Increased risk of CP after antibiotics for PTL
Clinical Question
Does administration of erythromycin or amoxicillin-clavulanate to women with spontaneous preterm labor and membranes intact reduce functional impairment in there children at 7 years of age?Clinical Question
Bottom Line
Both erythromycin and amoxicillin-clavulanate given to pregnant women with preterm labor(PTL) and membranes intact led to small, but statistically and clinically significant increases in the prevalence of cerebral palsy (CP) in their 7-year old children as compared with placebo. These results suggest avoidance of antibiotics for women in preterm labor without clinically evident infection. (LOE = 1b)Bottom Line
Reference
Kenyon S, Pike K, Jones DR, et al. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet 2008;372:1319-27. [PMID:18804276]Reference
Study Design
Randomized controlled trial (double-blinded)Study Design
Funding
GovernmentFunding
Allocation
ConcealedAllocation
Setting
UncertainSetting
Synopsis
This is a 7-year follow-up report on the UK's ORACLE II study, which was a randomized controlled trial of oral erythromycin, amoxicillin-calvulanate, both, or placebo for women with spontaneous preterm labor, no clinical sign of infection, and membranes intact. Outcomes for 3196/4221 (71%) of the original participant children were available for analysis. Data were collected with a parent-completed postal questionnaire supplemented by telephone interviews and from family doctors. Parents remained unaware of treatment assignment. There were no differences between groups for the principal outcome of any functional impairment at 7 years of age. Children receiving either antibiotic had greater risk of CP compared with placebo. For erythromycin that was 53/1611 (3.3%) vs (27/1562) 1.7% without it (NNTH = 64, 95% CI 37-209) For amoxicillin-clavulanate it was 50/1587 (3.2%) vs. 30/1586 (1.9%) without (NNTH = 74, 95% CI 42-591). Twenty-three children had died, with no differences between groups. The same issue of this journal includes the report 7-year outcomes of the companion study ORACLE I in which women with preterm rupture of membranes and no clinical sign of infection. [1] This latter study showed no differences in outcomes including no difference in risk of CP. [1] Kenyon S, Pike K, Jones DR, et al. Childhood outcomes after prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the ORACLE I trial. Lancet 2008;372:1310-8.Synopsis
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Citation
Barry, Henry, et al., editors. "Increased Risk of CP After Antibiotics for PTL." EE+ POEM Archive, John Wiley & Sons, 2019. Evidence Central, evidence.unboundmedicine.com/evidence/view/infoPOEMs/426027/all/Increased_risk_of_CP_after_antibiotics_for_PTL.
Increased risk of CP after antibiotics for PTL. In: Barry HH, Ebell MHM, Shaughnessy AFA, et al, eds. EE+ POEM Archive. John Wiley & Sons; 2019. https://evidence.unboundmedicine.com/evidence/view/infoPOEMs/426027/all/Increased_risk_of_CP_after_antibiotics_for_PTL. Accessed March 24, 2023.
Increased risk of CP after antibiotics for PTL. (2019). In Barry, H., Ebell, M. H., Shaughnessy, A. F., & Slawson, D. C. (Eds.), EE+ POEM Archive. John Wiley & Sons. https://evidence.unboundmedicine.com/evidence/view/infoPOEMs/426027/all/Increased_risk_of_CP_after_antibiotics_for_PTL
Increased Risk of CP After Antibiotics for PTL [Internet]. In: Barry HH, Ebell MHM, Shaughnessy AFA, Slawson DCD, editors. EE+ POEM Archive. John Wiley & Sons; 2019. [cited 2023 March 24]. Available from: https://evidence.unboundmedicine.com/evidence/view/infoPOEMs/426027/all/Increased_risk_of_CP_after_antibiotics_for_PTL.
* Article titles in AMA citation format should be in sentence-case
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T1 - Increased risk of CP after antibiotics for PTL
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ED - Ebell,Mark H,
ED - Shaughnessy,Allen F,
ED - Slawson,David C,
BT - EE+ POEM Archive
UR - https://evidence.unboundmedicine.com/evidence/view/infoPOEMs/426027/all/Increased_risk_of_CP_after_antibiotics_for_PTL
PB - John Wiley & Sons
DB - Evidence Central
DP - Unbound Medicine
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