Selected References:

• American Academy of Pediatrics. 2025. Recommendations for Prevention and Control of Influenza in Children, 2025–2026: Policy Statement. Pediatrics. Available at: https://doi.org/10.1542/peds.2025-073620. [Accessed 8/2025]. 
• Becerra-Culqui TA, et al. 2022. Prenatal influenza vaccination or influenza infection and autism spectrum disorder in offspring. Clin Infect Dis; 75(7):1140-1148.  
• Centers for Disease Control and Prevention. 2025-2026. Information for the Flu Season. Available at https://www.cdc.gov/flu/season/index.html. [Accessed 6/2026]. 
• Centers for Disease Control and Prevention. 2025-2026. Flu Vaccine Safety and Pregnancy. Available at: https://www.cdc.gov/flu/vaccine-safety/vaccine-pregnant.html [Accessed 6/2026]. 
• Centers for Disease Control and Prevention. 2025. Influenza Vaccine Safety Considerations during Pregnancy or while Breastfeeding. Available at: https://www.cdc.gov/flu/hcp/vax-summary/vaccine-safety-pregnant.html. [Accessed 6/2026]. 
• Centers for Disease Control and Prevention. 2024. Vaccines for Family and Caregivers. Available at:  https://www.cdc.gov/vaccines-pregnancy/about/vaccines-family-caregivers.html. [Accessed 6/2026]. 
• Conlin AMS, et al. 2018. A follow-up comparative safety analysis of pandemic H1N1 vaccination during pregnancy and risk of infant birth defects among U.S. military mothers. Vaccine; 36(20):2855-2860. 
• Chaiken SR, et al. 2022. Cost-effectiveness of influenza vaccination during pregnancy. J Matern Fetal Neonatal Med; 35(25):5244-5252. 
• Chambers CD, et al. 2013. Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants. Vaccine, 31(44):5026-5032.  
• Committee on Infectious Diseases. 2024. Recommendations for Prevention and Control of Influenza in Children, 2024-2025: Technical Report. Pediatrics; 154(4):e2024068508.  
• Donahue JG, e al. 2019. Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15. Vaccine, 37(44):6673-6681.  
• Fabiani M, et al. 2015. A/H1N1 pandemic influenza vaccination: A retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy. Vaccine, 33(19):2240-2247. 
• Fell DB, et al. 2024. Effectiveness of influenza vaccination during pregnancy against laboratory-confirmed seasonal influenza among infants under 6 months of age in Ontario, Canada. J Infect Dis; 25;230(1):e80-e92. 
• Foo DYP, et al. 2020. Early childhood health outcomes following in utero exposure to influenza vaccines: a systematic review. Pediatrics; 146(2):e20200375. 
• Getahun D, et al. 2019. Association between seasonal influenza vaccination with pre- and postnatal outcomes. Vaccine, 37(13):1785-1791. Getahun D, et al. 2024.
• Safety of the seasonal influenza vaccine in 2 successive pregnancies. JAMA Netw Open; 7(9):e2434857. Grohskopf LA, et al. 2024. Prevention and Control of
• Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2024–25 Influenza Season. MMWR Recomm Rep; 2024;73(No. RR-5):1–25.  
• Gunatilaka A, et al.2023. Protective effect of maternal immunization on birth outcomes: A data linkage study. Int J Gynaecol Obstet. 162(1):51-57.  
• Gunnes N, et al. 2020. Seasonal and pandemic influenza during pregnancy and risk of fetal death: a Norwegian registry-based cohort study. Eur J Epidemiol, 35(4):371-379. 
• Haberg S, et al. 2013. Risk of fetal death after pandemic influenza virus infection or vaccination. N Engl J Med, 368(4):333-340. 
• Hall C, et al. 2025. Receipt of Tdap or Influenza vaccine during pregnancy and odds of clinical chorioamnionitis: A nested case-control study. Pharmacoepidemiol Drug Saf. 34(4):e70147. 
• Hunagund S, et al. 2022. Effects of vaccination against influenza, pertussis, and COVID-19 on human milk antibodies: Current evidence and implications for health equity. Front Immunol; 13:910383. 
• Hviid A, et al. 2017. Association between pandemic influenza A (H1N1) vaccination in pregnancy and early childhood morbidity in offspring. JAMA Pediatr, 171(3):239-248. 
• Irving SA, et al. 2013. Trivalent inactivated influenza vaccine and spontaneous abortion. Obstet Gynecol, 121(1):159-165. 
