A survey of studies investigating the association between medication exposure during pregnancy and birth defects_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Jing ^1,2,3 , LI Mingxi ^1,2,3 , LIU Chunrong ^1,2,3 , XIONG Yiquan ^1,2,3 , QI Yana ^1,2,3 ,  TAN Jing ^1,2,3 ,  SUN Xin ^1,2,3

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu 610041, P. R. China;
3. Sichuan Center of Technology Innovation for Real World Data, Chengdu 610041, P. R. China;

Corresponding author：

TAN Jing, Email: tanjing84@outlook.com; SUN Xin, Email: sunxin@wchscu.cn

Keywords：

Pregnant women; Medicine; Birth defect; Observational study; Methodology

DOI：

10.7507/1672-2531.202203015

Video：

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Objective To investigate the methodological characteristics of observational studies on the correlation between drug exposure during pregnancy and birth defects. Methods The PubMed database was searched from January 1, 2020 to December 31, 2020 to identify observational studies investigating the correlation between drug use during pregnancy and birth defects. Literature screening and data extraction were conducted by two researchers and statistical analysis was performed using R 3.6.1 software. Results A total of 40 relevant articles were identified, of which 8 (20.0%) were published in the four major medical journals and their sub-journals, 21 (42.5%) were conducted in Europe and the United States, and 4 were conducted (10.0%) in China. Cohort studies (30, 75.0%) and case-control studies (10, 25%) were the most commonly used study designs. Sixteen studies (40.0%) did not specify how the databases were linked. Sixteen studies (40.0%) did not report a clear definition of exposure, while 17 studies (42.5%) defined exposure as prescribing a drug that could not be guaranteed to have been taken by the pregnant women, possibly resulting in misclassification bias. Six studies (15.0%) did not report the diagnostic criteria for birth defects and 18 studies (45.0%) did not report the types of birth defects. In addition, 33 studies (82.5%) did not control for confounding factors in the study design, while only 19 studies (47.5%) considered live birth bias. Conclusion Improvements are imperative in reporting and conducting observational studies on the correlation between drug use during pregnancy and birth defects. This includes the methods for linking data sources, definition of exposure and outcomes, and control of confounding factors. Methodological criteria are needed to improve the quality of these studies to provide higher quality evidence for policymakers and researchers.

Citation： WANG Jing, LI Mingxi, LIU Chunrong, XIONG Yiquan, QI Yana, TAN Jing, SUN Xin. A survey of studies investigating the association between medication exposure during pregnancy and birth defects. Chinese Journal of Evidence-Based Medicine, 2022, 22(6): 692-705. doi: 10.7507/1672-2531.202203015 Copy

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2.	Wilmer E, Chai S, Kroumpouzos G. Drug safety: pregnancy rating classifications and controversies. Clin Dermatol, 2016, 34(3): 401-409.
3.	谭婧, 彭晓霞, 舒啸尘, 等. 患者登记数据库构建技术规范. 中国循证医学杂志, 2019, 19(7): 771-778.
4.	孙鑫, 张俊华, 王雯, 等. 制定中国中成药真实世界研究技术指导原则, 促进中成药临床研究向决策证据转化. 中国循证医学杂志, 2020, 20(9): 993-999.
5.	Huybrechts KF, Bateman BT, Hernández-Díaz S. Use of real-world evidence from healthcare utilization data to evaluate drug safety during pregnancy. Pharmacoepidemiol Drug Saf, 2019, 28(7): 906-922.
6.	Huybrechts KF, Hernández-Díaz S, Straub L, et al. Association of maternal first-trimester ondansetron use with cardiac malformations and oral clefts in offspring. JAMA, 2018, 320(23): 2429-2437.
7.	Lemon LS, Bodnar LM, Garrard W, et al. Ondansetron use in the first trimester of pregnancy and the risk of neonatal ventricular septal defect. Int J Epidemiol, 2020, 49(2): 648-656.
8.	Benchimol EI, Smeeth L, Guttmann A, et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med, 2015, 12(10): e1001885.
