A randomised trial to evaluate effectiveness of caesarean section in the prevention of hiv vertical transmission

Objectives: A large proportion of mother-to-child HIV transmission (MCI) is thought to occur during labor and delivery: However observational studies show conflicting results regarding the effect of mode of delivery (MOD) upon MCT The international MOD Trial group initiated an international, multicentre. randomised trial to (I) evaluate the effectiveness of elective caesarean section in decreasing MCT (2) determine the impact of MOD on maternal morbidity and HIV progression. Method:To detect a 2-fokJ reduction in transmission risk (123 to (36), 1500 pregnant women will be enrolled, taking into account differences in use of Zidovudine among trial sites and the number of women who will not have the mode of delivery to which they have been randomised. At 36 weeks of amenorrhea (or later) women who have signed informed consent and do not have a clinical indication for a caesarean section delivery are randomised in a 1:1 ratio to either elective caesarean section delivery (to take place at 38 weeks) or vaginal delivery . Women will be assessed at 6 weeks post-partum and at 6 months after delivery (clinical, hematological and imrnunological information). Maternal morbidity will be compared between the 2 groups. Children will be assessed at 6 weeks of age. 12 weeks and every 3 months until 18 months of age. Infant HIV infection status in the 2 groups is the primary endpoint. Trill setting:The MOD Trial is ongoing. It started first in Italy in 1993, followed by France and South Africa in June 1995. Enrollment is beginning in UK, Switzerland, Spain and Sweden. About 250 women have been enrolled to date.