Overview

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

Status:
Terminated
Trial end date:
2020-04-11
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborator:
Ferring Pharmaceuticals
Treatments:
Dinoprostone