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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Sullivan, Northwestern University
ClinicalTrials.gov Identifier:
NCT00565383
First received: November 29, 2007
Last updated: June 12, 2013
Last verified: June 2013

November 29, 2007
June 12, 2013
August 2002
June 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00565383 on ClinicalTrials.gov Archive Site
  • Mode of delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Maternal satisfaction [ Time Frame: Between analgesic intervention and the completion of the version procedure ] [ Designated as safety issue: No ]
  • Maternal Pain [ Time Frame: Between analgesic intervention and termination of the version procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position
The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pregnancy
  • Breech Presentation
  • Procedure: Combined spinal-epidural analgesia
    Combined spinal-epidural
  • Procedure: Intravenous fentanyl (50mcg)
    Intravenous fentanyl
  • Active Comparator: Intravenous fentanyl analgesia
    Intravenous fentanyl (50 mcg) analgesia
    Intervention: 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
    Intervention: Procedure: Combined spinal-epidural analgesia

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
June 2006
June 2006   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00565383
0897-002, Sullivan 002
No
John Sullivan, Northwestern University
Northwestern University
Not Provided
Principal Investigator: John T Sullivan, M.D. Northwestern University, Feinberg School of Medicine
Northwestern University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP