Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening

• Status: Completed
• Trial end date: 2020-07-24
• Target enrollment: 0
• Participant gender: Female

Summary

In term women presenting for labor induction, combined use of the controlled release dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median time from induction to vaginal delivery by at least four hours compared to the Foley catheter alone.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: Ferring Pharmaceuticals
• Treatments: Dinoprostone

Criteria

Inclusion Criteria:

1. Cervix ≤2 cm dilated; if 2 cm, <80% effaced

2. Gestational age 37 weeks or more

3. Singleton gestation

4. Cephalic presentation

5. Live fetus

Exclusion Criteria:

1. Contractions more frequent than every 5 minutes

2. Premature rupture of membranes

3. Prior uterine incision

4. Temperature 38C or higher

5. Fetal anomalies

6. Placenta previa

7. Suspected abruption or undiagnosed bleeding more than spotting

8. Fetal heart rate tracing prior to enrollment with no more than minimal variability, late decelerations, or more than two variable decelerations

9. HIV infection

10. Allergy to either latex or dinoprostone