External Cephalic Version Immediately Before a Caesarean Delivery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malpresentation Before Labor Affecting Fetus or Newborn

Intervention / Treatment
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* Procedure: External cephalic version


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>External cephalic version | Procedure: External cephalic version<br>* 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.<br>|
| No Intervention: Control<br>ECV will not be performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal birth | Vaginal birth | Delivery |