The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position (Version)
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|ClinicalTrials.gov Identifier: NCT00565383|
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : June 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Breech Presentation||Procedure: Combined spinal-epidural analgesia Procedure: Intravenous fentanyl (50mcg)||Not Applicable|
At term 2 to 3% of singleton pregnancies are in breech presentation. Many of these deliveries are managed by cesarean delivery due to higher neonatal morbidity associated with vaginal breech delivery. Cesarean delivery, the safer option for the baby, however, is associated with a higher incidence of maternal complications for both the current and subsequent pregnancies. External cephalic version is a procedure commonly used to attempt to manually rotate the fetus into vertex position. This facilitates vaginal delivery and thus avoids higher maternal and/or neonatal complications.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
Active Comparator: Intravenous fentanyl analgesia
Intravenous fentanyl (50 mcg) analgesia
Procedure: Intravenous fentanyl (50mcg)
Experimental: Combined spinal-epidural analgesia
Combined spinal-epidural analgesia (intrathecal fentanyl 2.5 mg plus bupivacaine 2.5 mg) single administration
Procedure: Combined spinal-epidural analgesia
- Does combined spinal-epidural analgesia improve the success rate of external cephalic version? [ Time Frame: Time between analgesia intervention for the version procedure and delivery ]
- Mode of delivery [ Time Frame: At delivery ]
- Maternal satisfaction [ Time Frame: Between analgesic intervention and the completion of the version procedure ]
- Maternal Pain [ Time Frame: Between analgesic intervention and termination of the version procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565383
|United States, Illinois|
|Prentice Women's Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||John T Sullivan, M.D.||Northwestern University Feinberg School of Medicine|