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

Primary Purpose

Pregnancy, Breech Presentation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined spinal-epidural analgesia
Intravenous fentanyl (50mcg)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Pregnancy, 37 Weeks Gestation, Breech Presentation, Version Procedure, Pain Control, Neuraxial analgesia

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Prentice Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous fentanyl analgesia

Combined spinal-epidural analgesia

Arm Description

Intravenous fentanyl (50 mcg) analgesia

Combined spinal-epidural analgesia (intrathecal fentanyl 2.5 mg plus bupivacaine 2.5 mg) single administration

Outcomes

Primary Outcome Measures

Does combined spinal-epidural analgesia improve the success rate of external cephalic version?

Secondary Outcome Measures

Mode of delivery
Maternal satisfaction
Maternal Pain

Full Information

First Posted
November 29, 2007
Last Updated
June 12, 2013
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00565383
Brief Title
The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position
Acronym
Version
Official Title
The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Breech Presentation
Keywords
Pregnancy, 37 Weeks Gestation, Breech Presentation, Version Procedure, Pain Control, Neuraxial analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous fentanyl analgesia
Arm Type
Active Comparator
Arm Description
Intravenous fentanyl (50 mcg) analgesia
Arm Title
Combined spinal-epidural analgesia
Arm Type
Experimental
Arm Description
Combined spinal-epidural analgesia (intrathecal fentanyl 2.5 mg plus bupivacaine 2.5 mg) single administration
Intervention Type
Procedure
Intervention Name(s)
Combined spinal-epidural analgesia
Intervention Description
Combined spinal-epidural
Intervention Type
Procedure
Intervention Name(s)
Intravenous fentanyl (50mcg)
Intervention Description
Intravenous fentanyl
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Mode of delivery
Time Frame
At delivery
Title
Maternal satisfaction
Time Frame
Between analgesic intervention and the completion of the version procedure
Title
Maternal Pain
Time Frame
Between analgesic intervention and termination of the version procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John T Sullivan, M.D.
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prentice Women's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3288930
Citation
Fortunato SJ, Mercer LJ, Guzick DS. External cephalic version with tocolysis: factors associated with success. Obstet Gynecol. 1988 Jul;72(1):59-62.
Results Reference
background
PubMed Identifier
8336883
Citation
Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12.
Results Reference
background
PubMed Identifier
8067558
Citation
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. doi: 10.1213/00000539-199409000-00021.
Results Reference
background
PubMed Identifier
11473871
Citation
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. doi: 10.1097/00000539-200108000-00035.
Results Reference
background

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

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