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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565383
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : June 13, 2013
Information provided by (Responsible Party):
John Sullivan, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Pregnancy Breech Presentation Procedure: Combined spinal-epidural analgesia Procedure: Intravenous fentanyl (50mcg) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Intravenous fentanyl analgesia
Intravenous fentanyl (50 mcg) analgesia
Procedure: Intravenous fentanyl (50mcg)
Intravenous fentanyl

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
Combined spinal-epidural

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Mode of delivery [ Time Frame: At delivery ]
  2. Maternal satisfaction [ Time Frame: Between analgesic intervention and the completion of the version procedure ]
  3. Maternal Pain [ Time Frame: Between analgesic intervention and termination of the version procedure ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00565383

United States, Illinois
Prentice Women's Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: John T Sullivan, M.D. Northwestern University Feinberg School of Medicine

Responsible Party: John Sullivan, John T. Sullivan M.D., Northwestern University Identifier: NCT00565383     History of Changes
Other Study ID Numbers: 0897-002
Sullivan 002 ( Other Identifier: NorthwesternU )
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013

Keywords provided by John Sullivan, Northwestern University:
37 Weeks Gestation
Breech Presentation
Version Procedure
Pain Control
Neuraxial analgesia

Additional relevant MeSH terms:
Breech Presentation
Obstetric Labor Complications
Pregnancy Complications
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General