Spinal Anesthesia for External Cephalic Version

Not Applicable

Suspended

• Conditions: Breech Presentation; Before Labor
• Interventions: Procedure: Spinal Anaesthesia

• Registration Number: NCT03797833
• Lead Sponsor: Region Skane

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-01-07
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27
• Primary Completion: 2029-01-31
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal anaesthesia	Spinal Anaesthesia	ECV after low dose spinal anaesthesia (Bupivacain 2,5 mg plus Sufentanil 5 micrograms (µg)

Primary Outcome Measures

Name	Time	Method
External version success rate	1 hour	Rate of successful version as assessed by gynaecologist after maximum three attempts.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Skåne University Hospital; 🇸🇪 Malmö, Sweden