Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07576881

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sidney & Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location contact

Sarah M Carpenter, MD

CONTACT

[email protected]

317-880-2229

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

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.

Primary outcomes

  1. SVD rate

    Time frame: From 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.

Secondary outcomes

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

    Time frame: From enrollment until delivery, up to four days

    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.

  2. Incidence of delivery within 24 hours of admission

    Time frame: Enrollment until delivery, up to four days

  3. Incidence of tachysystole requiring intervention

    Time frame: Enrollment until study completion, up to 94 days

  4. Incidence of intervention for fetal bradycardia or "non reassuring fetal status"

    Time frame: Enrollment until study completion, up to 94 days

  5. Rate of Maternal endometritis

    Time frame: Enrollment until study completion, up to 94 days

  6. Composite maternal morbidity

    Time frame: From delivery until 30 days after delivery

    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

  7. neonatal length of stay >3 days

    Time frame: From delivery until 3 days post delivery

  8. Rate of NICU admission

    Time frame: From delivery until study completion, up to 94 days

  9. Quantitative Blood Loss

    Time frame: From delivery until discharge, up to 4 days

    blood loss measured in mL

  10. Time from admission to delivery

    Time frame: From admission until delivery, up to four days

  11. Total duration of hospitalization

    Time frame: From admission to discharge, up to 8 days

    Total duration of hospitalization measured from admission to discharge

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana University Health

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.