Impact of Standardization on Outcomes Following Cervical Ripening
Starting soon · Phase 2/Phase 3
Conditions studied: Pregnancy
In brief
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 facts
- Study ID
- NCT07576881
- Run by
- Indiana University
- People needed
- 1158
- Starts
- 2026-06-01
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sidney & Lois Eskenazi Hospital — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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