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

Phase 3

Completed

• Conditions: Cervical Ripening; Induction of Labor; Multiparity
• Interventions: Drug: Oxytocin

• Registration Number: NCT03138252
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-03
• Study Start: 2014-11
• Study First Submitted QC: 2017-04-30
• Study First Posted: 2017-05-03
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Results First Submitted: 2018-11-01
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Results First Posted: 2022-05-04
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical Ripening Balloon Alone	Oxytocin	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.
Cervical Ripening Balloon + Oxytocin	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.

Primary Outcome Measures

Name	Time	Method
Time From Cervical Ripening to Delivery	Time to delivery	Time from placement of cervical ripening balloon to delivery

Trial Locations

Locations (1)

Alison Bauer; 🇺🇸 Cleveland, Ohio, United States