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

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03806231
• Other study ID #: OutpatientCervidilTrial
• Status: Terminated
• Phase: Phase 3
• Start date: August 7, 2019
• Est. completion date: April 11, 2020

Study information

• Verified date: August 2021
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 11, 2020
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 41 Years

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)

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Dixie Regional Medical Center	Saint George	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Time of Admission to Postpartum	Length of stay on postpartum unit.	Time of admission to postpartum until discharge (up to 96 hours)
Other	NICU Admission	Length of time spent in NICU	Time of admission to NICU to discharge (up to 3 weeks)
Primary	Dilation Completion Time	Time of admission for induction to complete dilation.	Time of admission to completion of dilation (up to 48 hours)
Primary	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	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)
Secondary	Vaginal Delivery Rate	Number of patients enrolled who delivered vaginally	Through study completion (up to 1 year)
Secondary	Operative Vaginal Delivery Rate	Number of patients enrolled who required an operative vaginal delivery	Through study completion (up to 1 year)
Secondary	Cesarean Delivery Rate	Number of patients enrolled who had a c-section delivery	Through study completion (up to 1 year)
Secondary	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)
Secondary	Time of Delivery Until Discharge	Length of time between delivery and discharge.	Time of delivery to discharge (up to 96 hours)
Secondary	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)