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

University Hospitals Cleveland Medical Center180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Cervical Ripening Induction of Labor Multiparity

Interventions

OxytocinDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Alison Bauer

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Time From Cervical Ripening to Delivery

Time from placement of cervical ripening balloon to delivery

Time frame: Time to delivery

Data from ClinicalTrials.gov

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