A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version
Completed · Not applicable
Conditions studied: Pregnancy, Pain
In brief
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.
Key facts
- Study ID
- NCT01991743
- Run by
- Northwestern University
- People needed
- 240
- Starts
- 2011-05-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2020-01-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Healthy patients age 18 and older
- Breech presentation
- Singleton gestation .scheduled for ECV desiring CSE.
You may not qualify if…
- Refusal
- Contraindication to neuraxial (coagulopathy, anticoagulant use, local infection, sepsis etc) .Rupture of membranes.
- Drop-out: Patients may choose to drop-out of the study at any time. The physicians involved in this study may choose to end a patient's involvement in the study at their discretion.
Where it is running
- Prentice Women's Hospital — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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