9.	Vandenbroucke JP, von Elm E, Altman DG, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Ann Intern Med, 2007, 147(8): W163-194.
10.	Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ, 2018, 363: k3532.
11.	Mendonca VJ. Maternal folic acid intake and risk of nonsyndromic orofacial clefts: a hospital-based case-control study in Bangalore, India. Cleft Palate Craniofac J, 2020, 57(6): 678-686.
12.	Gildestad T, Bjørge T, Haaland ØA, et al. Maternal use of folic acid and multivitamin supplements and infant risk of birth defects in Norway, 1999-2013. Br J Nutr, 2020, 124(3): 316-329.
13.	Zhang R, Guo L, Zhao D, et al. Maternal B-vitamin intake and B-vitamin supplementation during pregnancy in relation to neonatal congenital heart defects: a case-control study with propensity score matching. Eur J Clin Nutr, 2021, 75(5): 782-791.
14.	Yang J, Kang Y, Cheng Y, et al. Iron intake and iron status during pregnancy and risk of congenital heart defects: a case-control study. Int J Cardiol, 2020, 301: 74-79.
15.	Qu Y, Lin S, Zhuang J, et al. First-trimester maternal folic acid supplementation reduced risks of severe and most congenital heart diseases in offspring: a large case-control study. J Am Heart Assoc, 2020, 9(13): e015652.
16.	Collins RT, Yang W, Carmichael SL, et al. Maternal dietary fat intake and the risk of congenital heart defects in offspring. Pediatr Res, 2020, 88(5): 804-809.
17.	Pauliat E, Onken M, Weber-Schoendorfer C, et al. Pregnancy outcome following first-trimester exposure to fingolimod: a collaborative ENTIS study. Mult Scler, 2021, 27(3): 475-478.
18.	Korjagina M, Hakkarainen KM, Burkill S, et al. Prevalence of adverse pregnancy outcomes after exposure to interferon beta prior to or during pregnancy in women with MS: stratification by maternal and newborn characteristics in a register-based cohort study in Finland and Sweden. Mult Scler Relat Disord, 2021, 48: 102694.
19.	Hakkarainen KM, Juuti R, Burkill S, et al. Pregnancy outcomes after exposure to interferon beta: a register-based cohort study among women with MS in Finland and Sweden. Ther Adv Neurol Disord, 2020, 13: 1756286420951072.
20.	Schmidt AB, Lund M, Corn G, et al. Oral corticosteroids during pregnancy and offspring risk of congenital heart defects: a nationwide cohort study. Int J Epidemiol, 2020, 49(2): 638-647.
21.	Huybrechts KF, Bateman BT, Zhu Y, et al. Hydroxychloroquine early in pregnancy and risk of birth defects. Am J Obstet Gynecol, 2021, 224(3): 290.e1-290.e22.
22.	Howley MM, Papadopoulos EA, Van Bennekom CM, et al. Asthma medication use and risk of birth defects: National Birth Defects Prevention Study, 1997-2011. J Allergy Clin Immunol Pract, 2020, 8(10): 3490-3499.
23.	Yamamoto-Sasaki M, Yoshida S, Takeuchi M, et al. Association between antidepressant use during pregnancy and congenital anomalies in children: a retrospective cohort study based on Japanese claims data. Congenit Anom (Kyoto), 2020, 60(6): 180-188.
24.	Huybrechts KF, Bateman BT, Pawar A, et al. Maternal and fetal outcomes following exposure to duloxetine in pregnancy: cohort study. BMJ, 2020, 368: m237.
25.	Bandoli G, Chambers CD, Wells A, et al. Prenatal antidepressant use and risk of adverse neonatal outcomes. Pediatrics, 2020, 146(1): e20192493.
26.	Anderson KN, Lind JN, Simeone RM, et al. Maternal use of specific antidepressant medications during early pregnancy and the risk of selected birth defects. JAMA Psychiatry, 2020, 77(12): 1246-1255.
