Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)

Exclusion Criteria

• •Women with hemoglobin level \< 10.0 grams per deciliter (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 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, other prostaglandins or any of the excipients;
• •Any condition urgently requiring delivery;
• •Unable to comply with the protocol.