PERINATAL TRIALS REPORT

PERINATAL TRIALS REPORT

PT0542

Early external cephalic version 2 trial

Plain Language Summary: About 3-4% of babies born at term will be born breech with their bottoms born before their head. Caesarean section (CS) is safest for breech babies but less safe for mothers compared to vaginal births. Babies can be turned before they are born using a procedure called external cephalic version (ECV). In a pilot study we found that starting ECV earlier (at 34-36 weeks) might help to decrease the number of breech babies compared to ECV at the usual time (at 37 weeks or later) but a larger study is needed to evaluate if early ECV decreases CS rates.

Trial status: Open to accrual

Date trial opened to accrual: December 2004

Expected accrual period: 4 years

Trial Objective:

1. Primary: For women with a fetus in breech presentation, does early ECV (at 34 0/7 - 35 6/7 weeks) versus delayed ECV (not before 37 0/7 weeks) increase or decrease the likelihood of CS?

2. Secondary: Is the risk of preterm birth (<37 0/7 weeks) lower or higher with early versus delayed ECV?

3. Other: What is the effect of early versus delayed ECV on:

a) admission to the neonatal intensive care unit for greater or equal to 24 hours?

b) perinatal or neonatal mortality or serious neonatal morbidity?

c) serious fetal complications?

d) maternal death or serious maternal morbidity?

e) non-cephalic presentation at birth?

f) pain experienced during the ECV procedure?

g) women's views regarding the timing and use of ECV as an approach for their care?

h) health care costs?

Type of administration: Multi-centre International

Prinicipal Investigator/s: Dr Eileen Hutton

Ph 604 875 2000 (ext 5356)

Email ehutton@interchange.ubc.ca

Contact Person/s: Ariadna Fernandez

Ph 604 875 2000 (ext 5322)

Email afernandez@cw.bc.ca