27.	Keni RR, Jose M, Reshma AS, et al. Anti-epileptic drug and folic acid usage during pregnancy, seizure and malformation outcomes: changes over two decades in the Kerala Registry of Epilepsy and Pregnancy. Epilepsy Res, 2020, 159: 106250.
28.	Elveđi-Gašparović V, Mikuš M, Beljan P, et al. The impact of antiepileptic treatment in pregnancy on perinatal outcome in Croatia - a single-center study. Acta Clin Croat, 2020, 59(4): 590-596.
29.	Patorno E, Hernandez-Diaz S, Huybrechts KF, et al. Gabapentin in pregnancy and the risk of adverse neonatal and maternal outcomes: a population-based cohort study nested in the US Medicaid Analytic eXtract dataset. PLoS Med, 2020, 17(9): e1003322.
30.	Kerr SM, Parker SE, Mitchell AA, et al. Folic acid antagonist use before and during pregnancy and risk for selected birth defects. Birth Defects Res, 2020, 112(18): 1526-1540.
31.	Hansen C, Desrosiers TA, Wisniewski K, et al. Use of antihistamine medications during early pregnancy and selected birth defects: the National Birth Defects Prevention Study, 1997-2011. Birth Defects Res, 2020, 112(16): 1234-1252.
32.	Andersson NW, Torp-Pedersen C, Andersen JT. Association between fexofenadine use during pregnancy and fetal outcomes. JAMA Pediatr, 2020, 174(8): e201316.
33.	Andersson NW, Poulsen HE, Andersen JT. Desloratadine use during pregnancy and risk of adverse fetal outcomes: a nationwide cohort study. J Allergy Clin Immunol Pract, 2020, 8(5): 1598-1605.
34.	Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J Allergy Clin Immunol, 2020, 145(2): 528-536.
35.	Fan H, Gilbert R, O'Callaghan F, et al. Associations between macrolide antibiotics prescribing during pregnancy and adverse child outcomes in the UK: population based cohort study. BMJ, 2020, 368: m331.
36.	Ji Y, Azuine RE, Zhang Y, et al. Association of cord plasma biomarkers of in utero acetaminophen exposure with risk of attention-deficit/hyperactivity disorder and autism spectrum disorder in childhood. JAMA Psychiatry, 2020, 77(2): 180-189.
37.	Lin SF, Chang SH, Kuo CF, et al. Association of pregnancy outcomes in women with type 2 diabetes treated with metformin versus insulin when becoming pregnant. BMC Pregnancy Childbirth, 2020, 20(1): 512.
38.	Mahadevan U, Long MD, Kane SV, et al. Pregnancy and neonatal outcomes after fetal exposure to biologics and thiopurines among women with inflammatory bowel disease. Gastroenterology, 2021, 160(4): 1131-1139.
39.	Andersson NW, Andersen JT. Association between fetal safety outcomes and exposure to local podophyllotoxin during pregnancy. JAMA Dermatol, 2020, 156(3): 303-311.
40.	Sakran R, Shechtman S, Arnon J, et al. Pregnancy outcome following in-utero exposure to ondansetron: a prospective comparative observational study. Reprod Toxicol, 2021, 99: 9-14.
41.	Zhu Y, Bateman BT, Gray KJ, et al. Oral fluconazole use in the first trimester and risk of congenital malformations: population based cohort study. BMJ, 2020, 369: m1494.
42.	Bateman BT, Hernandez-Diaz S, Straub L, et al. Association of first trimester prescription opioid use with congenital malformations in the offspring: population based cohort study. BMJ, 2021, 372: n102.
43.	Philipps W, Fietz AK, Meixner K, et al. Pregnancy outcome after first-trimester exposure to fosfomycin for the treatment of urinary tract infection: an observational cohort study. Infection, 2020, 48(1): 57-64.
44.	Shapira M, Avrahami I, Mazaki-Tovi S, et al. The safety of early pregnancy exposure to granisetron. Eur J Obstet Gynecol Reprod Biol, 2020, 245: 35-38.
