Malpresentation Before Labor Affecting Fetus or Newborn
Conditions
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.
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.
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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal birth | Delivery | Vaginal birth |
Outcome results
None listed