An interventional study of Combined spinal-epidural analgesia and Intravenous fentanyl (50mcg) in Pregnancy and Breech Presentation, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-06-13.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
We aim to answer the clinical question: Does combined spinal-epidural analgesia improve the success rate of external cephalic version? We hypothesize that neuraxial analgesia (spinal or epidural analgesia) during version for breech presentation increases successful fetal rotation and decreases the incidence of Cesarean delivery for malpresentation.
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.
Exclusion Criteria:
Intravenous fentanyl (50 mcg) analgesia
Procedure: Intravenous fentanyl (50mcg)
Combined spinal-epidural analgesia (intrathecal fentanyl 2.5 mg plus bupivacaine 2.5 mg) single administration
Procedure: Combined spinal-epidural analgesia
Combined spinal-epidural
Intravenous fentanyl
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
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Northwestern University