Clinical trial NCT00565383: The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position
Official title: The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Breech Presentation
Keywords: Pregnancy
37 Weeks Gestation
Breech Presentation
Version Procedure
Pain Control
Neuraxial analgesia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2007-11-30
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Does combined spinal-epidural analgesia improve the success rate of external cephalic version?
timeFrame: Time between analgesia intervention for the version procedure and delivery
Secondary outcomes:
measure: Mode of delivery
timeFrame: At delivery
measure: Maternal satisfaction
timeFrame: Between analgesic intervention and the completion of the version procedure
measure: Maternal Pain
timeFrame: Between analgesic intervention and termination of the version procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: John T Sullivan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fortunato SJ, Mercer LJ, Guzick DS. External cephalic version with tocolysis: factors associated with success. Obstet Gynecol. 1988 Jul;72(1):59-62.
citation: Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12.
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.
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.