Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
Condition: Reducing Time to Vaginal Delivery; Cervical Ripening; Induction of Labor
Intervention: MVI 200; Dinoprostone Vaginal Insert (DVI)
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.; Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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.
Intervention MeSH terms: Dinoprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1358.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Misoprostol vaginal insert; Dinoprostone vaginal insert; Cervidil; Cervical ripening; Induction of labor; Rate of cesarean section

Summary:

      The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200
      microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone
      Vaginal Insert (DVI) 10 milligram (mg) in pregnant 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 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.