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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnancy, Pain

Intervention / Treatment
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* Drug: Group 2.5
* Drug: Group 5
* Drug: Group 7.5
* Drug: Group 10


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug:Group 2.5<br>Administration of 2.5 mg bupivacaine | Drug: Group 2.5<br>* Administration of bupivacaine 2.5 mg.<br>* Other names: 2.5 mg bupivacaine;|
| Active Comparator: Group 5<br>Administration of 5 mg bupivacaine. | Drug: Group 5<br>* Administration of 5 mg bupivacaine<br>* Other names: 5 mg bupivacaine;|
| Active Comparator: Group 7.5<br>Administration of 7.5mg bupivacaine. | Drug: Group 7.5<br>* Administration of 7.5 mg bupivacaine<br>* Other names: Administration of 7.5 mg bupivacaine.;|
| Active Comparator: Group 10<br>Administration of 10 mg bupivacaine. | Drug: Group 10<br>* Administration of 10mg bupivacaine.<br>* Other names: Administration of 10mg bupivacaine.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of External Cephalic Version | Rates of successful version evaluated among the 4 dose groups. | Completion of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of Delivery |  | To time of delivery | 
| Indication of Cesarean Delivery |  | To time of delivery | 
| Pain Score During the Procedure | pain score during the procedure (Visual Analog Score: VAS=0 no pain -100 worst pain imaginable, scale) | < 20 minutes | 
| Abdominal Relaxation | Obstetrician rating of participants abdominal relaxation (Visual analog score: VAS score= 0 no relaxation- complete relaxation 100) | <20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Version, Pregnancy, Vaginal Delivery, Pain Control, Combined Spinal Epidural