A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening

Phase 3

Terminated

Interventions: Drug: Outpatient Dinoprostone 10mg
Drug: Inpatient Dinoprostone 10 mg

Brief 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Outpatient Cervical Ripening	Outpatient Dinoprostone 10mg	Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.
Inpatient Cervical Ripening	Inpatient Dinoprostone 10 mg	The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.

Primary Outcome Measures

Name	Time	Method
Dilation Completion Time	Time of admission to completion of dilation (up to 48 hours)	Time of admission for induction to complete dilation.
Total Cost of Induction Charged to Patient	Through study completion (up to 1 year)	Total hospital charges to patient, as obtained by Intermountain Healthcare billing

Secondary Outcome Measures

Name	Time	Method
Cesarean Delivery Rate	Through study completion (up to 1 year)	Number of patients enrolled who had a c-section delivery
Start of Oxytocin Until Delivery	Time oxytocin is administered to time of delivery (up to 24 hours)	Length of time between patient receiving oxytocin and delivery
Time of Delivery Until Discharge	Time of delivery to discharge (up to 96 hours)	Length of time between delivery and discharge.
Time of Admission Until Discharge	Time of admission to labor and delivery to discharge (up to 96 hours)	Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge
Patient Satisfaction: Survey	Time of delivery to discharge (up to 96 hours)	Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls.
Vaginal Delivery Rate	Through study completion (up to 1 year)	Number of patients enrolled who delivered vaginally
Operative Vaginal Delivery Rate	Through study completion (up to 1 year)	Number of patients enrolled who required an operative vaginal delivery