Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)
Condition: Cervical Ripening; Induction of Labor
Intervention: MVI 200
Intervention description: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pharmacokinetics; Misoprostol Vaginal Insert; Induction of labor; Cervical Ripening; Rate of Cesarean section

Summary:

      The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for
      the MVI 200 in women requiring cervical ripening and induction of labor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent;

          -  Pregnant women at ≥ 36 weeks 0 days inclusive gestation;

          -  Women aged 18 years or older;

          -  Candidate for pharmacologic 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 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.