Recruiting
Phase 2
Phase 3

Cervical Ripening

Sponsor:

Indiana University

Code:

NCT07576881

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cervical Ripening with a double balloon catheter only

Cervical ripening with a double balloon catheter plus misoprostol

Usual-care control group

Study Details

Brief 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

Study ID

NCT07576881

Start date

Jul 29, 2026

Status verified date

May, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients who are scheduled for medically indicated or elective induction of labor with gestational age ≥37 weeks at Eskenazi hospital
  • Willing and able to provide informed consent
  • Age ≥18 years old
  • Able to read, speak and understand English, Spanish or Haitian Creole

Exclusion Criteria:

  • Premature rupture of membranes
  • Known chorioamnionitis
  • Fetal malpresentation
  • Placenta previa
  • Category 3 fetal heart rate tracing -- only at the time of screening and enrollment. If a Category III tracing develops later in labor, this will prompt standard obstetric management, not removal from the study.
  • Prior uterine scar (cesarean delivery or other contraindication to use of prostaglandins)
  • Major fetal anomalies known at the time of enrollment that are expected to meaningfully impact labor management
  • Multiple gestation
  • Allergy to misoprostol or other contraindication to induction of labor or use of misoprostol or cook cervical ripening balloon
  • Patient does not require cervical ripening (SBS ≥ 6 or dilation ≥ 4cm)
  • Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

Study Design

Enrollment

1158 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Shelley Dowden, BS

317-880-3954sburn@iu.edu

Locations

Sidney & Lois Eskenazi Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sarah M Carpenter, MD

317-880-2229semorgan@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Oct 27, 2026

Last verified

May, 2026

Keywords

  • cervical ripening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Indiana University on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.