Spinal Anesthesia for External Cephalic Version

Region Skane

Status: Suspended

Conditions: Breech Presentation; Before Labor

Treatments: Procedure: Spinal Anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03797833

2018/634

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Standard treatment

No Intervention group

Description:

ECV according to standard practice.

Spinal anaesthesia

Active Comparator group

Description:

ECV after low dose spinal anaesthesia (Bupivacain 2,5 mg plus Sufentanil 5 micrograms (µg)

Treatment:

Procedure: Spinal Anaesthesia