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Abstract
Drug exposure during pregnancy lacks global fetal safety data. The maternal drug exposure birth cohort (DEBC) study, a prospective longitudinal investigation, aims to explore the correlation of maternal drug exposure during pregnancy with pregnancy outcomes, and establish a human biospecimen biobank. Here we describe the process of establishing DEBC and show that the drug exposure rate in the first trimester of pregnant women in DEBC (n = 112,986) is 30.70%. Among the drugs used, dydrogesterone and progesterone have the highest exposure rates, which are 11.97% and 10.82%, respectively. The overall incidence of adverse pregnancy outcomes is 13.49%. Dydrogesterone exposure during the first trimester is correlated with higher incidences of stillbirth, preterm birth, low birth weight, and birth defects, along with a lower incidence of miscarriage/abortion. Due to the limitations of this cohort study, causative conclusions cannot be drawn. Further follow-up and in-depth data analysis are planned for future studies.
Drug exposure during pregnancy lacks sufficient fetal safety information world-widely. Here, the authors report the establishment a multi-center birth cohort to explore the correlation of maternal drug exposure during pregnancy with pregnancy outcomes.
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1 Sichuan University, National Center for Birth Defect Monitoring, West China Second University Hospital, Chengdu, China (GRID:grid.13291.38) (ISNI:0000 0001 0807 1581); Ministry of Education, Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Chengdu, China (GRID:grid.419897.a) (ISNI:0000 0004 0369 313X)
2 Sichuan University, National Center for Birth Defect Monitoring, West China Second University Hospital, Chengdu, China (GRID:grid.13291.38) (ISNI:0000 0001 0807 1581)
3 The Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Nanning, China (GRID:grid.410649.e)
4 Fuzhou, Fujian Provincial Maternity and Children’s Hospital, Fujian, China (GRID:grid.410649.e)
5 National Human Genetic Resource Center, National Research Institute for Family Planning, Beijing, China (GRID:grid.453135.5) (ISNI:0000 0004 1769 3691)
6 Ministry of Education, Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Chengdu, China (GRID:grid.419897.a) (ISNI:0000 0004 0369 313X); Sichuan University, Department of Pediatrics, West China Second University Hospital, Chengdu, China (GRID:grid.13291.38) (ISNI:0000 0001 0807 1581)