MedTrace Logo

Impact of Standardization on Outcomes Following Cervical Ripening

NCT07576881 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1158

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Pregnancy

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.

Sponsors & Collaborators

  • Indiana University Health

    collaborator OTHER

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2028-04-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07576881 on ClinicalTrials.gov