NCT07576881
Impact of Standardization on Outcomes Following Cervical Ripening
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentIndiana UniversityInvestigator-initiated
~1,158 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Cervical Ripening with a double balloon catheter onlyCervical ripening with a double balloon catheter plus misoprostolUsual-care control group
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
SVD rate
Measured over From enrollment until delivery, up to four days
Conditions
Where it's being run
1 sites across 1 statesIndiana1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- SVD rateFrom enrollment until delivery, up to four days
The primary outcome measure for this study is Spontaneous Vaginal Delivery (SVD) rate which is measured as the proportion of patients who deliver vaginally.