The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position
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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 during the version procedure 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 |
- 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 ]
- 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)
|
Procedure: Combined spinal-epidural analgesia 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 |
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| United States, Illinois | |
| Prentice Women's Hospital | |
| Chicago, Illinois, United States, 60611 | |
| 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: | October 23, 2012 |
| 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 Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 23, 2013