Open Access Study protocol

MRC ORACLE Children Study. Long term outcomes following prescription of antibiotics to pregnant women with either spontaneous preterm labour or preterm rupture of the membranes

Sara Kenyon1*, Peter Brocklehurst2, David Jones3, Neil Marlow4, Alison Salt5 and David Taylor1

Author Affiliations

1 Reproductive Sciences Section, University of Leicester, Leicester, LE2 7LX, UK

2 NPEU, Institute of Health Sciences, Old Road, Headington, Oxford, OX3 7LF, UK

3 Department of Health Sciences, University of Leicester, LE2 7LX, UK

4 Child Health, Queens Medical Centre, Nottingham, NG7 2UH, UK

5 Great Ormond Street Hospital for Sick Children, Great Ormond Street, London, WC1N 3JH, UK

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BMC Pregnancy and Childbirth 2008, 8:14  doi:10.1186/1471-2393-8-14

Published: 24 April 2008

Abstract

Background

The Medical Research Council (MRC) ORACLE trial evaluated the use of co-amoxiclav 375 mg and/or erythromycin 250 mg in women presenting with preterm rupture of membranes (PROM) ORACLE I or in spontaneous preterm labour (SPL) ORACLE II using a factorial design. The results showed that for women with a singleton baby with PROM the prescription of erythromycin is associated with improvements in short term neonatal outcomes, although co-amoxiclav is associated with prolongation of pregnancy, a significantly higher rate of neonatal necrotising enterocolitis was found in these babies. Prescription of erythromycin is now established practice for women with PROM. For women with SPL antibiotics demonstrated no improvements in short term neonatal outcomes and are not recommended treatment. There is evidence that both these conditions are associated with subclinical infection so perinatal antibiotic administration may reduce the risk of later disabilities, including cerebral palsy, although the risk may be increased through exposure to inflammatory cytokines, so assessment of longer term functional and educational outcomes is appropriate.

Methods

The MRC ORACLE Children's Study will follow up UK children at age 7 years born to 4809 women with PROM and the 4266 women with SPL enrolled in the earlier ORACLE trials. We will use a parental questionnaire including validated tools to assess disability and behaviour. We will collect the frequency of specific medical conditions: cerebral palsy, epilepsy, respiratory illness including asthma, diabetes, admission to hospital in last year and other diseases, as reported by parents.

National standard test results will be collected to assess educational attainment at Key Stage 1 for children in England.

Discussion

This study is designed to investigate whether or not peripartum antibiotics improve health and disability for children at 7 years of age.

Trial registration

The ORACLE Trial and Children Study is registered in the Current Controlled Trials registry. ISCRTN 52995660