External Cephalic Version Immediately Before a Caesarean Delivery

August 18, 2021 updated by: The University of Hong Kong

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
External cephalic version
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.
No Intervention: Control
ECV will not be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal birth
Time Frame: Delivery
Vaginal birth
Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 18, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • UW 21-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malpresentation Before Labor Affecting Fetus or Newborn

Clinical Trials on External cephalic version

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe