External Cephalic Version Immediately Before a Caesarean Delivery

NCT05020340 | Unknown

• 1 other identifier: UW 21-086
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malpresentation Before Labor Affecting Fetus or Newborn

Outcome Measures

Primary Outcomes (1)

• Vaginal birth

  Vaginal birth

  Delivery

Study Arms (2)

Intervention

EXPERIMENTAL

External cephalic version

Procedure: External cephalic version

Control

NO INTERVENTION

ECV will not be performed.

Interventions

External cephalic version PROCEDURE

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Interventions

Version, Fetal

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 25, 2021
• Study Start: August 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share