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Researchers evaluate effects on children born to mothers who take antibiotics during pregnancy

Wednesday, October 08 2008 | Comments

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What's This? Antibiotics can be detrimental to children whose mothers experience spontaneous preterm labor with intact membranes and no clear evidence of infection, while antibiotics have little effect on the health of children born to mothers who have preterm rupture of membranes and no infection signs, suggest data from 2 studies.

The ORACLE Children Study II investigation presented follow-up data on the health of children (aged 7 years) of 4,221 eligible women who completed the ORACLE II study. In ORACLE II, women in spontaneous preterm labor who had intact membranes and no overt signs of clinical infection received 250 mg of erythromycin, 375 mg of amoxicillin/clavulanate potassium (co-amoxiclav), both, or placebo 4 times daily for 10 days or until birth.

This follow-up investigation used a structured parental questionnaire to assess the health of the mother's 3,196 eligible children. Functional impairment was the presence of any level of functional impairment (severe, moderate, or mild) on the Multi-Attribute Health Status classification system derived from the Health Utilities Index Mark 3.

The odds of any functional impairment in children born to mothers who were given any erythromycin were 18% greater compared with children whose mothers received no erythromycin (95% CI, 1.02-1.37). The proportions of children with any functional impairment were similar among mothers who had received no co-amoxiclav compared with mothers who had received any co-amoxiclav (40.0% and 40.7%, respectively).

In addition, the administration of either co-amoxiclav or erythromycin to women in threatened preterm labor increased the odds of cerebral palsy (erythromycin OR, 1.93; 95% CI, 1.21-3.09; co-amoxiclav OR, 1.69; 95% CI,1.07-2.67), but the overall risk of this condition was low. However, the number of children with cerebral palsy was greater when both antibiotics were given together (n=35) compared with erythromycin alone (n=18), co-amoxiclav alone (n=15), or placebo alone (n=12).

The number needed to harm with erythromycin was 64 (95% CI, 37-209) and with co-amoxiclav was 79 (95% CI, 42-591). Neither antibiotic appeared to affect number of deaths, other medical conditions, behavioral outcomes, or educational achievement.

"Whatever the causal pathway, the findings in our study, together with concerns about the potential increase in neonatal mortality, support the opinion that antibiotics are not advisable in spontaneous preterm labor without clinical signs of infection," the researchers wrote.

In a second, related study, the ORACLE Children Study I, the same authors concluded that prescription of the same antibiotics to 4,148 women with preterm rupture of the membranes and no infection signs seemed to have little effect on the health of their 3,298 children at 7 years of age.

"It is critical that women with evidence of clinical infection are treated with antibiotics, since clinical chorioamnionitis remains an important cause of maternal, fetal, and neonatal death. The results of this study should not lead to fewer women with overt signs of maternal or fetal infection receiving treatment," they noted.

These findings were published online Sept. 18 ahead of print in The Lancet by Kenyon S, et al.

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