45.	Hashimoto Y, Michihata N, Yamana H, et al. Intraocular pressure-lowering medications during pregnancy and risk of neonatal adverse outcomes: a propensity score analysis using a large database. Br J Ophthalmol, 2021, 105(10): 1390-1394.
46.	Yovich JL, Mariappen U, Hinchliffe PM, et al. MPA given orally during the first trimester for threatened miscarriage carries no specific risk for foetal abnormalities albeit the rate is higher than non-threatened pregnancies. Reprod Biol, 2020, 20(3): 424-432.
47.	Pedersen L, Petronis KR, Nørgaard M, et al. Risk of adverse birth outcomes after maternal varenicline use: a population-based observational study in Denmark and Sweden. Pharmacoepidemiol Drug Saf, 2020, 29(1): 94-102.
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49.	Andersson NW, Thomsen SF, Andersen JT. Evaluation of association between oral and topical terbinafine use in pregnancy and risk of major malformations and spontaneous abortion. JAMA Dermatol, 2020, 156(4): 375-383.
50.	Wang Z, Ho PWH, Choy MTH, et al. Advances in epidemiological methods and utilisation of large databases: a methodological review of observational studies on central nervous system drug use in pregnancy and central nervous system outcomes in children. Drug Saf, 2019, 42(4): 499-513.
51.	Palmsten K, Huybrechts KF, Mogun H, et al. Harnessing the Medicaid Analytic eXtract (MAX) to evaluate medications in pregnancy: design considerations. PLoS One, 2013, 8(6): e67405.
52.	Tan J, Xiong Y, Qi Y, et al. Data Resource Profile: Xiamen registry of pregnant women and offspring (REPRESENT): a population-based, long-term follow-up database linking four major healthcare data platforms. Int J Epidemiol, 2021, 50(1): 27-28.
53.	Sayers A, Ben-Shlomo Y, Blom AW, et al. Probabilistic record linkage. Int J Epidemiol, 2016, 45(3): 954-964.
54.	Setoguchi S, Zhu Y, Jalbert JJ, et al. Validity of deterministic record linkage using multiple indirect personal identifiers: linking a large registry to claims data. Circ Cardiovasc Qual Outcomes, 2014, 7(3): 475-480.
55.	Markus AR, Andres E, West KD, et al. Medicaid covered births, 2008 through 2010, in the context of the implementation of health reform. Womens Health Issues, 2013, 23(5): e273-280.
56.	Bateman BT, Hernandez-Diaz S, Fischer MA, et al. Statins and congenital malformations: cohort study. BMJ, 2015, 350: h1035.
57.	Bateman BT, Heide-Jørgensen U, Einarsdóttir K, et al. β-blocker use in pregnancy and the risk for congenital malformations: an international cohort study. Ann Intern Med, 2018, 169(10): 665-673.
58.	Bateman BT, Patorno E, Desai RJ, et al. Late pregnancy β blocker exposure and risks of neonatal hypoglycemia and bradycardia. Pediatrics, 2016, 138(3): e20160731.
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1. Centers for Disease Control and Prevention (CDC). Update on overall prevalence of major birth defects--Atlanta, Georgia, 1978-2005. MMWR Morb Mortal Wkly Rep. 2008, 57(1): 1-5.
2. Wilmer E, Chai S, Kroumpouzos G. Drug safety: pregnancy rating classifications and controversies. Clin Dermatol, 2016, 34(3): 401-409.
3. 谭婧, 彭晓霞, 舒啸尘, 等. 患者登记数据库构建技术规范. 中国循证医学杂志, 2019, 19(7): 771-778.
4. 孙鑫, 张俊华, 王雯, 等. 制定中国中成药真实世界研究技术指导原则, 促进中成药临床研究向决策证据转化. 中国循证医学杂志, 2020, 20(9): 993-999.
5. Huybrechts KF, Bateman BT, Hernández-Díaz S. Use of real-world evidence from healthcare utilization data to evaluate drug safety during pregnancy. Pharmacoepidemiol Drug Saf, 2019, 28(7): 906-922.
