Association between paracetamol use during pregnancy and perinatal outcomes: Prospective NISAMI cohort

BACKGROUND: Paracetamol is widely used to manage fever and pain during pregnancy worldwide. However, paracetamol may affect the pregnant woman and fetus, once this drug crosses the placental barrier after therapeutic doses and may impair fetal liver function, affecting fetus growth and development. Thus, this study aimed to investigate the association between paracetamol use during pregnancy and perinatal outcomes as preterm birth, low birth weight, and small for gestational age. METHODS AND FINDINGS: Data from 760 pregnant women within the NISAMI Cohort between June 2012 and February 2014 were analyzed. Logistic regression was used to estimate the association among paracetamol use during pregnancy and preterm birth, low birth weight, and small for gestational age. Multivariate analyses were adjusted for socioeconomic, maternal, pregnancy, and newborn covariates. Around 14% of women were exposed to paracetamol during pregnancy. A decrease in paracetamol use throughout pregnancy was observed. Lower risk of low birth weight in infants born to women exposed to the drug (OR 0.21; IC 95% 0.01–0.99) was found. Paracetamol use during pregnancy was not statistically associated with preterm birth or small for gestational age. CONCLUSIONS: The findings of this study do not suggest an increased risk of perinatal outcomes. However, it should not be assumed that paracetamol is a risk-free medication and its use must be rational.