Spinal Anesthesia for External Cephalic Version

Breech Presentation; Before Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03797833
• Other study ID #: 2018/634
• Status: Suspended
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: June 30, 2030

Study information

• Verified date: October 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: June 30, 2030
• Est. primary completion date: January 31, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breech Presentation
• Breech Presentation; Before Labor

Intervention

Procedure:
• Spinal Anaesthesia
Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund
Sweden	Skåne University Hospital	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View 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;(2):CD000184. doi: 10.1002/14651858.CD000184.pub4. Review. — View 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. — View 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. Review. Erratum in: Am J Obstet Gynecol. 2017 Mar;216(3):315. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	External version success rate	Rate of successful version as assessed by gynaecologist after maximum three attempts.	1 hour
Secondary	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.	1 hour
Secondary	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)	3 months
Secondary	Caesarian section rate	The mode of delivery, assessed from the medical charts after delivery.	1 months