Clinical trial NCT03806231: A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Induction of Labor Affected Fetus / Newborn
Keywords: Cervical Ripening
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2019-01-16
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Dilation Completion Time
timeFrame: Time of admission to completion of dilation (up to 48 hours)
measure: Total Cost of Induction Charged to Patient
timeFrame: Through study completion (up to 1 year)
Secondary outcomes:
measure: Patient Satisfaction: Survey
timeFrame: Time of delivery to discharge (up to 96 hours)
measure: Vaginal Delivery Rate
timeFrame: Through study completion (up to 1 year)
measure: Operative Vaginal Delivery Rate
timeFrame: Through study completion (up to 1 year)
measure: Cesarean Delivery Rate
timeFrame: Through study completion (up to 1 year)
measure: Start of Oxytocin Until Delivery
timeFrame: Time oxytocin is administered to time of delivery (up to 24 hours)
measure: Time of Delivery Until Discharge
timeFrame: Time of delivery to discharge (up to 96 hours)
measure: Time of Admission Until Discharge
timeFrame: Time of admission to labor and delivery to discharge (up to 96 hours)
Other outcomes:
measure: Infant 5 Minute APGAR Score
timeFrame: From delivery to 5 minutes following delivery
measure: Time of Admission to Postpartum
timeFrame: Time of admission to postpartum until discharge (up to 96 hours)
measure: NICU Admission
timeFrame: Time of admission to NICU to discharge (up to 3 weeks)
Locations:
city: Saint George
country: United States
facility: Dixie Regional Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: John Nichols, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.