Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position
This study is ongoing, but not recruiting participants.
Sponsored by: Northwestern University
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00565383
  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 (Fentanyl treatment) during the version procedure

Drug Information available for: Fentanyl Citrate Fentanyl
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position

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
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
CSE: Active Comparator
a combined spinal-epidural analgesia catheter will be inserted before the version procedure
Procedure: Combined spinal-epidural analgesia (Fentanyl treatment) during the version procedure
Combined spinal-epidural
Fentanyl: Active Comparator
Fentanyl administered before the version procedure
Procedure: Combined spinal-epidural analgesia (Fentanyl treatment) during the version procedure
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
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: Northwestern University ( John T. Sullivan, M.D. )
Study ID Numbers: 0897-002, Sullivan 002
Study First Received: November 29, 2007
Last Updated: November 29, 2007
ClinicalTrials.gov Identifier: NCT00565383  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Fentanyl
Pregnancy Complications
Obstetric Labor Complications
Pain
Breech Presentation

ClinicalTrials.gov processed this record on January 15, 2009