NCT03806231

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: Female
• Age: 18 Years – 41 Years
• Healthy volunteers: Accepted

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.

Conditions

• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2019-08-07
• Primary completion: 2019-12-05
• Completion: 2020-04-11
• First posted: 2019-01-16
• Last updated: 2021-09-05
• Results posted: 2021-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study