Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)

Study Overview
=================
Brief Summary
-----------------
This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and induction of labor.

Detailed Description
-----------------
PK study in women requiring cervical ripening.

Official Title
-----------------
A Multicenter, Open-Label, Phase II Study of the Pharmacokinetics and Safety of the100 Mcg Misoprostol Vaginal Insert (MVI 100) in Women Requiring Cervical Ripening and Induction of Labor

Conditions
-----------------
Cervical Ripening, Induction of Labor

Intervention / Treatment
-----------------
* Drug: Misoprostol Vaginal Insert (MVI 100)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women at ≥36 weeks 0 days inclusive gestation; Aged 18 years or older; Candidate for pharmacologic induction of labor; Singleton pregnancy; Baseline modified Bishop score <4 (see Appendix B); Nulliparous (nulliparous is defined as no previous births live or dead after 24 weeks gestation); Written informed consent. Exclusion Criteria: Women with hemoglobin level < 11.0 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 pregnancy inducted hypertension; Severe pre-eclampsia marked by CNS findings, HELLP syndrome, or other end-organ affliction; Suspected or confirmed cephalopelvic disproportion and/or fetal malpresentation; Diagnosed fetal abnormalities; Suspected or confirmed intrauterine growth retardation (less than 10% estimated fetal weight for dates); Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining); Receipt of NSAID (including aspirin) within 4 hours of study treatment; Ruptured membranes ≥48 hours prior to the start of treatment or suspected chorioamnionitis; Fever (oral or aural temperature > 37.5C); 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, dinoprostone, other prostaglandins or any of the excipients; Any condition urgently requiring delivery; Unable to comply with the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Misoprostol Vaginal Insert (MVI 100)<br>* The MVI 100 is misoprostol 100 mcg, formulated in a sustained release, nonbiodegradeable hydrogel polymer, with a polyester knit retrieval tape; IV oxytocin is permitted ad lib 30 minutes following removal of the MVI assuming no contraindications.<br>* Other names: Cervical ripener;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The levels of misoprostol acid in plasma at time points 0 (baseline), 2, 4, 6, 8, 10 and 14 hours. Not all patients will have all in situ time points as the insert may be removed earlier for safety or efficacy reasons. |  | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -The levels of misoprostol acid in plasma at time of removal, and 30 and 60 minutes post removal. -Assess all adverse events. |  | 24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical ripening, induction of labor