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

Overview

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.

Full Title of Study: “The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2006

Detailed Description

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.

Interventions

  • Procedure: Combined spinal-epidural analgesia
    • Combined spinal-epidural
  • Procedure: Intravenous fentanyl (50mcg)
    • Intravenous fentanyl

Arms, Groups and Cohorts

  • Active Comparator: Intravenous fentanyl analgesia
    • Intravenous fentanyl (50 mcg) analgesia
  • Experimental: Combined spinal-epidural analgesia
    • Combined spinal-epidural analgesia (intrathecal fentanyl 2.5 mg plus bupivacaine 2.5 mg) single administration

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • 18-55 years of age
  • Female
  • Pregnant
  • Breech Presentation
  • Greater than 36 Weeks gestation
  • Version Procedure

Exclusion Criteria

  • Under 18 or over 55 years of age

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Provider of Information About this Clinical Study
    • Principal Investigator: John Sullivan, John T. Sullivan M.D. – Northwestern University
  • Overall Official(s)
    • John T Sullivan, M.D., Principal Investigator, Northwestern University Feinberg School of Medicine

References

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. Review.

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.

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.

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