drugset / Trial / NCT01991743

A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version

NCT01991743 ↗

Completed 240 enrolled Northwestern University
RandomizedParallel-groupDouble-blindTreatment

Summary

We plan to conduct a prospective, single blinded, randomized clinical trial to assess the impact of combined spinal-epidural dosing on the success rate of, and patient satisfaction during, external version for breech fetal position and the incidence of vaginal vs. Cesarean delivery. The research aim of this project is to determine the ideal neuraxial dosing strategy to maximize success of external cephalic version (ECV). The research questions, does a combined spinal-epidural (CSE) of a higher dose result in greater success in converting a breech presentation to vertex during external cephalic version (ECV). The hypotheses of this project is that CSE at higher dose will result in greater ECV success than analgesic dosing. The research significance:Increasing the success and comfort of ECV for fetal malpresentation may help decrease the cesarean section rate.

Timeline

Start
2011-05
Primary completion
2016-10
Completion
2017-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 2.5 mg Other
Comparator Bupivacaine Other / unclassified 5 mg Other
Comparator Bupivacaine Other / unclassified 7.5 mg Other
Comparator Bupivacaine Other / unclassified 10 mg Other

Indications