NCT03797833

Brief Summary

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

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
51mo left

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jan 2019Jun 2030

First Submitted

Initial submission to the registry

January 7, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

10.1 years

First QC Date

January 7, 2019

Last Update Submit

October 25, 2022

Conditions

Breech Presentation; Before Labor

Keywords

breech presentation, external version, spinal anaesthesia

Outcome Measures

Primary Outcomes (1)

  • External version success rate

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

    1 hour

Secondary Outcomes (3)

  • Overall maternal satisfaction post external version attempt

    1 hour

  • Overall maternal satisfaction post partum

    3 months

  • Caesarian section rate

    1 months

Study Arms (2)

Standard treatment

NO INTERVENTION

ECV according to standard practice.

Spinal anaesthesia

ACTIVE COMPARATOR

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

Procedure: Spinal Anaesthesia

Interventions

Spinal AnaesthesiaPROCEDURE

Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg

Spinal anaesthesia

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unwilling to participate.
  • Unable to understand written and oral Swedish in the absence of interpreter.
  • Contraindications to spinal anaesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Skåne University Hospital

Lund, Sweden

Location

Skåne University Hospital

Malmo, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 25962611BACKGROUND

  • 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.

    PMID: 27131581BACKGROUND

  • 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.

    PMID: 25674710BACKGROUND

  • 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.

    PMID: 28723831BACKGROUND

MeSH Terms

Conditions

Breech Presentation

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Andreas Herbst, MD PhD

    Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 9, 2019

Study Start

January 7, 2019

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

June 30, 2030

Last Updated

October 27, 2022

Record last verified: 2022-10

Locations

SE(2)