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Spinal Anesthesia for External Cephalic Version

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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03797833
Enrollment
200
Registered
2019-01-09
Start date
2019-01-07
Completion date
2030-06-30
Last updated
2022-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breech Presentation; Before Labor

Keywords

breech presentation, external version, spinal anaesthesia

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.

Interventions

PROCEDURESpinal Anaesthesia

Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
External version success rate1 hourRate of successful version as assessed by gynaecologist after maximum three attempts.

Secondary

MeasureTime frameDescription
Overall maternal satisfaction post external version attempt1 hourEvaluation of overall participant satisfaction using an online assessment questionnaire within an hour from the external version attempts.
Overall maternal satisfaction post partum3 monthsEvaluation of overall participant satisfaction using an online assessment questionnaire within 3 months from the external version attempts (within 2 months post partum)
Caesarian section rate1 monthsThe mode of delivery, assessed from the medical charts after delivery.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026