomes

Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion

The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 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 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.

Time frame: From study drug insertion up to 1 hour post study drug removal.

Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal

Time frame: From study drug insertion up to 1 hour post study drug removal

Secondary Outcomes

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.

Time frame: From study drug administration to hospital discharge (approximately 48-72 hours).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.