• Jamieson, Denise J.  et al. 2026, Maternal Immunization. Obstetrics & Gynecology; 147(5):p 661-678. 
• Kharbanda EO, et al. 2013. Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events. Obstet Gynecol, 122(3):659-667. 
• Kharbanda EO, et al. 2017. First trimester influenza vaccination and risks for major structural birth defects in offspring. J Pediatr, 187:234-239.e4. 
• Lee H, et al. 2025. Association of Influenza Vaccination During Pregnancy with Health Outcomes in Mothers and Children: A Population-Based Cohort Study. Clin Pharmacol Ther. 117(5):1381-1392. 
• Legge A, et al. 2014. Rates and determinants of seasonal influenza vaccination in pregnancy and association with neonatal outcomes. CMAJ, 186(4):E157E163.  
• Ludvigsson JF, et al. 2015. Maternal vaccination against H1N1 influenza and offspring mortality: population-based cohort study and sibling design. BMJ, 351:h5585. 
• Ludvigsson JF, et al. 2020. Maternal influenza A(H1N1) immunization during pregnancy and risk for autism spectrum disorder in offspring : a cohort study. Ann Intern Med, 173(8):597-604. 
• Malange V, et al, Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS). 2025. Influenza vaccination during early pregnancy and risk of major birth defects, US Birth Defects Study To Evaluate Pregnancy exposureS, 2014-2019. Vaccine. 59:127297. 
• Maloney P, et al. 2026. Interim Estimates of 2025-26 Seasonal Influenza Vaccine Effectiveness – United States, September 2025-February 2026. MMWR Morb Mortal Wkly Rep; 12;75(9):116-123.  
• McHugh L, et al. 2017. Birth outcomes for Australian mother-infant pairs who received an influenza vaccine during pregnancy, 2012-2014: the FluMum study. Vaccine, 35(10):1403-1409. 
• Mehrabadi A, et al. 2021. Association of maternal influenza vaccination during pregnancy with early childhood health outcomes. JAMA, 325(22):2285-2293. 
• Moro PL, et al. 2011. Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009. Am J Obstet Gynecol, 204(2):146.e1-146.e1467.  
• Moro PL et al. 2021. Reports of cell-based influenza vaccine administered during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2013-2020. Vaccine, 39(4):678-681. 
• Munoz FM, et al. 2005: Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol, 192(4):1098-1106. 
• Nassar AH, et al. 2023. Vaccination in pregnancy. Int J Gynaecol Obstet; 162(1):18-23. 
• Neuzil KM, et al. 1998. Impact of influenza on acute cardiopulmonary hospitalizations in pregnant women. Am J Epidemiol, 148(11):1094-1102. 
• Nordin JD, et al. 2014. Maternal influenza vaccine and risks for preterm or small for gestational age birth. J Pediatr, 164(5):1051-1057.e2. 
• Nwoji U. 2022. Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry. Hum Vaccin Immunother, 18(1):1932213. 
• Ohfuji S, et al. 2020. Safety of influenza vaccination on adverse birth outcomes among pregnant women: a prospective cohort study in Japan. Int J Infect Dis, 93:68-76. 
• Palmsten K, et al. 2023. Influenza vaccination during pregnancy and risk of selected major structural congenital heart defects, National Birth Defects Prevention Study 2006-2011. Birth Defects Res; 115(1):88-95. 
• Pasternak B, et al. 2012. Risk of adverse fetal outcomes following administration of a pandemic influenza A (H1N1) vaccine during pregnancy. JAMA, 308(2):165-174.  
• Poehling KA, et al, New Vaccine Surveillance Network. 2011. Impact of maternal immunization on influenza hospitalizations in infants. Am J Obstet Gynecol, 204(6 Suppl 1):S141-8. 
• Pool V, Iskander J. 2006 Safety of influenza vaccination during pregnancy. Am J Obstet Gynecolc 194:1200; author reply 1201. 
• Regan AK, et al. 2024. Maternal influenza vaccination and associated risk of fetal loss: A claims-based prospective cohort study. Vaccine. 42(26):126256. 
• Regan AK, et al. 2023. Risk of miscarriage in relation to seasonal influenza vaccination before or during pregnancy. Obstet Gynecol. 142(3):625-635.  
