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

Completed · Phase 3

Conditions studied: Cervical Ripening, Induction of Labor, Multiparity

In brief

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.

Key facts

Study ID

NCT03138252

Run by

University Hospitals Cleveland Medical Center

People needed

180

Starts

2014-11-01

Expected to finish

2017-07-01

Last updated by the study team

2022-05-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alison Bauer — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.