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

NCT ID: NCT03806231

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-07
• Study Completion Date: 2020-04-11

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.

Conditions

Induction of Labor Affected Fetus / Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Outpatient Dinoprostone 10mg

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Inpatient Dinoprostone 10 mg

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Outpatient Cervidil; Inpatient Cervidil

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Nichols, DO

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Locations

Dixie Regional Medical Center

St. George, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32852803 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OutpatientCervidilTrial

Identifier Type: -

Identifier Source: org_study_id