Zj. Penn et al., A MULTICENTER RANDOMIZED CONTROLLED TRIAL COMPARING ELECTIVE AND SELECTIVE CESAREAN-SECTION FOR THE DELIVERY OF THE PRETERM BREECH INFANT, British journal of obstetrics and gynaecology, 103(7), 1996, pp. 684-689
Objective To determine the optimum mode of delivery for women in prete
rm breech labour at a gestational age of 26 to 32 weeks. Design A mult
icentre randomised controlled trial. Setting Twenty-six hospitals in E
ngland, UK. Participants Women with a singleton breech fetus in sponta
neous preterm labour between 26 and 32 completed weeks of gestation, w
ith no clear indication for a caesarean section or vaginal breech deli
very. Intervention Random allocation to either 'intention to delivery
vaginally' or 'intention to deliver by caesarean section'. Main outcom
e measures Perinatal mortality, neonatal morbidity, maternal morbidity
and gestation at delivery. Results The trial was closed after 17 mont
hs because of low recruitment, by which time substantial numbers of wo
men had been in the eligible gestation period. Thirteen women from six
hospitals were recruited. One infant, randomised to and delivered vag
inally, was stillborn. Three fetal presentations were cephalic at deli
very despite a diagnosis of breech presentation at trial entry. No for
mal statistical analysis was performed due to the small numbers. Concl
usions No conclusions about the optimum mode of delivery for women in
preterm labour with a fetus presenting by the breech can be drawn from
this trial. The low accrual rate was due to clinicians' reluctance to
randomise eligible women, reflecting the circumstances and nature of
the trial.