6. Huybrechts KF, Hernández-Díaz S, Straub L, et al. Association of maternal first-trimester ondansetron use with cardiac malformations and oral clefts in offspring. JAMA, 2018, 320(23): 2429-2437.
7. Lemon LS, Bodnar LM, Garrard W, et al. Ondansetron use in the first trimester of pregnancy and the risk of neonatal ventricular septal defect. Int J Epidemiol, 2020, 49(2): 648-656.
8. Benchimol EI, Smeeth L, Guttmann A, et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med, 2015, 12(10): e1001885.
9. Vandenbroucke JP, von Elm E, Altman DG, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Ann Intern Med, 2007, 147(8): W163-194.
10. Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ, 2018, 363: k3532.
11. Mendonca VJ. Maternal folic acid intake and risk of nonsyndromic orofacial clefts: a hospital-based case-control study in Bangalore, India. Cleft Palate Craniofac J, 2020, 57(6): 678-686.
12. Gildestad T, Bjørge T, Haaland ØA, et al. Maternal use of folic acid and multivitamin supplements and infant risk of birth defects in Norway, 1999-2013. Br J Nutr, 2020, 124(3): 316-329.
13. Zhang R, Guo L, Zhao D, et al. Maternal B-vitamin intake and B-vitamin supplementation during pregnancy in relation to neonatal congenital heart defects: a case-control study with propensity score matching. Eur J Clin Nutr, 2021, 75(5): 782-791.
14. Yang J, Kang Y, Cheng Y, et al. Iron intake and iron status during pregnancy and risk of congenital heart defects: a case-control study. Int J Cardiol, 2020, 301: 74-79.
15. Qu Y, Lin S, Zhuang J, et al. First-trimester maternal folic acid supplementation reduced risks of severe and most congenital heart diseases in offspring: a large case-control study. J Am Heart Assoc, 2020, 9(13): e015652.
16. Collins RT, Yang W, Carmichael SL, et al. Maternal dietary fat intake and the risk of congenital heart defects in offspring. Pediatr Res, 2020, 88(5): 804-809.
17. Pauliat E, Onken M, Weber-Schoendorfer C, et al. Pregnancy outcome following first-trimester exposure to fingolimod: a collaborative ENTIS study. Mult Scler, 2021, 27(3): 475-478.
18. Korjagina M, Hakkarainen KM, Burkill S, et al. Prevalence of adverse pregnancy outcomes after exposure to interferon beta prior to or during pregnancy in women with MS: stratification by maternal and newborn characteristics in a register-based cohort study in Finland and Sweden. Mult Scler Relat Disord, 2021, 48: 102694.
19. Hakkarainen KM, Juuti R, Burkill S, et al. Pregnancy outcomes after exposure to interferon beta: a register-based cohort study among women with MS in Finland and Sweden. Ther Adv Neurol Disord, 2020, 13: 1756286420951072.
20. Schmidt AB, Lund M, Corn G, et al. Oral corticosteroids during pregnancy and offspring risk of congenital heart defects: a nationwide cohort study. Int J Epidemiol, 2020, 49(2): 638-647.
21. Huybrechts KF, Bateman BT, Zhu Y, et al. Hydroxychloroquine early in pregnancy and risk of birth defects. Am J Obstet Gynecol, 2021, 224(3): 290.e1-290.e22.
22. Howley MM, Papadopoulos EA, Van Bennekom CM, et al. Asthma medication use and risk of birth defects: National Birth Defects Prevention Study, 1997-2011. J Allergy Clin Immunol Pract, 2020, 8(10): 3490-3499.
23. Yamamoto-Sasaki M, Yoshida S, Takeuchi M, et al. Association between antidepressant use during pregnancy and congenital anomalies in children: a retrospective cohort study based on Japanese claims data. Congenit Anom (Kyoto), 2020, 60(6): 180-188.
24. Huybrechts KF, Bateman BT, Pawar A, et al. Maternal and fetal outcomes following exposure to duloxetine in pregnancy: cohort study. BMJ, 2020, 368: m237.
