Spinal Anesthesia for External Cephalic Version

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03797833
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Information provided by (Responsible Party):
Region Skane

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

Condition or disease Intervention/treatment Phase
Breech Presentation; Before Labor Procedure: Spinal Anaesthesia Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Anesthesia for External Cephalic Version in Nulliparous Women, A Controlled Randomized Study
Estimated Study Start Date : January 7, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
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
Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg

Primary Outcome Measures :
  1. External version success rate [ Time Frame: 1 hour ]
    Rate of successful version as assessed by gynaecologist after maximum three attempts.

Secondary Outcome Measures :
  1. Overall maternal satisfaction post external version attempt [ Time Frame: 1 hour ]
    Evaluation of overall participant satisfaction using an online assessment questionnaire within an hour from the external version attempts.

  2. Overall maternal satisfaction post partum [ Time Frame: 3 months ]
    Evaluation of overall participant satisfaction using an online assessment questionnaire within 3 months from the external version attempts (within 2 months post partum)

  3. Caesarian section rate [ Time Frame: 1 months ]
    The mode of delivery, assessed from the medical charts after delivery.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03797833

Contact: Anna Tranberg Lindqvist, MD +4646172233
Contact: Sofus Rabow, MD +46174222

Skåne University Hospital Recruiting
Lund, Sweden
Contact: Andreas Herbst, MD, PhD    +4646171000   
Contact: Anna Tranberg Lindqvist, MD    +4646172233   
Sub-Investigator: Sofus Rabow, MD         
Skåne University Hospital Recruiting
Malmö, Sweden
Contact: Agusta Waage, MD   
Sponsors and Collaborators
Region Skane
Principal Investigator: Andreas Herbst, MD PhD Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden

Responsible Party: Region Skane Identifier: NCT03797833     History of Changes
Other Study ID Numbers: 2018/634
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Region Skane:
breech presentation, external version, spinal anaesthesia

Additional relevant MeSH terms:
Breech Presentation
Obstetric Labor Complications
Pregnancy Complications
Central Nervous System Depressants
Physiological Effects of Drugs