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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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.
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.
Dixie Regional Medical Center
St. George, Utah, United States
Dilation Completion Time
Time of admission for induction to complete dilation.
Time frame: 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
Time frame: Through study completion (up to 1 year)
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 frame: Time of delivery to discharge (up to 96 hours)
Vaginal Delivery Rate
Number of patients enrolled who delivered vaginally
Time frame: Through study completion (up to 1 year)
Operative Vaginal Delivery Rate
Number of patients enrolled who required an operative vaginal delivery
Time frame: Through study completion (up to 1 year)
Cesarean Delivery Rate
Number of patients enrolled who had a c-section delivery
Time frame: Through study completion (up to 1 year)
Start of Oxytocin Until Delivery
Length of time between patient receiving oxytocin and delivery
Time frame: 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 frame: 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 frame: Time of admission to labor and delivery to discharge (up to 96 hours)
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