Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor
Condition: Cervical Ripening; Induction of Labor
Intervention: MVI 100; MVI 150; MVI 200
Intervention description: Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 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.; Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 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.; 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: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 374.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Misoprostol vaginal insert; Induction of labor; Cervical ripening; Rate of cesarean section

Summary:

      The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg
      Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for 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:

          -  Nulliparous women participating in the pharmacokinetic (PK) arm of the study: women
             with hemoglobin level < 11.0 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 fetal abnormalities;

          -  Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate
             pattern or meconium staining);

          -  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.