Impact of Standardization on Outcomes Following Cervical Ripening

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07576881
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Cervical Ripening with a double balloon catheter only — DEVICE
    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 — COMBINATION_PRODUCT
    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 — COMBINATION_PRODUCT
    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.

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
1,158 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cervical Ripening with a double balloon catheter only
  • Experimental: Cervical ripening with a double balloon catheter plus misoprostol
  • Active Comparator: Usual-care control group
    Cervical ripening will occur using the method chosen by your 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.

Primary Outcome Measure

SVD rate [ Time Frame: From enrollment until delivery, up to four days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney & Lois Eskenazi HospitalIndianapolisIndiana46202
Sarah M Carpenter, MD
[email protected]
317-880-2229

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By research site
Sidney & Lois Eskenazi Hospital· Indianapolis, IN

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