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

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

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.

PK study in women requiring cervical ripening.

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.