25. Bandoli G, Chambers CD, Wells A, et al. Prenatal antidepressant use and risk of adverse neonatal outcomes. Pediatrics, 2020, 146(1): e20192493.
26. Anderson KN, Lind JN, Simeone RM, et al. Maternal use of specific antidepressant medications during early pregnancy and the risk of selected birth defects. JAMA Psychiatry, 2020, 77(12): 1246-1255.
27. Keni RR, Jose M, Reshma AS, et al. Anti-epileptic drug and folic acid usage during pregnancy, seizure and malformation outcomes: changes over two decades in the Kerala Registry of Epilepsy and Pregnancy. Epilepsy Res, 2020, 159: 106250.
28. Elveđi-Gašparović V, Mikuš M, Beljan P, et al. The impact of antiepileptic treatment in pregnancy on perinatal outcome in Croatia - a single-center study. Acta Clin Croat, 2020, 59(4): 590-596.
29. Patorno E, Hernandez-Diaz S, Huybrechts KF, et al. Gabapentin in pregnancy and the risk of adverse neonatal and maternal outcomes: a population-based cohort study nested in the US Medicaid Analytic eXtract dataset. PLoS Med, 2020, 17(9): e1003322.
30. Kerr SM, Parker SE, Mitchell AA, et al. Folic acid antagonist use before and during pregnancy and risk for selected birth defects. Birth Defects Res, 2020, 112(18): 1526-1540.
31. Hansen C, Desrosiers TA, Wisniewski K, et al. Use of antihistamine medications during early pregnancy and selected birth defects: the National Birth Defects Prevention Study, 1997-2011. Birth Defects Res, 2020, 112(16): 1234-1252.
32. Andersson NW, Torp-Pedersen C, Andersen JT. Association between fexofenadine use during pregnancy and fetal outcomes. JAMA Pediatr, 2020, 174(8): e201316.
33. Andersson NW, Poulsen HE, Andersen JT. Desloratadine use during pregnancy and risk of adverse fetal outcomes: a nationwide cohort study. J Allergy Clin Immunol Pract, 2020, 8(5): 1598-1605.
34. Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J Allergy Clin Immunol, 2020, 145(2): 528-536.
35. Fan H, Gilbert R, O'Callaghan F, et al. Associations between macrolide antibiotics prescribing during pregnancy and adverse child outcomes in the UK: population based cohort study. BMJ, 2020, 368: m331.
36. Ji Y, Azuine RE, Zhang Y, et al. Association of cord plasma biomarkers of in utero acetaminophen exposure with risk of attention-deficit/hyperactivity disorder and autism spectrum disorder in childhood. JAMA Psychiatry, 2020, 77(2): 180-189.
37. Lin SF, Chang SH, Kuo CF, et al. Association of pregnancy outcomes in women with type 2 diabetes treated with metformin versus insulin when becoming pregnant. BMC Pregnancy Childbirth, 2020, 20(1): 512.
38. Mahadevan U, Long MD, Kane SV, et al. Pregnancy and neonatal outcomes after fetal exposure to biologics and thiopurines among women with inflammatory bowel disease. Gastroenterology, 2021, 160(4): 1131-1139.
39. Andersson NW, Andersen JT. Association between fetal safety outcomes and exposure to local podophyllotoxin during pregnancy. JAMA Dermatol, 2020, 156(3): 303-311.
40. Sakran R, Shechtman S, Arnon J, et al. Pregnancy outcome following in-utero exposure to ondansetron: a prospective comparative observational study. Reprod Toxicol, 2021, 99: 9-14.
41. Zhu Y, Bateman BT, Gray KJ, et al. Oral fluconazole use in the first trimester and risk of congenital malformations: population based cohort study. BMJ, 2020, 369: m1494.
42. Bateman BT, Hernandez-Diaz S, Straub L, et al. Association of first trimester prescription opioid use with congenital malformations in the offspring: population based cohort study. BMJ, 2021, 372: n102.
