Tobacco smoking in pregnancy is a worldwide public health problem. A majority of pregnant smokers need assistance to stop smoking. Most scientific societies recommend nicotine replacement therapy (NRT) during pregnancy but this recommendation remains controversial because of the known fetal toxicity of nicotine. The objective of this systematic review was to provide an overview of human studies about child health outcomes associated with NRT use during pregnancy. The electronic databases MEDLINE, the Cochrane Database, Web of Science, and ClinicalTrials.gov were searched from the inception of each database until 26 December 2020. A total of 103 articles were identified through database searching using combination of keywords. Out of 75 screened articles and after removal of duplicates, ten full-text articles were assessed for eligibility and five were included in the qualitative synthesis. NRT prescription seems to be associated with higher risk of infantile colic at 6 months as in case of smoking during pregnancy, and with risk of attention-deficit/hyperactivity disorder. No association between NRT during pregnancy and other infant health disorders or major congenital anomalies has been reported. Well-designed controlled clinical trials with sufficient follows-up are needed to provide more information on the use of NRT or other pharmacotherapies for smoking cessation during pregnancy on post-natal child health outcomes.

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