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
  Purpose

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 Intervention
Pregnancy
Breech Presentation
Procedure: Combined spinal-epidural analgesia
Procedure: Intravenous fentanyl (50mcg)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 101
Study Start Date: August 2002
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00565383

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

Publications:
Responsible Party: John Sullivan, John T. Sullivan M.D., Northwestern University
ClinicalTrials.gov Identifier: NCT00565383     History of Changes
Other Study ID Numbers: 0897-002, Sullivan 002
Study First Received: November 29, 2007
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 15, 2014