• Robinson C, et al. 2022. A prospective cohort study on pregnancy outcomes of persons immunized with a seasonal quadrivalent inactivated influenza vaccine during pregnancy. Vaccines (Basel). 10(10):1577.  
• Romano CJ et al. 2021. History of pandemic H1N1-containing influenza vaccination and risk for spontaneous abortion and birth defects. Vaccine, 39(44):6553-6562. 
• Sakala IG, et al. 2023. Developmental and reproductive safety of Advax-CpG55.2™ adjuvanted COVID-19 and influenza vaccines in mice. Vaccine. :S0264-410X(23)01007-1.  
• Sarna M et al. 2022 The risk of major structural birth defects associated with seasonal influenza vaccination during pregnancy: A population-based cohort study. Birth Defects Res. 114(19):1244-1256. 
• Sarna M, et al. 2025. Neonatal and infant mortality after maternal influenza and pertussis vaccination: Probabilistically linked cohort study. Hum Vaccin Immunother; 21(1):2587307.  
• Shaikh H, et al. 2023. Safety and protective effects of influenza vaccination in pregnant women on pregnancy and birth outcomes in Pune, India: A cross-sectional study. Vaccines (Basel). 11(6):1034. 
• Sheffield J, et al. 2004. The efficacy and safety of influenza vaccination in pregnancy. Am J Obstet Gynecol, 191(6 Suppl):S66. 
• Siston A, et al. 2010, Pandemic 2009 influenza A(H1N1) virus illness among pregnant women in the United States. JAMA, 303(15):1517-1525. 
• Tamma et al. 2009. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol, 201(6):547-552. 
• Tchuente V, et al 2026. Maternal influenza vaccination during pregnancy and the risk of adverse pregnancy and birth outcomes. Front Pharmacol; 5;16:1691111.  
• Thompson MG, et al. 2018. Influenza vaccine effectiveness in preventing influenza-associated hospitalizations during pregnancy: a multi-country retrospective test negative design study, 2010–2016. Clin Infect Dis, 68(9):1444–1453. 
• Xie S, et al. 2023. The association between maternal influenza vaccination during pregnancy and adverse birth outcomes in the United States: Pregnancy risk Assessment Monitoring System (PRAMS). Vaccine. 41(13):2300-2306. 
• Zaman K, et al. 2008. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med; 359(15):1555-1564. 
• Zasztowt-Sternicka M, et al. 2025. Immunogenicity of inactivated quadrivalent influenza vaccine in pregnant women, including the level of postvaccination antibodies in umbilical cord blood. Vaccine. 19;53:127047. 
• Zerbo O, et al. 2017. Association between influenza infection and vaccination during pregnancy and risk of autism spectrum disorder. JAMA Pediatr, 171(1):e163609. 
• Zerbo O, et al. 2025. Influenza vaccination during pregnancy and infant influenza in the first 6 months of life. Obstet Gynecol; 146(2):e36-e42. 
• Zhang X, et al. 2026. The Impact of Maternal Influenza Infection and Vaccination During Pregnancy on Birth Outcomes. Pediatr Infect Dis J. 10.1097/INF.0000000000005194. Epub ahead of print.  

Selected References:

• Blackmore-Prince C, et al. 1999. Chemical hair treatments and adverse pregnancy outcome among Black women in central North Carolina. Am J Epidemiol, 149:712-716. 
• Borowska S, et al. 2015. Metals in cosmetics: implications for human health. J Appl Toxicol, 35: 551–572 
• Burnett C, et al. 1976. Teratology and percutaneous toxicity studies on hair dyes. J Toxicol Environ Health, 1:1027-1040. 
• Chan M, et al. 2023. Use of personal care products during pregnancy and birth outcomes – a pilot study. Environ Res, 225:115583.  
• DiNardo JC, et al. 1985. Teratological assessment of five oxidative hair dyes in the rat. Toxicology and Applied Pharmacology, 78:163-166. 
• Gallicchio L, et al. 2010. Health outcomes of children born to cosmetologists compared to children of women in other occupations. Reprod Toxicol, 29:361-365. 
• Ghazarian AA. et al. 2018. Maternal use of personal care products during pregnancy and risk of testicular germ cell tumors in sons. Environ Res, 164:109-113. 
• Guerra-Tapia A, Gonzalez-Guerra E.. 2014 Hair cosmetics: dyes. Actas Dermo-sifiliogr, 105(9):833-839. 
