Impact of Standardization on Outcomes Following Cervical Ripening

NCT07576881 | Not Yet Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: 27548
• Study Type: interventional
• Target: 1,158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

cervical ripening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• SVD rate for study arm 1 versus study arm 2 (% difference)

  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

Study Arms (3)

Cervical Ripening with a double balloon catheter only

EXPERIMENTAL

Device: Cervical Ripening with a double balloon catheter only

Cervical ripening with a double balloon catheter plus misoprostol

EXPERIMENTAL

Combination Product: Cervical ripening with a double balloon catheter plus misoprostol

Usual-care control group

ACTIVE COMPARATOR

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

Interventions

Cervical Ripening with a double balloon catheter only DEVICE

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

Cervical Ripening with a double balloon catheter only

Cervical ripening with a double balloon catheter plus misoprostol COMBINATION_PRODUCT

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.

Cervical ripening with a double balloon catheter plus misoprostol

Usual-care control group COMBINATION_PRODUCT

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.

Usual-care control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

Sidney & Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Cervical Ripening; Misoprostol

Intervention Hierarchy (Ancestors)

Labor, Obstetric; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

US (1)