The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position
NCT ID: NCT00565383
Last Updated: 2013-06-13
Study Results
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Basic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2002-08-31
2006-06-30
Brief Summary
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Detailed Description
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Obstetricians perform versions after 36 weeks gestational age with a reportable success rate of 30-80%. The most common technique involves external manipulation of the fetal position preceded by pharmacologic uterine relaxation. Pain relief is most commonly provided in the form of intravenous opioids such as fentanyl. A more efficacious form of analgesia is the use of neuraxial opioids and local anesthetics (neuraxial analgesia), a technique commonly used for labor and delivery analgesia.
Although the use of neuraxial analgesia and anesthesia techniques improve maternal pain and satisfaction, there is conflicting evidence if they improve the success rate of version procedures. The American College of Obstetricians and Gynecologists (ACOG) has stated, "Currently there is not enough evidence to make a recommendation favoring or opposing anesthesia during ECV (external cephalic version) attempts."
We propose to conduct a prospective, single blinded, randomized clinical trial to assess the impact of combined spinal-epidural analgesia on the success rate of external version for breech fetal position and the subsequent incidence of vaginal vs. Cesarean delivery as a secondary outcome.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intravenous fentanyl analgesia
Intravenous fentanyl (50 mcg) analgesia
Intravenous fentanyl (50mcg)
Intravenous fentanyl
Combined spinal-epidural analgesia
Combined spinal-epidural analgesia (intrathecal fentanyl 2.5 mg plus bupivacaine 2.5 mg) single administration
Combined spinal-epidural analgesia
Combined spinal-epidural
Interventions
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Combined spinal-epidural analgesia
Combined spinal-epidural
Intravenous fentanyl (50mcg)
Intravenous fentanyl
Eligibility Criteria
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Inclusion Criteria
* Female
* Pregnant
* Breech Presentation
* Greater than 36 Weeks gestation
* Version Procedure
Exclusion Criteria
18 Years
55 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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John Sullivan
John T. Sullivan M.D.
Principal Investigators
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John T Sullivan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Northwestern University Feinberg School of Medicine
Locations
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Prentice Women's Hospital
Chicago, Illinois, United States
Countries
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References
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Fortunato SJ, Mercer LJ, Guzick DS. External cephalic version with tocolysis: factors associated with success. Obstet Gynecol. 1988 Jul;72(1):59-62.
Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12.
Carlan SJ, Dent JM, Huckaby T, Whittington EC, Shaefer D. The effect of epidural anesthesia on safety and success of external cephalic version at term. Anesth Analg. 1994 Sep;79(3):525-8. doi: 10.1213/00000539-199409000-00021.
Birnbach DJ, Matut J, Stein DJ, Campagnuolo J, Drimbarean C, Grunebaum A, Kuroda MM, Thys DM. The effect of intrathecal analgesia on the success of external cephalic version. Anesth Analg. 2001 Aug;93(2):410-3, 4th contents page. doi: 10.1097/00000539-200108000-00035.
Other Identifiers
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Sullivan 002
Identifier Type: OTHER
Identifier Source: secondary_id
0897-002
Identifier Type: -
Identifier Source: org_study_id
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