43. Philipps W, Fietz AK, Meixner K, et al. Pregnancy outcome after first-trimester exposure to fosfomycin for the treatment of urinary tract infection: an observational cohort study. Infection, 2020, 48(1): 57-64.
44. Shapira M, Avrahami I, Mazaki-Tovi S, et al. The safety of early pregnancy exposure to granisetron. Eur J Obstet Gynecol Reprod Biol, 2020, 245: 35-38.
45. Hashimoto Y, Michihata N, Yamana H, et al. Intraocular pressure-lowering medications during pregnancy and risk of neonatal adverse outcomes: a propensity score analysis using a large database. Br J Ophthalmol, 2021, 105(10): 1390-1394.
46. Yovich JL, Mariappen U, Hinchliffe PM, et al. MPA given orally during the first trimester for threatened miscarriage carries no specific risk for foetal abnormalities albeit the rate is higher than non-threatened pregnancies. Reprod Biol, 2020, 20(3): 424-432.
47. Pedersen L, Petronis KR, Nørgaard M, et al. Risk of adverse birth outcomes after maternal varenicline use: a population-based observational study in Denmark and Sweden. Pharmacoepidemiol Drug Saf, 2020, 29(1): 94-102.
48. Anderson KN, Ailes EC, Lind JN, et al. Atypical antipsychotic use during pregnancy and birth defect risk: National Birth Defects Prevention Study, 1997-2011. Schizophr Res, 2020, 215: 81-88.
49. Andersson NW, Thomsen SF, Andersen JT. Evaluation of association between oral and topical terbinafine use in pregnancy and risk of major malformations and spontaneous abortion. JAMA Dermatol, 2020, 156(4): 375-383.
50. Wang Z, Ho PWH, Choy MTH, et al. Advances in epidemiological methods and utilisation of large databases: a methodological review of observational studies on central nervous system drug use in pregnancy and central nervous system outcomes in children. Drug Saf, 2019, 42(4): 499-513.
51. Palmsten K, Huybrechts KF, Mogun H, et al. Harnessing the Medicaid Analytic eXtract (MAX) to evaluate medications in pregnancy: design considerations. PLoS One, 2013, 8(6): e67405.
52. Tan J, Xiong Y, Qi Y, et al. Data Resource Profile: Xiamen registry of pregnant women and offspring (REPRESENT): a population-based, long-term follow-up database linking four major healthcare data platforms. Int J Epidemiol, 2021, 50(1): 27-28.
53. Sayers A, Ben-Shlomo Y, Blom AW, et al. Probabilistic record linkage. Int J Epidemiol, 2016, 45(3): 954-964.
54. Setoguchi S, Zhu Y, Jalbert JJ, et al. Validity of deterministic record linkage using multiple indirect personal identifiers: linking a large registry to claims data. Circ Cardiovasc Qual Outcomes, 2014, 7(3): 475-480.
55. Markus AR, Andres E, West KD, et al. Medicaid covered births, 2008 through 2010, in the context of the implementation of health reform. Womens Health Issues, 2013, 23(5): e273-280.
56. Bateman BT, Hernandez-Diaz S, Fischer MA, et al. Statins and congenital malformations: cohort study. BMJ, 2015, 350: h1035.
57. Bateman BT, Heide-Jørgensen U, Einarsdóttir K, et al. β-blocker use in pregnancy and the risk for congenital malformations: an international cohort study. Ann Intern Med, 2018, 169(10): 665-673.
58. Bateman BT, Patorno E, Desai RJ, et al. Late pregnancy β blocker exposure and risks of neonatal hypoglycemia and bradycardia. Pediatrics, 2016, 138(3): e20160731.
59. Huybrechts KF, Bateman BT, Palmsten K, et al. Antidepressant use late in pregnancy and risk of persistent pulmonary hypertension of the newborn. JAMA, 2015, 313(21): 2142-2151.
60. Lehtonen L, Gimeno A, Parra-Llorca A, et al. Early neonatal death: a challenge worldwide. Semin Fetal Neonatal Med, 2017, 22(3): 153-160.
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