• Goebel C, et al. 2012. Quantitative risk assessment for skin sensitisation: consideration of a simplified approach for hair dye ingredients. Regul Toxicol Pharmacol, 64(3):459–465. 
• Haraux E, et al. 2016. Maternal exposure to domestic hair cosmetics and occupational endocrine disruptors is associated with a higher risk of hypospadias in offspring. Int J Environ Res Public Health, 14(1):1071.  
• Herdt-Losavio ML et al. 2009. The risk of congenital malformations and other neonatal and maternal health outcomes among licensed cosmetologists. Am J Perinatol, 26:625-631. 
• Henrotin JB, et al. 2015. Reproductive disorders in hairdressers and cosmetologists: a meta-analytical approach. J Occup Health, 57:485-496. 
• Inouye M. and Murakami U. 1977. Teratogenicity of 2,5-diaminotoluene, a hair dye constituent, in mice. Food and Cosmetics Toxicology, 15(5):477-451. 
• Jiang C, et al. 2018. The effect of pre-pregnancy hair dye exposure on infant birth weight: a nested case-control study. BMC Pregnancy Childbirth, 18(1):144.  
• John EM, et al. 1994. Spontaneous abortions among cosmetologists. Epidemiol, 5:147-155. 
• Kersemaekers WM, et al. 1996. Reproductive disorders among hairdressers. Epidemiol, 8:396-401. 
• Ki-Hyun K, et al. 2016. The use of personal hair dye and its implications for human health. Environ Int, 89–90:222–227. 
• Kim D. et al. 2016. Reproductive disorders among cosmetologists and hairdressers: a meta-analysis. Int Arch Occup Environ Health, 89(5):739-53. 
• Kojima R, et al. 2021. Association between gestational hair dye use and allergies at 3 years old: the Japan environment and Children’s study. Environ Res, 201:111530. 
• Maibach HI, et al. 1975. Percutaneous penetration following use of hair dyes. Arch Dermatol, 111:1444-1445. 
• Marks TA, et al. 1979. Teratogenicity of 4-nitro-1,2-diainobenzene (4NDB) and 2-nitro-1,4-diaminobenzene (2NDB) in the mouse. Teratology, 19:37A-38A. 
• Marks TA, et al. 1981. Teratogenic evaluation of 2-nitro-p-phenylendiamine, 4-nitro-o-phenylenediamine, and 2,5-toluenediamine sulfate in the mouse. Teratology, 24:253-265. 
• Occupational Safety and Health Administration (OSHA). 2011. Hair Smoothing Products That Could Release Formaldehyde. Hazard Alert Update. Available at: https://www.osha.gov/sites/default/files/publications/hazard_alert.pdf [Accessed 2024]. 
• Ooka T, et al. 2021. Association between maternal exposure to chemicals during pregnancy and the risk of feotal death: the Japan Environment and Children’s Study. Int J Environ Res Public Health, 18(22):11748.  
• Peretz J, et al. 2009. Infertility among cosmetologists. Reprod Toxicol, 28(3):359-364. 
• Preston EV, et al. 2021. Endocrine disrupting chemical-associated hair product use during pregnancy and gestational age at delivery: a pilot study. Environ Health, 20(1):86.  
• Quach T, et al. 2015. Adverse birth outcomes and maternal complications in licensed cosmetologists and manicurists in California. Int Arch Occup Environ Health, 88:823-833. 
• Quiros-Alcala L. et al. 2019. Occupational exposures among hair and nail salon workers: a scoping review. Curr Environ Health Rep, 6(4):269-285. 
• Riveria-Núñez Z, et al. 2022. Personal care products: Demographic characteristics and maternal hormones in pregnant women from Puerto Rico. Environ Res, 206:112376.  
• Rylander L, et al. 2002. Reproductive outcome among female hairdressers. Occup Environ Med, 59:517-522. 
• Siegel MR. et al. 2022. Maternal occupation as a nail technician or hairdresser during pregnancy and birth defects, National Birth Defects Prevention Study, 1997-2011. Occup Environ Med. 79(1):17-23. 
• Shawahna R. 2021. Breast milk to blood lead ratios among women from the West Bank of Palestine: a cross-sectional study of associated factors. Int Breastfeed J, 16(1):61.  
• Shawahna R, et al. 2023. Breastmilk cadmium levels and estimated infant exposure: a multicenter study of associated factors in a resource-limited country. Int Breastfeed J, 18(1):36.  
