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External Cephalic Version Immediately Before a Caesarean Delivery

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Not yet enrolling

Conditions

Malpresentation Before Labor Affecting Fetus or Newborn

Treatments

Procedure: External cephalic version

Study type

Interventional

Funder types

Other

Identifiers

NCT05020340
UW 21-086

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All women age ≥ 18 years old
  • Singleton pregnancy
  • Malpresentation
  • Have failed an ECV
  • Pregnant ≥ 37 weeks of gestation

Exclusion criteria

  • Condition requiring emergency delivery
  • Other indication for Caesarean section
  • History of antepartum haemorrhage in the past 7 days
  • Oligohydraminos with amniotic fluid index <5cm
  • Intrauterine growth restriction with abnormal fetal Doppler or cardiotocography
  • Rhesus isoimmunization
  • Rupture of membranes
  • Gross fetal anomaly
  • Major uterine anomaly
  • Contraindication or refusal to regional anaesthesia
  • Spontaneous cephalic version on the day of scheduled Caesarean section

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 2 patient groups

Intervention
Experimental group
Description:
External cephalic version
Treatment:
Procedure: External cephalic version
Control
No Intervention group
Description:
ECV will not be performed.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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