Impact of Standardization on Outcomes Following Cervical Ripening (NCT07576881) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Impact of Standardization on Outcomes Following Cervical Ripening
United States1,158 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
SVD rate
Timeframe: From enrollment until delivery, up to four days