A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening
Condition: Induction of Labor Affected Fetus / Newborn
Intervention: Outpatient Dinoprostone 10mg; Inpatient Dinoprostone 10 mg
Intervention description: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.; Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.
Intervention MeSH terms: Dinoprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Maximum age: 41 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cervical Ripening

Summary:

      Induction of labor is a frequently planned obstetric procedure. Induction for women with an
      unfavorable cervix (bishop score <6) increases the risk of cesarean section. This risk may be
      reduced by ripening or softening the cervix before the induction of labor. This protocol
      outlines a randomized trial of 200 women evaluating the placement and use of Cervidil to the
      post vaginal fornix to soften the cervix in preparation for induction.

      This trial is looking at inpatient vs outpatient pre-induction cervical ripening using
      Cervidil and the effects on (1) maternal and newborn outcomes including time of admission to
      delivery, (2) system healthcare cost, (3) cost to patient, and (4) patient satisfaction.

      The investigators hypothesize when compared to patients admitted to the hospital for cervical
      ripening:

        1. From the time of admission, patients in the outpatient cervical ripening arm will
           progress to complete cervical dilation in less time.

        2. The total overall cost of care for the encounter will be reduced for the group in the
           outpatient cervical ripening arm.

        3. Patients in the outpatient cervical ripening arm will have more overall satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Accurate gestational age dating by Intermountain dating criteria placing the patient
             between 39 0/7 and 41 6/7 weeks gestational at time of cervical ripening

          -  Planning to undergo cervical ripening for induction of labor

          -  Participants must live <20 minutes away from the enrolling facility, or must stay < 20
             minutes away.

          -  Pregnant women between the ages of 18 and 41 at the time of enrollment.

          -  Fetus in vertex position

        Exclusion Criteria:

          -  Gestational age < 39 weeks or > 41 weeks and 6 days

          -  Hypertension (chronic, transitional, gestational, preeclampsia)

          -  Multiple gestation

          -  Intrauterine Growth Restriction

          -  Anticoagulant therapy or at high risk for thromboembolism

          -  Cardiac disease other than class I per American Heart Association (AHA)

          -  Prior incision in the contractile portion of the uterus

          -  Placenta previa

          -  Oligohydramnios per American College of Obstetricians and Gynecologists (ACOG)
             criteria: AFI < 5 or deepest vertical pocket <= 2

          -  Polyhydramnios per ACOG criteria: Amniotic Fluid Index (AFI) >= 24

          -  Cervical dilation >= 3cm

          -  Known fetal anomaly that would require advanced neonatal care

          -  Pitocin-induction of labor is otherwise contraindicated

          -  Patient is receiving other uterotonics (e.g. oxytocin, Cytotec, etc.)

          -  Fetal distress

          -  Unexplained vaginal bleeding during the pregnancy

          -  Sensitivity to prostaglandin

          -  Evidence of or suspicion of marked cephalo-pelvic disproportion (per the Cervidil
             package insert revision 02/2016, Ferring Pharmaceuticals Inc. Parsippany, NJ)