Nick Raine-Fenning
Course Director
Joined: 27 May 2006
Posts: 2037
Location: Nottingham
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 Posted: Fri Sep 19, 2008 4:34 pm Post subject: Results of the ORACLE Children Study (Lancet, Sep 2008) |
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The ORACLE Children Study published in the Lancet and funded by the Medical Research Council (MRC) showed:
| MRC wrote: | The follow-up of the children in the ORACLE Trial has confirmed that antibiotics should not be considered in cases of premature labour where the mother’s waters have not broken and there are no obvious signs of infection. At seven years, the study shows there are increased risks of functional impairment and cerebral palsy in these children, although the original trial had found no benefit or harm upon discharge from hospital.
The ORACLE Trial was the largest trial worldwide into premature labour and was set up to investigate whether giving antibiotics – which might tackle an underlying symptomless infection - to women presenting with signs of premature labour would improve outcomes for babies. The trial recruited two groups of women: those whose waters had broken, and those who showed signs of going into premature labour whose waters had not broken. |
The RCOG then produced this statement:
| RCOG wrote: | The ORACLE trial has shown that the babies of women who had PPROM and received erythromycin had an improved outcome compared to those who did not have PPROM, including increasing the time to delivery, reduction of infection and improved respiratory function.
The ORACLE Children Study however revealed that these early improved outcomes do not make a substantial difference to the children’s health and development long-term.
However, in those women who did not have PPROM, the study suggested that there may be a small increased risk of functional impairment and cerebral palsy in the children of women who took antibiotics because of early premature labour.
These findings do not mean that antibiotics are unsafe for use in pregnancy. Pregnant women showing signs of infection should be treated promptly with antibiotics. The 2007 CEMACH report Saving Mothers' Lives highlights genital tract sepsis as a direct cause of maternal death and untreated infections pose serious risks to both mother and baby. Antibiotics should also therefore be used if there are indications for the prevention of maternal or neonatal infection. |
... so there you go! |
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