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


METHODS
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.


METHODS
Fifty-one centres in six European countries.


METHODS
Pregnant women with confirmed HIV-1 infection.


METHODS
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.


CONCLUSIONS
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 settings clinicians and pregnant women are more reluctant to be randomised. Pending further information on transmission rates and accrual, enrollment into the trial continues.
Newell
M L
ML
Institute of Child Health, London, UK.
Parazzini
F
F
Mandelbrot
L
L
Peckham
C
C
Semprini
A
A
Bazin
B
B
Darbyshire
J
J
Sanchez
E
E
Pardi
G
G
D002585:Cesarean Section / Q000706:statistics & numerical data; D036861:Delivery, Obstetric / Q000706:statistics & numerical data*; D005060:Europe; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D015497:HIV-1; D006801:Humans; D018445:Infectious Disease Transmission, Vertical; D017060:Patient Satisfaction; D010865:Pilot Projects; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*