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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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn
Clinical Trial Details
NCT number NCT03806231
Study type Interventional
Source Intermountain Health Care, Inc.
Contact
Status Terminated
Phase Phase 3
Start date August 7, 2019
Completion date April 11, 2020
View Details
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