Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version
The purpose of this study is to examine whether spinal anesthesia affects the chances of successful external cephalic version (ECV) of a breech presenting fetus.
Two study groups will be included; one will receive spinal anesthesia, the other will not. The non-spinal group will be permitted to cross over if ECV procedure is painful.
The main outcome is success of ECV.
|Breech Presentation||Procedure: External cephalic version with and without spinal anesthesia||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Study to Examine the Success Rate of External Cephalic Version for Breech Presentation at Term Presentation: Spinal Analgesia Versus No Analgesia|
- Conversion of a breech to a vertex presentation [ Time Frame: 4-6 years ]
- Complications associated with ECV: Premature rupture of membranes, Contractions, Placental abruption, Fetal distress, Pain score during procedure (VAS Scale 0 = no pain, 10 = severe pain). [ Time Frame: 4-6 years ]
- Complications associated with analgesia: Severe maternal hypotension (>20 reduction in systolic BP), Fetal distress (prior to performance of ECV), Post Dural Puncture Headache, Failure of analgesia. [ Time Frame: 4-6 years ]
- Inability to perform procedure due to maternal distress or discomfort. [ Time Frame: 4-6 years ]
- Mode of delivery and date from the ECV. [ Time Frame: 4-6 years ]
|Study Start Date:||October 2002|
|Study Completion Date:||May 2008|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
Procedure: External cephalic version with and without spinal anesthesia
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119184
|Hadassah Hebrew University Medical Center|
|Jerusalem, Israel, 12000|
|Principal Investigator:||Carolyn F Weiniger, MB ChB||Dept Anesthesiology, Hadassah Hebrew University Medical School|