Randomized Controlled Trial: Cervical Ripening Balloon With and Without Oxytocin for Cervical Ripening in Multiparas
Overview
- Phase
- Phase 3
- Intervention
- Oxytocin
- Conditions
- Cervical Ripening
- Sponsor
- University Hospitals Cleveland Medical Center
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Time From Cervical Ripening to Delivery
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Cervical Ripening Balloon Alone
Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Intervention: Oxytocin
Cervical Ripening Balloon + Oxytocin
Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Intervention: Oxytocin
Outcomes
Primary Outcomes
Time From Cervical Ripening to Delivery
Time Frame: Time to delivery
Time from placement of cervical ripening balloon to delivery