The Lancet

Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. S Kenyon, K Pike, D. R Jones, P Brocklehurst, N Marlow, A. Salt, D.J Taylor. The Lancet (2008) 372: 1319-1327.

There is evidence supporting the increase in survival rates of babies born prematurely but with challenging sequelae. This was found to be inversely proportional to the gestational age at delivery. The observation that a large number of preterm labours are linked to confirmed intrauterine infection/inflammation would support treatment with antibiotics.

A prospective randomised control study involving 4500 women with preterm labour and intact membranes was commenced in 2002. The study group were given Erythromycin and/or Co-amoxiclav while the control group had placebo.

The children born to 4221 participants were followed up at 7 years with parent-completion postal questionnaires. A 71% response rate was achieved. The pre-determined primary outcome was any level of functional impairment in the children and secondary outcomes were basically grades of such restrictions.

The results suggest that Erythromycin and/or Co-amoxiclav was/were associated with the likelihood of developing a functional impairment as well as more severe impairments such as cerebral palsy.

It was suggested that the prolonged use of antibiotics was responsible as most (64%) of participants delivered after 37 weeks gestation.

The authors admitted that the results were unexpected but this supports the importance of childhood follow-up of perinatal and neonatal trials and interventions. This paper would certainly alarm pregnant women, and those who have delivered in the 7 years since the publication of an earlier, related paper: ORACLE II. Indeed, the details of this paper were available on-line before the paper version, at the ORACLE website! It would be interesting to know the number of hits by non-medical web-surfers.

What about the pro-active doctor who prescribes a course of antibiotic for a coincidental respiratory tract infection or urinary tract infection, whilst the patient thought she might be ‘tightening’?

We have not heard the last of this, yet.


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