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

Study Overview
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Brief Summary
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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: From the time of admission, patients in the outpatient cervical ripening arm will progress to complete cervical dilation in less time. The total overall cost of care for the encounter will be reduced for the group in the outpatient cervical ripening arm. Patients in the outpatient cervical ripening arm will have more overall satisfaction.

Official Title
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A Trial of Cervidil (Dinoprostone, Prostaglandin E2 (PGE2), Insert) for Outpatient Pre-induction of Cervical Ripening in Women at 39.0-41.6 Weeks Gestation

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Drug: Outpatient Dinoprostone 10mg
* Drug: Inpatient Dinoprostone 10 mg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient Cervical Ripening<br>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. | Drug: Outpatient Dinoprostone 10mg<br>* 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.<br>* Other names: Outpatient Cervidil;|
| Active Comparator: Inpatient Cervical Ripening<br>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. | Drug: Inpatient Dinoprostone 10 mg<br>* 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.<br>* Other names: Inpatient Cervidil;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction: Survey | 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. | Time of delivery to discharge (up to 96 hours) | 
| Vaginal Delivery Rate | Number of patients enrolled who delivered vaginally | Through study completion (up to 1 year) | 
| Operative Vaginal Delivery Rate | Number of patients enrolled who required an operative vaginal delivery | Through study completion (up to 1 year) | 
| Cesarean Delivery Rate | Number of patients enrolled who had a c-section delivery | Through study completion (up to 1 year) | 
| Start of Oxytocin Until Delivery | Length of time between patient receiving oxytocin and delivery | Time oxytocin is administered to time of delivery (up to 24 hours) | 
| Time of Delivery Until Discharge | Length of time between delivery and discharge. | Time of delivery to discharge (up to 96 hours) | 
| Time of Admission Until Discharge | Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge | Time of admission to labor and delivery to discharge (up to 96 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Ripening