A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version



Status:Recruiting
Conditions:Chronic Pain, Women's Studies
Therapuetic Areas:Musculoskeletal, Reproductive
Healthy:No
Age Range:18 - Any
Updated:2/2/2017
Start Date:May 2011
End Date:June 2017
Contact:Laurie Chalifoux, MD
Email:l-chalifoux@northwestern.edu
Phone:312-472-3585

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A Randomized Controlled Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version

We plan to conduct a prospective, single blinded, randomized clinical trial to assess the
impact of combined spinal-epidural dosing on the success rate of, and patient satisfaction
during, external version for breech fetal position and the incidence of vaginal vs. Cesarean
delivery.

The research aim of this project is to determine the ideal neuraxial dosing strategy to
maximize success of external cephalic version (ECV).

The research questions, does a combined spinal-epidural (CSE) of a higher dose result in
greater success in converting a breech presentation to vertex during external cephalic
version (ECV).

The hypotheses of this project is that CSE at higher dose will result in greater ECV success
than analgesic dosing.

The research significance:Increasing the success and comfort of ECV for fetal
malpresentation may help decrease the cesarean section rate.

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. However, cesarean delivery, the safer option for the baby, is
associated with a higher incidence of maternal complications for both the current and
subsequent pregnancies. External cephalic version (ECV) 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. (Hofmeyr Cochrane Review)
Obstetricians generally perform versions after 36 weeks gestational age with a reportable
success rate of 50-80%, depending on several factors, including patient characteristics.
(Fortunato, Zhang, ACOG 1997 ECV) The most common technique involves external manipulation
of the fetal position preceded by pharmacologic uterine relaxation. Until recently, pain
relief was generally 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.

Two non-randomized studies of neuraxial analgesia compared to systemic analgesia found
improved success of external cephalic version in the neuraxial analgesia groups.(Carlan,
Birnbach) Three randomized trials have conflicting results: 2 demonstrate an increase in
success, one shows no difference. (Dugoff, Schorr, Mancuso) None of these studies have
blinded the obstetrician performing the version. In 2010, Lavoie and colleagues completed a
meta-analysis looking at ECV performed under analgesic and anesthetic neuraxial doses. The
analgesic dose included spinal bupivacaine and epidural dosing. The anesthestic groups gave
higher doses of spinal or epidural bupivacaine. This meta-analysis suggested that those
patients who had received an anesthetic dose of had more successful ECV. All published
studies examining pain outcomes have demonstrated that neuraxial analgesia results in
greater patient comfort during this procedure.

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."

Inclusion Criteria:

- Healthy patients age 18 and older

- Breech presentation

- Singleton gestation .scheduled for ECV desiring CSE.

Exclusion Criteria:

- Refusal

- Contraindication to neuraxial (coagulopathy, anticoagulant use, local infection,
sepsis etc) .Rupture of membranes.

- Drop-out: Patients may choose to drop-out of the study at any time. The physicians
involved in this study may choose to end a patient's involvement in the study at
their discretion.
We found this trial at
1
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Chicago, Illinois 60611
Phone: 312-472-3585
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Chicago, IL
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