Spinal Anesthesia for External Cephalic Version

October 25, 2022 updated by: Region Skane

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

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Skåne University Hospital
      • Malmö, Sweden
        • Skåne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
External version success rate
Time Frame: 1 hour
Rate of successful version as assessed by gynaecologist after maximum three attempts.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour
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 months
Caesarian section rate
Time Frame: 1 months
The mode of delivery, assessed from the medical charts after delivery.
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Andreas Herbst, MD PhD, Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 7, 2019

Primary Completion (ANTICIPATED)

January 31, 2029

Study Completion (ANTICIPATED)

June 30, 2030

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (ACTUAL)

January 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/634

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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