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

University Hospitals (UH)

Status and phase: Completed; Phase 3

Conditions: Cervical Ripening; Multiparity; Induction of Labor

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT03138252

CRB + Oxytocin

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Cervical Ripening Balloon Alone

Active Comparator group

Description:

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.

Treatment:

Drug: Oxytocin

Cervical Ripening Balloon + Oxytocin

Active Comparator group

Description:

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.

Treatment:

Drug: Oxytocin