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SuspendedNCT03797833Updated Oct 27, 2022

Spinal Anesthesia for External Cephalic Version

An interventional study of Spinal Anaesthesia in Breech Presentation; Before Labor, sponsored by Region Skane. Suspended at 2 sites in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-27.

Sponsored by Region Skane · Not applicable, Interventional, and Treatment

Why this study was suspended
Slow inclusion rate. Central contact person quit for another job.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Breech Presentation; Before Labor

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Keywords

  • breech presentation, external version, spinal anaesthesia
03

In context

Breech Presentation

41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.

This study's planned enrollment of 200 is above the median of 119 across 31 interventional studies indexed under Breech Presentation.

Browse Breech Presentation studies →

Lead sponsor

Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant nulliparous women.
  • Breech presentation of fetus, eligible for external version.

Exclusion criteria

Exclusion Criteria:

  • Unwilling to participate.
  • Unable to understand written and oral Swedish in the absence of interpreter.
  • to spinal anaesthesia.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • No intervention
    Standard treatment

    ECV according to standard practice.

  • Active comparator
    Spinal anaesthesia

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

    Procedure: Spinal Anaesthesia

Interventions

  • ProcedureSpinal Anaesthesia

    Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg

06

What researchers measure

Primary outcomes

  1. External version success rate

    Rate of successful version as assessed by gynaecologist after maximum three attempts.

    Time frame: 1 hour

Secondary outcomes

  1. 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.

    Time frame: 1 hour

  2. 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)

    Time frame: 3 months

  3. Caesarian section rate

    The mode of delivery, assessed from the medical charts after delivery.

    Time frame: 1 months

07

Study locations

2 sites
  • Skåne University Hospital
    Lund, Sweden
  • Skåne University Hospital
    Malmö, Sweden
08

References and documents

Publications

  • Khaw KS, Lee SW, Ngan Kee WD, Law LW, Lau TK, Ng FF, Leung TY. Randomized trial of anaesthetic interventions in external cephalic version for breech presentation. Br J Anaesth. 2015 Jun;114(6):944-50. doi: 10.1093/bja/aev107. Epub 2015 May 10. PubMed 25962611 ↗
  • Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27. Erratum In: Am J Obstet Gynecol. 2017 Mar;216(3):315. doi: 10.1016/j.ajog.2016.11.1045. PubMed 27131581 ↗
  • Cluver C, Gyte GM, Sinclair M, Dowswell T, Hofmeyr GJ. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version. Cochrane Database Syst Rev. 2015 Feb 9;2015(2):CD000184. doi: 10.1002/14651858.CD000184.pub4. PubMed 25674710 ↗
  • Chalifoux LA, Bauchat JR, Higgins N, Toledo P, Peralta FM, Farrer J, Gerber SE, McCarthy RJ, Sullivan JT. Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial. Anesthesiology. 2017 Oct;127(4):625-632. doi: 10.1097/ALN.0000000000001796. PubMed 28723831 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2019 (actual). Primary completion is estimated for Jan 2029, 120 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2019
First posted
Jan 9, 2019
StartActual
Jan 7, 2019
Primary completionEst.
Jan 31, 2029
CompletionEst.
Jun 30, 2030
Last update
Oct 27, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03797833
Lead sponsor
Region Skane
Responsible party
Sponsor
First posted
Jan 9, 2019
Start date
Jan 7, 2019
Primary completion
Jan 31, 2029 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Oct 27, 2022

Study contacts

Andreas Herbst, MD PhD
principal investigator · Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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