Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
NCT Number: NCT07576881
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Phase 2 / Phase 3
Indianapolis, Indiana, 46202, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
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.
Time frame: Enrollment until delivery, up to four days
Time frame: Enrollment until study completion, up to 94 days
Time frame: Enrollment until study completion, up to 94 days
Time frame: Enrollment until study completion, up to 94 days
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
Time frame: From delivery until 3 days post delivery
Time frame: From delivery until study completion, up to 94 days
Time frame: From delivery until discharge, up to 4 days
blood loss measured in mL
Time frame: From admission until delivery, up to four days
Time frame: From admission to discharge, up to 8 days
Total duration of hospitalization measured from admission to discharge
Indiana University
Other
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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.
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