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

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.