NCT05020340

External Cephalic Version Immediately Before a Caesarean Delivery

Reattempt of External Cephalic Version After Regional Anaesthesia Immediately Before a Caesarean Delivery - a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Fetal malpresentation at term affects around 5% of pregnancy and breech presentation is the most common type of malpresentation. It is a common indication for a Caesarean delivery. External cephalic version (ECV) refers to turning the fetus manually and aims to increase the success of vaginal birth by reducing the need for Caesarean section.

Detailed description

Several factors affect the chance of a successful ECV which include multiparity, use of tocolytic and regional anaesthesia during the procedure. Anticipating or not tolerating a painful procedure is another factor that affects the willingness to and success of ECV. ECV can be reattempted under regional anaesthesia immediately just before the Caesarean section to increase the vaginal birth rate in women who have failed an ECV. Therefore, the aim of this study is to evaluate whether this approach could increase the rate of vaginal birth and reduce the non-cephalic presentation at labour and Caesarean section rate.

Conditions

• Malpresentation Before Labor Affecting Fetus or Newborn

Interventions

Type	Name	Description
PROCEDURE	External cephalic version	In the intervention group, ECV will be performed by two operators with one of them having experience of ≥ 5 successful ECV. The procedure will be performed by the first operator under real time continuous ultrasonographic guidance. The fetal head and buttock will be grasped by both hands and attempt to rotate the fetus to a longitudinal lie either in a clockwise or anti-clockwise fashion. The second operator will perform the ECV if the first operator fails the procedure.

Timeline

• Start date: 2021-08-01
• Primary completion: 2024-07-01
• Completion: 2025-07-01
• First posted: 2021-08-25
• Last updated: 2021-08-25