Does standardizing cervical ripening improve vaginal deliveries?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2/3 trial compares three approaches to cervical ripening in labor induction: double balloon catheter alone, double balloon catheter with misoprostol, and usual care. The primary outcome is the rate of spontaneous vaginal delivery, with secondary outcomes including time to delivery, total hospital stay, operative delivery, tachysystole, fetal status interventions, and maternal and neonatal morbidity and length of stay. The study enrolls pregnant patients at ≥37 weeks undergoing indicated or elective induction at Eskenazi Hospital, with consent and language access in English, Spanish, or Haitian Creole. Results will inform whether standardizing ripening methods improves labor outcomes and whether different methods have distinct effects on maternal and neonatal safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Sidney & Lois Eskenazi Hospital
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Study coordinator: Shelley Dowden, BS
• Email: sburn@iu.edu
• Phone: 317-880-3954

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.