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Sponsored by: |
Hadassah Medical Organization |
---|---|
Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00119184 |
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.
Condition | Intervention | Phase |
---|---|---|
Breech Presentation |
Procedure: External cephalic version with and without spinal anesthesia |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 140 |
Study Start Date: | October 2002 |
Study Completion Date: | May 2008 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Hadassah Hebrew University Medical Center | |
Jerusalem, Israel, 12000 |
Principal Investigator: | Carolyn F Weiniger, MB ChB | Dept Anesthesiology, Hadassah Hebrew University Medical School |
Responsible Party: | Hadassah HMO ( Dr Carolyn Weiniger ) |
Study ID Numbers: | 20-25/01/02-HMO-CTIL |
Study First Received: | July 3, 2005 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00119184 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
anesthesia breech external cephalic version |
spinal success anesthesia,spinal |
Pregnancy Complications Obstetric Labor Complications Bupivacaine Breech Presentation |