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Impact of Standardization on Outcomes Following Cervical Ripening
RecruitingPhase 2/3Healthy volunteers welcome
Who can join
Ages 18 and older · Women · Healthy volunteers welcome
Full eligibility 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
About the study
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.
What is being tested
- Cervical Ripening with a double balloon catheter only (device)
- Cervical ripening with a double balloon catheter plus misoprostol (combination product)
- Usual-care control group (combination product)
Sponsor: Indiana University · Participants: 1,158 · Started: Jul 29, 2026
Contact the study team
- Shelley Dowden, BS · Phone: 317-880-3954
Official record on ClinicalTrials.gov — NCT07576881
Locations in the U.S.
| Indiana | Sidney & Lois Eskenazi Hospital, Indianapolis |
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.