Does administration of erythromycin or amoxicillin-clavulanate to women with spontaneous preterm labor and membranes intact reduce functional impairment in there children at 7 years of age?

Both erythromycin and amoxicillin-clavulanate given to pregnant women with preterm labor(PTL) and membranes intact led to small, but statistically and clinically significant increases in the prevalence of cerebral palsy (CP) in their 7-year old children as compared with placebo. These results suggest avoidance of antibiotics for women in preterm labor without clinically evident infection. (LOE = 1b)

Kenyon S, Pike K, Jones DR, et al. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet 2008;372:1319-27.  [PMID:18804276]

Randomized controlled trial (double-blinded)

Government

Concealed

Uncertain

This is a 7-year follow-up report on the UK's ORACLE II study, which was a randomized controlled trial of oral erythromycin, amoxicillin-calvulanate, both, or placebo for women with spontaneous preterm labor, no clinical sign of infection, and membranes intact. Outcomes for 3196/4221 (71%) of the original participant children were available for analysis. Data were collected with a parent-completed postal questionnaire supplemented by telephone interviews and from family doctors. Parents remained unaware of treatment assignment. There were no differences between groups for the principal outcome of any functional impairment at 7 years of age. Children receiving either antibiotic had greater risk of CP compared with placebo. For erythromycin that was 53/1611 (3.3%) vs (27/1562) 1.7% without it (NNTH = 64, 95% CI 37-209) For amoxicillin-clavulanate it was 50/1587 (3.2%) vs. 30/1586 (1.9%) without (NNTH = 74, 95% CI 42-591). Twenty-three children had died, with no differences between groups. The same issue of this journal includes the report 7-year outcomes of the companion study ORACLE I in which women with preterm rupture of membranes and no clinical sign of infection. [1] This latter study showed no differences in outcomes including no difference in risk of CP. [1] Kenyon S, Pike K, Jones DR, et al. Childhood outcomes after prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the ORACLE I trial. Lancet 2008;372:1310-8.