Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix.

Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• Age > 18 years

• Gestational age > 34 + 0/7 weeks

• Prior spontaneous vaginal delivery

• Clinical or U/S EFW of <4500 grams

• Singleton gestation

• Cervical dilation <2 cm

Exclusion Criteria:

• Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery

• Placenta within 2 cm of cervical os

• Placental abruption, chorioamninoitis, or systemic infection prior to induction

• Rupture of membranes prior to induction ->1 prior C/S