Clinical trial NCT03797833: Spinal Anesthesia for External Cephalic Version
Official title: Spinal Anesthesia for External Cephalic Version in Nulliparous Women, A Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Breech Presentation; Before Labor
Keywords: breech presentation, external version, spinal anaesthesia
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: External version success rate
timeFrame: 1 hour
Secondary outcomes:
measure: Overall maternal satisfaction post external version attempt
timeFrame: 1 hour
measure: Overall maternal satisfaction post partum
timeFrame: 3 months
measure: Caesarian section rate
timeFrame: 1 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden
name: Andreas Herbst, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.