Impact of Standardization on Outcomes Following Cervical Ripening
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Indiana University
- Enrollment
- 1,158
- Locations
- 1
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Cervical Ripening with a double balloon catheter only
Intervention: Cervical Ripening with a double balloon catheter only (Device)
Cervical ripening with a double balloon catheter plus misoprostol
Intervention: Cervical ripening with a double balloon catheter plus misoprostol (Combination Product)
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.
Intervention: Usual-care control group (Combination Product)
Investigators
Sarah Morgan Carpenter
MD
Indiana University