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Sponsored by: |
Northwestern University |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00565383 |
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 |
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Pregnancy Breech Presentation |
Procedure: Combined spinal-epidural analgesia (Fentanyl treatment) during the version procedure |
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 |
Enrollment: | 101 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | March 2008 |
Arms | Assigned Interventions |
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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
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Fentanyl: Active Comparator
Fentanyl administered before the version procedure
|
Procedure: Combined spinal-epidural analgesia (Fentanyl treatment) during the version procedure
Combined spinal-epidural
|
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Pregnancy 37 Weeks Gestation Breech Presentation |
Version Procedure Pain Control Neuraxial analgesia |
Fentanyl Pregnancy Complications Obstetric Labor Complications Pain Breech Presentation |