Pregnancy
Conditions
Keywords
cervical ripening
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.
Interventions
DEVICECervical 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_PRODUCTCervical 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_PRODUCTUsual-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.
Sponsors
Indiana University
Indiana University Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SVD rate | 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
| Measure | Time frame | Description |
|---|---|---|
| SVD rate for study arm 1 versus study arm 2 (% difference) | 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. |
| 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 | 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 |
| 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 | From delivery until discharge, up to 4 days | blood loss measured in mL |
| Time from admission to delivery | From admission until delivery, up to four days | — |
| Total duration of hospitalization | From admission to discharge, up to 8 days | Total duration of hospitalization measured from admission to discharge |
Countries
United States
Outcome results
None listed