• Shishavan MK, et al. 2021. The association of hair coloring during pregnancy with pregnancy and neonatal outcomes: a cross-sectional study. International Journal of Women’s Health and Reproduction Sciences, 9 (2):130–135. 
• Tokinobu A, et al. 2023. Pre- and postnatal maternal hair dye use and risk of wheeze and asthma in 5-year-old Japanese children: the Kyushu Okinawa Maternal and Child Health Study. Int J Environ Health Res, 33(12):1697-1705.  
• U.S. Food and Drug Administration (FDA). 2024. Hair Smoothing Products That Release Formaldehyde When Heated. https://www.fda.gov/cosmetics/cosmetic-products/hair-smoothing-products-release-formaldehyde-when-heated. [Accessed 2024]. 
• U.S. Food and Drug Administration (FDA). 2024. Cosmetics & Pregnancy. https://www.fda.gov/cosmetics/resources-consumers-cosmetics/cosmetics-pregnancy. [Accessed 2024] 
• U.S. Food and Drug Administration (FDA). 2024. Hair Products. https://www.fda.gov/cosmetics/cosmetic-products/hair-products. [Accessed 2024] 
• Wise LA, et al. 2023. Use of chemical hair straighteners and fucundability in a North American Preconception Cohort. Am J Epidemiol, 192(7): 1066-1080.  
• Zanonia TB, et al. 2014. Basic Red 51, a permitted semi-permanent hair dye, is cytotoxic tohuman skin cells: studies in monolayer and 3D skin model using human keratinocytes (HaCaT). Toxicol Lett, 227(2):139-149. 
• Zhu JL, et al. 2006. Pregnancy outcomes among female hairdressers who participated in the Danish National Birth Cohort. ScandJ Work Environ Health, 32(1):61-66. 
• Zota AR, et al. 2017. The environmental injustice of beauty: framing chemical exposures from beauty products as a health disparities concern. Am J Obstet Gynecol, 217(4):418-422. 

Selected References:

• Askew J, 2007. Zolpidem addiction in pregnant woman with a history of second trimester bleeding. Pharmacotherapy, 27(2):306-308. 
• Huitfeldt A, et al. 2020. Associations of maternal use of benzodiazepines or benzodiazepine-like hypnotics during pregnancy with immediate pregnancy outcomes in Norway. JAMA Netw Open, 3(6):e205860.  
• Fung K, et al. 2026. Z-drug use in the first trimester of pregnancy and risk of congenital malformations. JAMA Psychiatry,83(2): 162-171. 
• Grigoriadis S, et al. 2022. Hypnotic benzodiazepine receptor agonist exposure during pregnancy and the risk of congenital malformations and other adverse pregnancy outcomes: a systematic review and meta-analysis. Acta Psychiatr Scand, 146(4):312‐324. 
• Juric S, et al. 2009. Zolpidem in pregnancy: placental passage and outcome. Arch Womens Ment Health, 12:441-446. 
• Lupattelli A, et al. 2019. Association of maternal use of benzodiazepines and z-hypnotics during pregnancy with motor and communication skills and attention-deficit/hyperactivity disorder symptoms in preschoolers. JAMA Netw Open, 2(4):e191435.  
• Meng L, et al. 2024. Association between maternal benzodiazepine or z-hypnotic use in early pregnancy and the risk of stillbirth, preterm birth, and small for gestational age: a nationwide, population-based cohort study in Taiwan. Epilepsy Currents, 24(2)105-107.  
• Pons G, et al. 1989. Zolpidem excretion in breast milk. Eur J Clin Pharmacol, 37:245-248. 
• Reichner C. 2015. Insomnia and sleep deficiency in pregnancy. Obstetric Medicine,8(4):168-171. 
• Saito J, et al. 2022. Presence of hypnotics in the cord blood and breast milk, with no adverse effects in the infant: a case report. Breastfeeding Med, 17(4):349-352. 
• Sundbakk LM, et al. 2022. Association of prenatal exposure to benzodiazepines and z-hypnotics with risk of attention-deficit/hyperactivity disorder in childhood. JAMA Netw Open, 5(12):e2246889.  
• Wang LH, et al. 2010. Increased risk of adverse pregnancy outcomes in women receiving zolpidem during pregnancy. Clinical Pharmacology and Therapeutics, 88(3):369-374. 
• Wikner BN, Kallen B. 2011. Are hypnotic benzodiazepine receptor agonists teratogenic in humans? Journal of Clinical Psychopharmacology, 31(3):356-359. 

