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RecruitingAccepts healthy volunteersPhase 2/Phase 3

Impact of Standardization on Outcomes Following Cervical Ripening

Indiana University · with Indiana University Health · NCT07576881

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 2, Phase 3
Target enrollment
1158
US sites recruiting
1
Study start
July 29, 2026
Record last updated
October 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Cervical Ripening with a double balloon catheter only; Cervical ripening with a double balloon catheter plus misoprostol; Usual-care control group

Conditions: Pregnancy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Sidney & Lois Eskenazi Hospital

    Indianapolis, IN 46202

    Site contact: Sarah M Carpenter, MD · 317-880-2229 · semorgan@iu.edu

Study contacts (from the official record)

  • Shelley Dowden, BS · 317-880-3954 · sburn@iu.edu
All pregnancy studies in Indiana →
Impact of Standardization on Outcomes Following Cervical Ripening (NCT07576881) | Bored Studies