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Abstract
BackgroundAdverse events from intrapartum antibiotic prophylaxis (IAP) are poorly documented yet essential to inform clinical practice for neonatal group B Streptococcus (GBS) disease prevention. In this systematic review, we appraised and synthesised the evidence on the adverse events of IAP in the mother and/or her child.MethodsWe searched MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Cochrane, and Science Citation Index from date of inception until October 16th 2016. Reference lists of included studies and relevant systematic reviews were hand-searched. We included primary studies in English that reported any adverse events from intrapartum antibiotics for any prophylactic purpose compared to controls. The search was not restricted to prophylaxis for GBS but excluded women with symptoms of infection or undergoing caesarean section. Two reviewers assessed the methodological quality of studies, using the Cochrane Risk of Bias tool, and the Risk of Bias Assessment Tool for Nonrandomised Studies. Results were synthesised narratively and displayed in text and tables.ResultsFrom 2364 unique records, 30 studies were included. Despite a wide range of adverse events reported in 17 observational studies and 13 randomised controlled trials (RCTs), the evidence was inconsistent and at high risk of bias. Only one RCT investigated the long-term effects of IAP reporting potentially serious outcomes such as cerebral palsy; however, it had limited applicability and unclear biological plausibility. Seven observational studies showed that IAP for maternal GBS colonisation alters the infant microbiome. However, study populations were not followed through to clinical outcomes, therefore clinical significance is unknown. There was also observational evidence for increased antimicrobial resistance, however studies were at high or unclear risk of bias.ConclusionsThe evidence base to determine the frequency of adverse events from intrapartum antibiotic prophylaxis for neonatal GBS disease prevention is limited. As RCTs may not be possible, large, better quality, and longitudinal observational studies across countries with widespread IAP could fill this gap.Trial registrationCRD42016037195.
Highlights
Adverse events from intrapartum antibiotic prophylaxis (IAP) are poorly documented yet essential to inform clinical practice for neonatal group B Streptococcus (GBS) disease prevention
Some IAP effectiveness trials reported outcomes, such as neonatal and maternal infection, that could plausibly increase from IAP due to changes in the organisms causing infections and/or antibiotic susceptibility [18, 44], but could decrease if the IAP is successful [40, 43, 47,48,49,50,51,52,53, 55, 58]
To prevent bias in reporting, we reported these outcomes irrespective of whether they were identified as benefits or harms
Summary
Adverse events from intrapartum antibiotic prophylaxis (IAP) are poorly documented yet essential to inform clinical practice for neonatal group B Streptococcus (GBS) disease prevention. If a pregnant woman is vaginally colonised with GBS when she is in labour, there is a 36% chance that GBS will be transmitted to her neonate [6]. To prevent EOGBS, the currently available prevention is intrapartum antibiotic prophylaxis (IAP), administered to mothers identified at risk of vertically transmitting GBS bacteria [9, 10]. Women are offered IAP if they present with known risk factors for GBS, such as intrapartum fever or GBS bacteriuria, and in many other countries, women are actively screened for GBS colonisation at 35-37 weeks of pregnancy and treated in labour if they are positive [12]. Screening for GBS maternal colonisation is controversial as up to 30% of women with positive results at 35-37 weeks revert to negative by labour [13], and the large majority of women who are colonised with GBS during labour have healthy neonates who will not suffer from EOGBS
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