Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Indiana University Health | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical Ripening with a double balloon catheter only | Experimental |
| |
| Cervical ripening with a double balloon catheter plus misoprostol | Experimental |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SVD rate for study arm 1 versus study arm 2 (% difference) | 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. | From enrollment until delivery, up to four days |
| Incidence of delivery within 24 hours of admission |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney & Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States |
Not provided
| ID | Term |
|---|---|
| D020070 | Cervical Ripening |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D007743 | Labor, Obstetric |
| D011247 | Pregnancy |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 | 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 | From delivery until 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 | blood loss measured in mL | From delivery until discharge, up to 4 days |
| Time from admission to delivery | From admission until delivery, up to four days |
| Total duration of hospitalization | Total duration of hospitalization measured from admission to discharge | From admission to discharge, up to 8 days |
| D012101 |
| Reproductive and Urinary Physiological Phenomena |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |