Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07576881
PHASE2/PHASE3

Impact of Standardization on Outcomes Following Cervical Ripening

Sponsor: Indiana University

View on ClinicalTrials.gov

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

DEVICE

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

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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