A randomised trial of mode of delivery in women infected with the human immunodeficiency virus

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Abstract
Objective During the pilot phase of a trial to evaluate the effectiveness of caesarean section delivery compared with vaginal delivery in reducing mother‐to‐child transmission of human immunodeficiency virus (HIV) infection, the feasibility of randomisation to mode of delivery was assessed.Design At 36 weeks of pregnancy, women infected with HIV were randomly allocated to either caesarean section delivery at 38 weeks or vaginal delivery. Information was also collected on the reasons why women were not enrolled, either because they refused or had a contraindication.Setting Fifty‐one centres in six European countries. Population Pregnant women with confirmed HIV1 infection Main outcome measures Randomisation.Results Three‐hundred and thirty‐nine women had been randomised by the end of 1996, the large majority from Italy (n= 250) and France (n= 54), with 22 from South Africa, three from Sweden, nine from Barcelona and one from London. A further 150 women were eligible but had not been randomised. Forty‐eight women (14%) were not delivered according to the arm to which they were randomised; the majority (n= 44) were changed from vaginal to caesarean section delivery. There is wide variation between European countries in the acceptability and adherence to the mode of delivery trial.Conclusion The pilot phase of this trial has shown that in some settings randomisation to mode of delivery is feasible and acceptable, but that in other setttings clinicians and pregnant women are more reluctant to be randomised. Pending further information on transmission rates and accrual, enrollment into the trial continues.