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

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

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.

Study Overview

• Status: Terminated
• Conditions: Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Drug: Outpatient Dinoprostone 10mg; Drug: Inpatient Dinoprostone 10 mg

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Utah
    • Saint George, Utah, United States, 84790
      • Dixie Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient Cervical Ripening; 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; 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.; Other Names: Outpatient Cervidil
Active Comparator: Inpatient Cervical Ripening; 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; 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.; Other Names: Inpatient Cervidil

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant 5 Minute APGAR Score	APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health.	From delivery to 5 minutes following delivery
Time of Admission to Postpartum	Length of stay on postpartum unit.	Time of admission to postpartum until discharge (up to 96 hours)
NICU Admission	Length of time spent in NICU	Time of admission to NICU to discharge (up to 3 weeks)

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: Ferring Pharmaceuticals
• Investigators: Principal Investigator: John Nichols, DO, Intermountain Health Care, Inc.

Publications and helpful links

General Publications

• Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): April 11, 2020

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cervical Ripening
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: OutpatientCervidilTrial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No