Selected References:

• Abolhassani N, et al. 2023. Major malformations risk following early pregnancy exposure to metformin: a systematic review and meta-analysis. BMJ Open Diab Res Care: 11(1):e002919. 
• Bhorat I, et al. 2019. Assessment of the fetal myocardial performance index in well‐controlled gestational diabetics & to determine whether it is predictive of adverse perinatal outcome. Pediatr Cardiol. 40(7):1460–1467. 
• Boggess KA, et al. 2023. Metformin plus insulin for preexisting diabetes or gestational diabetes in early pregnancy: The MOMPOD randomized clinical trial. JAMA. 330(22):2182-2190. 
• Brand KMG, et al. 2022. Metformin in pregnancy and risk of adverse long-term outcomes: a register-based cohort study. BMJ Open Diab Res Care. 10(1): e002363. 
• Brand KM, et al. 2022. Metformin in pregnancy and risk of abnormal growth outcomes at birth: a register-based cohort study. BMJ Open Diab Res Care: 10(6), e003056. 
• Briggs GG, et al. 2005. Excretion of metformin into breast milk and the effect on nursing infants. Obstet Gynecol 105(6):1437-1441. 
• Cassina M, et al. 2014. First-trimester exposure to metformin and risk of birth defects: a systematic review and meta-analysis. Hum Reprod Update. 20(5):656-669. 
• Coetzee EJ, et al. 1980. Pregnancy in established non-insulin-dependent diabetics: A five-and-a-half year study at Groote Schuur Hospital. S Afr Med J. 58(20):795-802. 
• Coetzee EJ, et al. 1984. Oral hypoglycaemics in the first trimester and fetal outcome. S Afr Med J. 65(16):635-637. 
• Dhulkotia JS, et al. 2010. Oral hypoglycemic agents vs insulin in management of gestational diabetes: a systematic review and metaanalysis. Am J Obstet Gynecol. 203(5):457.e1-9. 
• Diav-Citrin O, et al. 2018. In-utero exposure to metformin for type 2 diabetes or polycystic ovary syndrome: A prospective comparative observational study. Reprod Toxicol. 80:85-91. 
• Farladansky-Gershnabel S, et al. 2025. Predictors of small-for-gestational-age infants in gestational diabetes mellitus: the impact of metformin use. Arch Gynecol Obstet. 312(2):445-450. 
• Feig DS, et al. 2007. Oral antidiabetic agents in pregnancy and lactation: a paradigm shift? Ann Pharmacother. 41(7):1174-1180. 
• Feig DS, et al. 2023. Outcomes in children of women with type 2 diabetes exposed to metformin versus placebo during pregnancy (MiTy Kids): a 24-month follow-up of the MiTy randomised controlled trial. Lancet Diabetes Endocrinol. 11(3):191–202. 
• Filippi-Arriaga F, et al. 2025. EASO Position Statement: Women with Obesity across the Reproductive Life – Fertility, Preconception, Pregnancy, Postpartum, and Breastfeeding. Obes Facts. 18(6):625-639.  
• Fornes R, et al. 2022. Pregnancy, perinatal and childhood outcomes in women with and without polycystic ovary syndrome and metformin during pregnancy: a nationwide population-based study. Reprod Biol Endocrinol. 20(1):30. 
• Gardiner SJ, et al. 2003. Transfer of metformin into human milk. Clin Pharmacol Ther. 73(1):71-77. 
• Ghazeeri GS, et al. 2012. Pregnancy outcomes and effect of metformin treatment in women with polycystic ovary syndrome: an overview. Acta Obstet Gynecol Scand. 91(6):658–678. 
• Gilbert C, et al. 2006. Pregnancy outcome after first-trimester exposure of metformin: a meta-analysis. Fertil Steril. 86(3):658-663. 
• Glueck CJ, et al. 2001. Continuing metformin throughout pregnancy in women with polycystic ovary syndrome appears to safely reduce first-trimester spontaneous abortion: a pilot study. Fertil Steril. 75(1):46-52. 
• Glueck CJ, et al. 2002. Pregnancy outcomes among women with polycystic ovary syndrome treated with metformin. Hum Reprod 17(11):2858-2864. 
• Glueck CJ, et al. 2004. Height, weight, and motor-social development during the first 18 months of life in 126 infants born to 109 mothers with polycystic ovary syndrome who conceived on and continued metformin through pregnancy. Hum Reprod. 19(6):1323-1330. 
