Infection Clinical Trial
Official title:
Associations Between Macrolide Antibiotics Prescribed During Pregnancy and Adverse Child Outcomes
Over the last 20 years, concerns have been raised about rare but serious adverse outcomes
associated with macrolide use during pregnancy. The strongest evidence comes from a large
randomised controlled trial (RCT, ORACLE Child Study II) of women with spontaneous preterm
labour (SPL), which reported an increased risk of cerebral palsy in children whose mothers
received erythromycin compared with no erythromycin. A recent systematic review on macrolides
prescription during pregnancy showed consistent associations with miscarriage, and less
consistent associations with adverse child outcomes such as congenital malformations,
cerebral palsy and epilepsy. In this study, the investigators will evaluate associations
between macrolide antibiotics prescription during pregnancy and a range of adverse child
outcomes.
The investigators compare children whose mothers were prescribed an only monotherapy of
macrolides or penicillins during pregnancy (from 5 gestational week (GW) to delivery and by
trimesters). The investigators estimate the risk ratios of major malformation (overall and
five system-specific) and hazard ratios of four neurodevelopmental disorders (cerebral palsy,
epilepsy, attention-deficit/hyperactivity disorder, and autism spectrum disorder) with
control for potential confounders. The associations will also be examined by subtype of
macrolides and treatment duration.
Mother-child pairs will be analysed in a cohort selected from the UK Clinical Practice
Research Database (CPRD) between 1990 and 2016.
n/a
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