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Impact of Standardization on Outcomes Following Cervical Ripening
Sponsor: Indiana University
Summary
The primary purpose of this study is to determine if vaginal delivery rate is impacted by the use of standardized methods of cervical ripening. Additional outcomes will be evaluated including maternal and fetal outcomes of labor.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1158
Start Date
2026-06
Completion Date
2028-04
Last Updated
2026-05-08
Healthy Volunteers
Yes
Conditions
Interventions
Cervical Ripening with a double balloon catheter only
Labor induction will include cervical ripening with the use of a double balloon catheter without medication at the same time. After the balloon comes out (is taken out or falls out), the rest of the labor course will be managed by your provider
Cervical ripening with a double balloon catheter plus misoprostol
The labor induction will include cervical ripening with the use of a double balloon catheter and the medication misoprostol at the same time. After the balloon comes out (is taken out or falls out), the rest of your labor course will be managed by the provider.
Usual-care control group
Cervical ripening will occur using the method chosen by the provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor.
Locations (1)
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, United States