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

Overview

Journal BMC Pregnancy Childbirth

Publisher Biomed Central

Specialty Gynecology & Obstetrics

Date 2008 Apr 26

PMID 18435833

Citations 3

Authors

Sara Kenyon

Peter Brocklehurst

David Jones

Neil Marlow

Alison Salt

David Taylor

Affiliations

Soon will be listed here.

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.

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Prevalence, Spectrum and Antibiotic Susceptibility of Bacterial and Candida Colonization between the 21st and 33rd Week of Gestation in Women with PPROM - 5 Years' Experience in 1 Perinatal Center.

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Antibiotics for preterm rupture of membranes.

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