Spinal Anesthesia for External Cephalic Version

Study Overview
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Brief Summary
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This study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers scheduled for external version of babies in breech position.

Detailed Description
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Fetuses in breech position are almost always delivered by Caesarian section (CS). If the fetus is in breech position by the end of pregnancy, attempts for external cephalic version (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in multiparous women. There are studies showing a higher rate of successful ECV's if the mother received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with SA. These studies, however, did not take parity into account. The primary aim of this study is to see if SA can increase the rate of successful ECV's in nulliparous women. The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS is decreasing using SA during ECV.

Official Title
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Spinal Anesthesia for External Cephalic Version in Nulliparous Women, A Controlled Randomized Study

Conditions
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Breech Presentation; Before Labor

Intervention / Treatment
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* Procedure: Spinal Anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant nulliparous women. Breech presentation of fetus, eligible for external version. Exclusion Criteria: Unwilling to participate. Unable to understand written and oral Swedish in the absence of interpreter. Contraindications to spinal anaesthesia.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard treatment<br>ECV according to standard practice. | |
| Active Comparator: Spinal anaesthesia<br>ECV after low dose spinal anaesthesia (Bupivacain 2,5 mg plus Sufentanil 5 micrograms (µg) | Procedure: Spinal Anaesthesia<br>* Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| External version success rate | Rate of successful version as assessed by gynaecologist after maximum three attempts. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall maternal satisfaction post external version attempt | Evaluation of overall participant satisfaction using an online assessment questionnaire within an hour from the external version attempts. | 1 hour | 
| Overall maternal satisfaction post partum | Evaluation of overall participant satisfaction using an online assessment questionnaire within 3 months from the external version attempts (within 2 months post partum) | 3 months | 
| Caesarian section rate | The mode of delivery, assessed from the medical charts after delivery. | 1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breech presentation, external version, spinal anaesthesia