CClinicalTrials.gg
Not yet recruitingNCT05020340Updated Aug 25, 2021

External Cephalic Version Immediately Before a Caesarean Delivery

An interventional study of External cephalic version in Malpresentation Before Labor Affecting Fetus or Newborn, sponsored by The University of Hong Kong. Not yet recruiting. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-08-25.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Malpresentation Before Labor Affecting Fetus or Newborn
03

In context

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Intervention

    External cephalic version

    Procedure: External cephalic version

  • No intervention
    Control

    ECV will not be performed.

Interventions

  • ProcedureExternal 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.

06

What researchers measure

Primary outcomes

  1. Vaginal birth

    Vaginal birth

    Time frame: Delivery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05020340
Lead sponsor
The University of Hong Kong
Responsible party
Sponsor
First posted
Aug 25, 2021
Start date
Aug 2021 (estimated)
Primary completion
Jul 2024 (estimated)
Completion
Jul 2025 (estimated)
Last update
Aug 25, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion