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Spinal Anesthesia for External Cephalic Version

Primary Purpose

Breech Presentation; Before Labor

Status

Suspended

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Spinal Anaesthesia

About this trial

This is an interventional treatment trial for Breech Presentation; Before Labor focused on measuring breech presentation, external version, spinal anaesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Skåne University Hospital
Skåne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard treatment

Spinal anaesthesia

Arm Description

ECV according to standard practice.

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

Outcomes

Primary Outcome Measures

External version success rate

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

Secondary Outcome Measures

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.

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)

Caesarian section rate

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

Full Information

NCT ID

NCT03797833

First Posted

January 7, 2019

Last Updated

October 25, 2022

Sponsor

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT03797833

Brief Title

Spinal Anesthesia for External Cephalic Version

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Suspended

Why Stopped

Slow inclusion rate. Central contact person quit for another job.

Study Start Date

January 7, 2019 (Actual)

Primary Completion Date

January 31, 2029 (Anticipated)

Study Completion Date

June 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breech Presentation; Before Labor

Keywords

breech presentation, external version, spinal anaesthesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard treatment

Arm Type

No Intervention

Arm Description

ECV according to standard practice.

Arm Title

Spinal anaesthesia

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Spinal Anaesthesia

Intervention Description

Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg

Primary Outcome Measure Information:

Title

External version success rate

Description

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

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Overall maternal satisfaction post external version attempt

Description

Evaluation of overall participant satisfaction using an online assessment questionnaire within an hour from the external version attempts.

Time Frame

1 hour

Title

Overall maternal satisfaction post partum

Description

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

Title

Caesarian section rate

Description

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

Time Frame

1 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Herbst, MD PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Skåne University Hospital

City

Lund

Country

Sweden

Facility Name

Skåne University Hospital

City

Malmö

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25962611

Citation

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.

Results Reference

background

PubMed Identifier

27131581

Citation

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.

Results Reference

background

PubMed Identifier

25674710

Citation

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.

Results Reference

background

PubMed Identifier

28723831

Citation

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.

Results Reference

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Spinal Anesthesia for External Cephalic Version

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