The Royal College of Obstetricians and Gynaecologists (RCOG) is aware of the findings of the ORACLE Children Study published in the Lancet, funded by the Medical Research Council (MRC).
In response to these new findings, the RCOG reviewed the recommendations of its clinical guidelines, Preterm Prelabour Rupture of Membranes (2006) and Prevention of Early-Onset Neonatal Group B Streptococcal Disease (2003). We confirm that our guidelines do not require any changes following publication of the findings of the ORACLE study.
Preterm prelabour rupture of the membranes (PPROM) refers to the leak of amniotic fluid before 37 weeks gestation. The condition is also commonly referred to as when the ‘waters break’ early. Only around 2% of women experience PPROM. The reason why this happens is unknown.
The membranes which surround the baby provide a protective layer and when these break, sometimes, bacteria enter the uterus, resulting in infection (chorioamnionitis) which precipitates preterm birth. Often, labour commences within 48 hours of PPROM. Doctors and midwives follow clinical protocols to optimise the chances of a safe delivery. This usually includes the administration of antibiotics to reduce the incidence of intrauterine infection. RCOG guidelines recommend the use of erythromycin.
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.
To view the summary of the main results of the ORACLE Children Study sent to women who were involved in the trial, please click here.
To view the joint letter from the Chief Medical Officer, the Chief Nursing Officer and the Chief Pharmaceutical Officer to healthcare professionals on the results of the ORACLE Children Study, please click here.
To view the RCOG Patient Information leaflet When your waters break early (preterm premature rupture of the membranes), please click here.xxxx
For more information on the ORACLE Children Study, please visit www.le.ac.uk/oraclechildren.
To view the ORACLE papers published in the Lancet, please visit http://www.thelancet.com/online/focus/oracle
Kenyon, S, Pike, K, Jones DR, Brocklehurst, P, Marlow, N, Salt, A, Taylor, DJ. (2008) Childhood outcomes following prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the Oracle I trial. Advance online publication, Lancet.
Childhood outcomes following prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the Oracle II trial. Advance online publication, Lancet.