• Glueck CJ, et al. 2006. Growth, motor, and social development in breast- and formula-fed infants of metformin-treated women with polycystic ovary syndrome. J Pediatr 148(5):628-632. 
• Glueck CJ et al. 2008. Prevention of gestational diabetes by metformin plus diet in patients with polycystic ovary syndrome. Fertil Steril 89:625-634. 
• Glueck CJ, et al. 2013. Effects of metformin-diet intervention before and throughout pregnancy on obstetric and neonatal outcomes in patients with polycystic ovary syndrome. Current Med Res Opin. 29(1): 55-62. 
• Greger HK, et al. 2020. Cognitive function in metformin exposed children, born to mothers with PCOS-follow-up of an RCT. BMC Pediatr. 20(1):60. 
• Gordon HG, et al. 2024. Metformin in pregnancy and childhood neurodevelopmental outcomes: a systematic review and meta-analysis. Am J Obstet Gynecol. 231(3):308-314. 
• Jakubowicz D, et al.. 2002. Effects of metformin on early pregnancy loss in the polycystic ovary syndrome, J Clin Endocrinol Metab. 87(2): 524-529. 
• Meek CL. 2023. An unwelcome inheritance: childhood obesity after diabetes in pregnancy. Diabetologia, 66(11), 1961-1970. 
• Newman C, et al.. 2022. Metformin for pregnancy and beyond: the pros and cons. Diabet Med. 39(3):e14700. 
• Newman C, et al. 2024. Treatment of diabetes in pregnancy with metformin. Obstet Gynecol. 144(5):660-669. 
• Panchaud A, et al. 2018. Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information services. Br J Clin Pharmacol. 84(3):568-578. 
• Paschou SA, et al. 2024. Efficacy and safety of metformin during pregnancy: an update. Endocrine. 83(2):259-269.  
• Picon-Cesar MJ, et al 2021. Metformin for gestational diabetes study: metformin vs insulin in gestational diabetes: glycemic control and obstetrical and perinatal outcomes: randomized prospective trial. Am J Obstet Gynecol. 225(5):517.e1-517.e17. 
• Rotem RS, et al. 2024. paternal use of metformin during the sperm development period preceding conception and risk for major congenital malformations in newborns. Ann Intern Med. 177(7):851-861. 
• Tarry-Adkins J, et al. 2019. Neonatal, infant, and childhood growth following metformin versus insulin treatment for gestational diabetes: A systemic review and meta-analysis. PLoS Med. 16(8): e1002848. 
• Tavlo M, et al. 2022. Hypothesis: Metformin is a potential reproductive toxicant. Front Endocrinol (Lausanne). 13: 1000872. 
• Tosti G, et al. 2023. Lights and shadows on the use of metformin in pregnancy: from the preconception phase to breastfeeding and beyond. Front Endocrinol (Lausanne). 14: 1176623. 
• Tseng CH. 2022. The effect of metformin on male reproductive function and prostate: An updated review. World J Mens Health. 40(1): 11-29. 
• Wensink MJ, et al. Preconception antidiabetic drugs in men and birth defects in offspring: a nationwide cohort study. Ann Intern Med. 2022;175(5):665-673.  
• Wouldes TA, et al. 2016 Neurodevelopmental outcome at 2 years in offspring of women randomised to metformin or insulin treatment for gestational diabetes. Arch Dis Child Fetal Neonatal Ed. 101(6):F488-F493. 
• Yanachkova VE, et al. 2024. Metformin-associated maternal and neonatal outcomes in women with gestational diabetes – a retrospective cohort study. Ginekol Pol. 95(4):259-265. 
• Yland JJ, et al. 2024. Perinatal outcomes associated with metformin use during pregnancy in women with pregestational type 2 diabetes mellitus. Diabetes Care. 47(9):1688-1695. 
• Yu YH, et al. 2025. Metformin and risk of adverse pregnancy outcomes among pregnant women with gestational diabetes in the United Kingdom: A population-based cohort study. Diabetes Obes Metab. 27(2):976-986. 

Selected References: 

• Bellomo C, et al. 2019. A newborn infected by Andes virus suggests novel routes of hantavirus transmission: a case report. Clin Microbiol Infect; 26(1):130-131.
