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A multicentre randomised controlled trial comparing elective and selective caesarean section for the delivery of the
1Academic Unit of Obstetrics and Gynaecology, Charing Cross and Westminster Medical School, Chelsea and Westminster Hospital, London, UK.
Objective:
To determine the optimum mode of delivery for women in preterm breech labour at a gestational age of 26 to 32 weeks.
Design:
A multicentre randomised controlled trial.
Setting:
Twenty-six hospitals in England, UK.
Participants:
Women with a singleton breech fetus in spontaneous preterm labour between 26 and 32 completed weeks of gestation, with no clear indication for a caesarean section or vaginal breech delivery.
Intervention:
Random allocation to either "intention to delivery vaginally' or "intention to deliver by caesarean section'.
Main Outcome Measures:
Perinatal mortality, neonatal morbidity, maternal morbidity and gestation at delivery.
Results:
The trial was closed after 17 months because of low recruitment, by which time substantial numbers of women had been in the eligible gestation period. Thirteen women from six hospitals were recruited. One infant, randomised to and delivered vaginally, was stillborn. Three fetal presentations were cephalic at delivery despite a diagnosis of breech presentation at trial entry. No formal statistical analysis was performed due to the small numbers.
Conclusions:
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.