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

Study Overview
=================
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.

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

Conditions
-----------------
Pregnancy, Breech Presentation

Intervention / Treatment
-----------------
* Procedure: Combined spinal-epidural analgesia
* Procedure: Intravenous fentanyl (50mcg)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous fentanyl analgesia<br>Intravenous fentanyl (50 mcg) analgesia | Procedure: Intravenous fentanyl (50mcg)<br>* Intravenous fentanyl<br>|
| Experimental: Combined spinal-epidural analgesia<br>Combined spinal-epidural analgesia (intrathecal fentanyl 2.5 mg plus bupivacaine 2.5 mg) single administration | Procedure: Combined spinal-epidural analgesia<br>* Combined spinal-epidural<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery |  | At delivery | 
| Maternal satisfaction |  | Between analgesic intervention and the completion of the version procedure | 
| Maternal Pain |  | Between analgesic intervention and termination of the version procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, 37 Weeks Gestation, Breech Presentation, Version Procedure, Pain Control, Neuraxial analgesia