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

Inclusion Criteria:

• Provide written informed consent;
• Pregnant women at ≥36 weeks 0 days inclusive gestation;
• Parity ≤3;
• Women aged ≥18 years;
• Candidate for pharmacologic induction of labor;
• Single, live vertex fetus;
• Body Mass Index (BMI) ≤50 at the time of entry to the study;
• Baseline modified Bishop score ≤4.

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;

• Administration of any of the following within 7 days prior to study drug administration:

  • Oxytocin;
  • Any cervical ripening or labor inducing agents (including mechanical methods, e.g., intracervical Foley bulb use);
  • Tocolytic drug; Magnesium sulfate is permitted if prescribed as treatment for preeclampsia or gestational hypertension;
• Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
• Any evidence of fetal compromise at baseline (e.g., failed non-stress or stress test, meconium staining or diagnosis or history of non-reassuring fetal status); Fetal growth restriction (less 10%), polyhydramnios and oligohydramnios are not considered evidence of fetal compromise and are permitted.
• Presence of uterine or cervical scar; loop electrosurgical excision procedure (LEEPs) and other cervical biopsies, including cold-knife cone or punch biopsy of the cervix, are permitted;
• Presence of uterine abnormality (e.g., bicornate uterus);
• Severe preeclampsia marked by hemolysis, elevated liver enzymes, low platelets (HELLP syndrome), other end-organ affliction or central nervous system (CNS) findings other than mild headache;
• Fetal malpresentation;
• Diagnosed congenital anomalies, not including polydactyly;
• Ruptured membranes ≥48 hours prior to study drug administration;
• Signs or symptoms of chorioamnionitis (e.g., temperature >99.5°F/37.5°C, uterine tenderness, purulent vaginal discharge, or persistent maternal or fetal tachycardia);
• Fever (oral or aural temperature >99.5°F/37.5°C);
• Any unexplained vaginal bleeding at any time after 24 weeks 0 days gestation during this pregnancy;
• Any condition in which vaginal delivery is contraindicated (e.g., placenta previa);
• 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.