Impact of Standardization on Outcomes Following Cervical Ripening

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Device: Cervical Ripening with a double balloon catheter only; Combination product: Cervical ripening with a double balloon catheter plus misoprostol; Combination product: Usual-care control group

Detailed Description

The goal of this study is to evaluate the impact of standardization of cervical ripening on labor outcomes as well as to evaluate whether different methods of cervical ripening influence labor outcomes The primary outcome will be SVD rate. Secondary outcomes will include time from admission to delivery, total duration of hospitalization (admission to discharge), operative vaginal delivery rate, incidence of delivery within 24 hours of admission, maximal dose of oxytocin (in mU/min), incidence of tachysystole requiring intervention, incidence of intervention for fetal bradycardia or "non-reassuring fetal status", maternal morbidity (endometritis, 3rd or 4th degree lacerations, hemorrhage >1000mL, blood transfusion, wound separation or infection or readmission), neonatal length of stay>3 days, NICU admission.

• Study Type: Interventional
• Enrollment (Estimated): 1158
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Sidney & Lois Eskenazi Hospital
      • Contact: Sarah M Carpenter, MD; Phone Number: 317-880-2229; Email: semorgan@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cervical Ripening with a double balloon catheter only	Device: Cervical Ripening with a double balloon catheter only; Labor induction will include cervical ripening with the use of a double balloon catheter without medication at the same time. After the balloon comes out (is taken out or falls out), the rest of the labor course will be managed by your provider
Experimental: Cervical ripening with a double balloon catheter plus misoprostol	Combination product: Cervical ripening with a double balloon catheter plus misoprostol; The labor induction will include cervical ripening with the use of a double balloon catheter and the medication misoprostol at the same time. After the balloon comes out (is taken out or falls out), the rest of your labor course will be managed by the provider.
Active Comparator: Usual-care control group; Cervical ripening will occur using the method chosen by your provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor.	Combination product: Usual-care control group; Cervical ripening will occur using the method chosen by the provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SVD rate	The primary outcome measure for this study is Spontaneous Vaginal Delivery (SVD) rate which is measured as the proportion of patients who deliver vaginally.	From enrollment until delivery, up to four days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SVD rate for study arm 1 versus study arm 2 (% difference)	Comparing (Spontaneous Vaginal Delivery) SVD rates between Cervical Ripening with a double balloon catheter only arm and Cervical ripening with a double balloon catheter plus misoprostol arm.	From enrollment until delivery, up to four days
Incidence of delivery within 24 hours of admission		Enrollment until delivery, up to four days
Incidence of tachysystole requiring intervention		Enrollment until study completion, up to 94 days
Incidence of intervention for fetal bradycardia or "non reassuring fetal status"		Enrollment until study completion, up to 94 days
Rate of Maternal endometritis		Enrollment until study completion, up to 94 days
Composite maternal morbidity	measured by % endometritis, 3rd or 4th degree lacerations, QBL >1000mL, intrapartum or postpartum blood transfusion, wound separation or infection, hospital readmission within 30 days after delivery	From delivery until 30 days after delivery
neonatal length of stay >3 days		From delivery until 3 days post delivery
Rate of NICU admission		From delivery until study completion, up to 94 days
Quantitative Blood Loss	blood loss measured in mL	From delivery until discharge, up to 4 days
Time from admission to delivery		From admission until delivery, up to four days
Total duration of hospitalization	Total duration of hospitalization measured from admission to discharge	From admission to discharge, up to 8 days

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana University Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: cervical ripening
• Additional Relevant MeSH Terms: Fatty Acids; Lipids; Biological Factors; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Prostaglandins E, Synthetic; Labor, Obstetric; Misoprostol; Cervical Ripening
• Other Study ID Numbers: 27548

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No