Impact of Standardization on Outcomes Following Cervical Ripening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cervical Ripening with a double balloon catheter only, Cervical ripening with a double balloon catheter plus misoprostol, Usual-care control group.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 - 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. - 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.
Primary outcome measures
- SVD rate [Time frame: From enrollment until delivery, up to four days]
Secondary outcome measures (11)
- SVD rate for study arm 1 versus study arm 2 (% difference) [Time frame: From enrollment until delivery, up to four days]
- Incidence of delivery within 24 hours of admission [Time frame: Enrollment until delivery, up to four days]
- Incidence of tachysystole requiring intervention [Time frame: Enrollment until study completion, up to 94 days]
- Incidence of intervention for fetal bradycardia or "non reassuring fetal status" [Time frame: Enrollment until study completion, up to 94 days]
- Rate of Maternal endometritis [Time frame: Enrollment until study completion, up to 94 days]
- Composite maternal morbidity [Time frame: From delivery until 30 days after delivery]
- neonatal length of stay >3 days [Time frame: From delivery until 3 days post delivery]
- Rate of NICU admission [Time frame: From delivery until study completion, up to 94 days]
- Quantitative Blood Loss [Time frame: From delivery until discharge, up to 4 days]
- Time from admission to delivery [Time frame: From admission until delivery, up to four days]
- Total duration of hospitalization [Time frame: From admission to discharge, up to 8 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Sidney & Lois Eskenazi Hospital — Indianapolis
Identifiers
NCT: NCT07576881 · 27548