Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100) (Miso-Obs-203)

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.