Clinical Trial: The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Northwestern University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: November 29, 2007
Date Started: August 2002
Date Completion:
Last Updated: June 12, 2013
Last Verified: June 2013