• Centers for Disease Control and Prevention. 2024. About Hantavirus. Available at: https://www.cdc.gov/hantavirus/about/index.html. [Accessed May 7, 2026]. 
• Centers for Disease Control and Prevention. 2026. Clinician Brief: Hantavirus Pulmonary Syndrome (HPS). Available at: https://www.cdc.gov/hantavirus/hcp/clinical-overview/hps.html. [Accessed May 31, 2026].
• Centers for Disease Control and Prevention. 2024. Hantavirus Prevention. Available at: https://www.cdc.gov/hantavirus/prevention/index.html. [Accessed May 7, 2026]. 
• Centers for Disease Control and Prevention. 2026. About Andes Virus. Available at: https://www.cdc.gov/hantavirus/about/andesvirus.html. [Accessed May 13, 2026].
• Douglas KO, Gittens-St Hilaire M. 2024. First clinical reports of acute hantavirus and dengue infections among pregnant women in the Caribbean. Infect Dis (Lond); 56(7):564-574.
• Ferrés M, et al. 2020. Mother-to-Child Transmission of Andes Virus through Breast Milk, Chile1. Emerg Infect Dis;’. (8):1885-1888. 
• Führer A, et al. 2012. Hantavirusinfektion durch Dobrava-Belgrad-Virus bei einer schwangeren Patientin im 3. Trimenon [Hantavirus infection due to Dobrava-Belgrade virus in a third trimester pregnant woman]. Dtsch Med Wochenschr. 137(46):2369-72. German. 
• Georges CG, et al. 2008. Nephropathia epidemica als Folge einer Puumala-Virus-Infektion bei einer schwangeren Patientin [Nephropathia epidemica as the result of a Puumala virus infection in a pregnant patient]. Dtsch Med Wochenschr. 133(37):1830-2. German. 
• Gilson GJ, et al. 1994. Hantavirus pulmonary syndrome complicating pregnancy. Am J Obstet Gynecol. 171(2):550-4. 
• Hofmann J, et al. 2012. Hantavirus infections by Puumala or Dobrava-Belgrade virus in pregnant women. J Clin Virol; 55(3):266-9, 2012
• Howard MJ, et al. 1999. Hantavirus pulmonary syndrome in pregnancy. Clin Infect Dis; 29(6):1538-44.
• Janwadkar RS, et al. 2025. Unexpected Challenges: A Case Report of Hantavirus Infection in a Pregnant Patient in a Rural Emergency Department. J Emerg Med; 77:84-88. 
• Ji F, et al. 2017. Hemorrhagic fever with renal syndrome caused by Hantaan virus infection in four pregnant Chinese women. J Med Virol. 89(10):1865-1870. 
• Kim BN, Choi BD. 2006. Hemorrhagic fever with renal syndrome complicated with pregnancy: a case report. Korean J Intern Med. Jun;21(2):150-3. 
• Latus J, et al. 2013. The case: fever, myalgia, visual disorders, and acute kidney failure in a pregnant woman. Diagnosis: Severe acute hantavirus infection. Kidney Int. 84(3):629-31.
• Liu XL, et al. 2017. Epidemic hemorrhagic fever complicated with late pregnancy: A case report. Medicine (Baltimore); 96(40):e8137.
• Lu DH, et al. 2021. Hantavirus infection during pregnancy. Virol Sin 36(3):345-353. Erratum in: Virol Sin; 36(4):829.
• Lu DH, et al. 2021. Correction to: Hantavirus infection during pregnancy. Virol Sin; 36(4):829.
• Ma RM, et al. 2003. Hemorrhagic fever with renal syndrome presenting with intrauterine fetal death. A case report. J Reprod Med. 48(8):661-4. 
• Macé G, et al. 2013. Severe Seoul hantavirus infection in a pregnant woman, France, October 2012. Euro Surveill; 18(17):20464.Silberberg L, et al. 1993. Haemorrhagic fever with renal syndrome and pregnancy: a case report. Trans R Soc Trop Med Hyg; 87(1):65.
• Todorović Z, et al. 2010. Hemorrhagic fever with renal syndrome during pregnancy: case report. Med Pregl; 63(3-4):280-4.
• Ying X, et al. 2020. Continuous renal replacement therapy rescues severe haemorrhagic fever with renal syndrome in pregnancy: a case report. BMC Infect Dis. 20(1):920. 
• Züst, R., et al. 2023. Presence and persistence of Andes Virus RNA in human semen. Viruses, 15(11), 2266.