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

NCT03806231 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: OutpatientCervidilTrial
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Induction of Labor Affected Fetus / Newborn

Keywords

Cervical Ripening

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Patient Satisfaction: Survey

  Time of delivery to discharge (up to 96 hours)

• Vaginal Delivery Rate

  Through study completion (up to 1 year)

• Operative Vaginal Delivery Rate

  Through study completion (up to 1 year)

• Cesarean Delivery Rate

  Through study completion (up to 1 year)

• Start of Oxytocin Until Delivery

  Time oxytocin is administered to time of delivery (up to 24 hours)

Other Outcomes (3)

• Infant 5 Minute APGAR Score

  From delivery to 5 minutes following delivery

• Time of Admission to Postpartum

  Time of admission to postpartum until discharge (up to 96 hours)

• NICU Admission

  Time of admission to NICU to discharge (up to 3 weeks)

Study Arms (2)

Outpatient Cervical Ripening

EXPERIMENTAL

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

Inpatient Cervical Ripening

ACTIVE COMPARATOR

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

Interventions

Outpatient Dinoprostone 10mg DRUG

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.

Also known as: Outpatient Cervidil

Outpatient Cervical Ripening

Inpatient Dinoprostone 10 mg DRUG

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.

Also known as: Inpatient Cervidil

Inpatient Cervical Ripening

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Dixie Regional Medical Center

St. George, Utah, 84790, United States

Location

Related Publications (1)

• 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.

  PMID: 32852803 DERIVED

Limitations and Caveats

Trial terminated prior to meeting sufficient sample size for outcome analyses.

Results Point of Contact

• Title: Molly Adams, Clinical Research Project Coordinator
• Organization: Intermountain Healthcare

molly.adams@imail.org

(801)507-7030

Study Officials

• John Nichols, DO

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: January 16, 2019
• Study Start: August 7, 2019
• Primary Completion: December 5, 2019
• Study Completion: April 11, 2020
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)