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

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.

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Key information

Conditions

Cervical Ripening Induction of Labor Multiparity

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Alison Bauer

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Primary outcomes

Time From Cervical Ripening to Delivery

Time frame: Time to delivery

Time from placement of cervical ripening balloon to delivery

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Randomized Controlled Trial: Cervical Ripening Balloon With and Without Oxytocin for Cervical Ripening in Multiparas

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: May 3, 2017
Registry last updated: May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed