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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00565383
Acronym
Version
Enrollment
101
Registered
2007-11-30
Start date
2002-08-31
Completion date
2006-06-30
Last updated
2013-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Breech Presentation

Keywords

Pregnancy, 37 Weeks Gestation, Breech Presentation, Version Procedure, Pain Control, Neuraxial analgesia

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.

Interventions

Combined spinal-epidural

PROCEDUREIntravenous fentanyl (50mcg)

Intravenous fentanyl

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frame
Does combined spinal-epidural analgesia improve the success rate of external cephalic version?Time between analgesia intervention for the version procedure and delivery

Secondary

MeasureTime frame
Mode of deliveryAt delivery
Maternal satisfactionBetween analgesic intervention and the completion of the version procedure
Maternal PainBetween analgesic intervention and termination of the version procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026