Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery

Inclusion Criteria: * Provide written informed consent; * Pregnant women at ≥ 36 weeks 0 days inclusive gestation; * Women aged 18 years or older; * Candidate for pharmacological 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 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, dinoprostone, other prostaglandins or any of the excipients; * Any condition urgently requiring delivery; * Unable to comply with the protocol.