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| |  Antibiotic Use in Pregnant Women Increases Risk of Functional Impairment in Their Children NEW YORK -- September 17, 2008 -- Long-term follow-up data on a trial to assess the effects of antibiotics given to pregnant women experiencing premature labour, with intact membranes and no obvious infection, has revealed an unexpected increased risk of functional impairment and/or cerebral palsy in some children. This is among the conclusions of the Overview of the Role of Antibiotics in Curtailing Labour and Early Delivery (ORACLE) Children's Study, published early online in 2 articles and in an upcoming edition of The Lancet. Both studies are authored by Sara Kenyon, MD, University of Leicester, Leicester, United Kingdom, and colleagues from the ORACLE study group. The ORACLE Children Study I and II were carried out in the UK to discover whether erythromycin and co-amoxiclav had any long-term effects on the children at 7 years of age born to these mothers. The ORACLE Children Study II looked at mothers in spontaneous premature labour with intact membranes surrounding their unborn child and no obvious sign of infection. The children were born to the 4,221 women who had completed the study, and were followed-up after 7 years using a structured parental questionnaire to assess the child's health status. Data for 3,196 (71%) of eligible children was available. The researchers found that functional impairment was increased in children of mothers who received erythromycin (42.3%, 658 children) compared with no erythromycin (38.3%, 574 children) -- an increase in relative risk of 18% for receiving erythromycin. Co-amoxiclav (with or without erythromycin) had no effect of the proportion of children with any functional impairment. The researchers also made the unexpected discovery that more children whose mothers had received the antibiotics developed cerebral palsy than those who did not. For mothers receiving erythromycin (with or without co-amoxiclav), 53 (3.3%) children had cerebral palsy compared with 27 (1.7%) receiving no erythromycin. For mothers given co-amoxiclav (with or without erythromycin), 50 (3.2%) children had cerebral palsy versus 30 (1.9%) receiving no co-amoxiclav. The risk was clearest for mothers given both antibiotics: 35 (4.4%) of children had cerebral palsy compared with 12 (1.6%) of mothers receiving double placebo. "The prescription of erythromycin for women in spontaneous preterm labour with intact membranes was associated with an increase in functional impairment among their children at 7 years of age. The risk of cerebral palsy was increased by either antibiotic, although the overall risk of this condition was low," the authors concluded. The ORACLE Children Study I followed up 4,148 eligible children whose mothers joined the trial with preterm rupture of the membranes without obvious signs of infection. The original trial reported that prescription of erythromycin to these women resulted in reductions in short-term neonatal morbidity and erythromycin is now recommended treatment. The Children Study, which assessed data from 3,298 (75%) eligible children, found no differences in functional impairment with either antibiotic, and no differences in behavioural difficulties, medical conditions, or educational achievement. In relation to this part of the study, the authors said that "the prescription of antibiotics for women with preterm rupture of the membranes seems to have little effect on the health of children at 7 years of age." In an accompanying comment, Philip J. Steer, Chelsea and Westminster Hospital, London, United Kingdom, and Alison Bedford Russell, Warwick Medical School, Coventry, and Heart of England NHS Trust, Birmingham, United Kingdom said: "The lessons to be learned seem clear; contrary to popular opinion, antibiotics are not risk-free. There are good reasons not to give them in association with threatened preterm labour unless there is clear evidence of infection. It is vital the practice is not extended by stealth beyond that which is justified by the evidence, and interventions given in pregnancy should always be evaluated with proper long-term follow-up."
SOURCE: The Lancet
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