Selected References:

• AAP Section on Breastfeeding. 2012. Policy Statement: Breastfeeding and the Use of Human Milk. Pediatrics 129(3) e827-841.
• AAP Infant Feeding in Disasters and Emergencies Fact Sheet [Accessed 9/2022] https://downloads.aap.org/AAP/PDF/DisasterFactSheet6-2020.pdf
• Centers for Disease Control and Prevention. Breastfeeding: Recommendation: Vaccinations. [Reviewed 5/2023]. https://www.cdc.gov/breastfeeding/breastfeeding-special-circumstances/vaccinations-medications-drugs/vaccinations.html.
• Centers for Disease Control and Prevention. Breastfeeding: Infectious Diseases and Specific Conditions Affecting Human Milk. [Accessed 04/2024]. https://www.cdc.gov/breastfeeding/breastfeeding-special-circumstances/maternal-or-infant-illnesses/index.html.
• Centers for Disease Control and Prevention. Breastfeeding: Recommendations: Environmental Exposures.[Accessed 04/2024]. Available from https://www.cdc.gov/breastfeeding/breastfeeding-special-circumstances/environmental-exposures/other-environmental-exposures.html.
• Centers for Disease Control and Prevention. Safety Messages for Pregnant, Postpartum, and Breastfeeding People During Natural Disasters and Severe Weather. [Reviewed 04/2024]. https://www.cdc.gov/reproductivehealth/emergency/safety-messages.htm
• General Recommendations on Immunization (2/8/2002) Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP) MMWR 51 (RR-2):1-36.
• Knap AH, et al. 2016.Environmental Exposures Due to Natural Disasters. Rev Environ Health. 31(1): 89-92.
• Rimawi BH, et al 2014. Infections and homelessness: risks of increased infectious diseases in displaced women. World Med Health Policy. 6(2):118-132

Selected References:

• Bourg M, et al. 2020. Fertility and sexuality of women with inflammatory arthritis. European Journal of Obstetrics & Gynecology and Reproductive Biology, 251:199-205. 
• Giovannopoulou E, et al. 2017. Ankylosing Spondylitis and Pregnancy: A Literature Review. Curr Rheumatol Rev. 13(3):162-169. 
• Girbash E, et al. 2023. Maternal Interleukin-17 and disease activity influence pregnancy outcomes in women with psoriatic arthritis. BMC Pregnancy Childbirth. 23(1):35. 
• Gordon D, Beastall GH, Thomson JA, et al. 1986 Androgenic status and sexual function in males with rheumatoid arthritis and ankylosing spondylitis. Q J Med; 60(231): 671–679.  
• Jakobsson GL, et al. 2016. Pregnancy outcomes in patients with ankylosing spondylitis: a nationwide register study. Ann Rheum Dis. 75(10):1838-42. 
• Lee JS, et all. 2020. Reasons for the High Cesarean Delivery Rate among Women with Ankylosing Spondylitis: Using the Korean National Health Insurance Database. The Journal of Rheumatology, 47(5) 668-673. 
• Lui NL, et al. 2011. Effect of pregnancy on ankylosing spondylitis: a case-control study. J Rheumatol 38(11):2442-4. 
• Maguire S, et al. 2020. Pregnancy in axial spondyloarthropathy–A systematic review & meta-analysis. Semin Arthritis Rheum; 50(6):1269-1279. 
• Maguire S, et al. 2022. What to expect when women with axial spondyloarthritis are expecting: Prevalence of complications of pregnancies in women with axial spondyloarthritis. Semin Arthritis Rheum; 54:151993. 
• Menekse Beser D, et al. 2023. Assessment of fetal pulmonary artery Doppler indices in pregnant women with rheumatoid arthritis and ankylosing spondylitis. J Clin Ultrasound. 51(6):983-991. 
• Mokbel A, et al. 2021. Pregnancy outcomes in women with ankylosing spondylitis: a scoping literature and methodological review. Clin Rheumatol; 40(9):3465-3480.   
• Mørk S, et al. 2021. Spondyloarthritis and outcomes in pregnancy and labor–A nationwide register-based cohort study. Arthritis Care Res, 73(2), 282-288. 
• Ostensen M. 1992. The effect of pregnancy on ankylosing spondylitis, psoriatic arthritis, and juvenile rheumatoid arthritis. Am J Reprod Immunol. 28(3-4):235-7. 
• Ostensen M & Husby G. 1989. Ankylosing spondylitis and pregnancy. Rheum Dis Clin North Am.  15(2):241-54. 
• Ostensen M & Ostensen H. 1998. Ankylosing spondylitis–the female aspect. J Rheumatol. 25(1):120-4. 
• Ostensen M, et al. 2004. A prospective study of pregnant patients with rheumatoid arthritis and ankylosing spondylitis using validated clinical instruments. Ann Rheum Dis. 63(10):1212-7.   
• Ramonda R, Foresta C, Ortolan A, et al. 2014. Influence of tumor necrosis factor α inhibitors on testicular function and semen in spondyloarthritis patients. Fertil Steril. 101(2): 359–365. 
• Saougou I1, Markatseli TE, Papagoras C, et al. 2013. Fertility in male patients with seronegative spondyloarthropathies treated with infliximab. Joint Bone Spine; 80(1): 34–37. 
• Scriffignano S, et al. 2024. Male Fertility in Spondyloarthritis: from Clinical Issues to Cytokines Milieu. A Narrative Review. Curr Rheumatol Rep. doi: 10.1007/s11926-024-01153-w.  
• Smith CJF, et al. 2020. Birth Outcomes and Disease Activity During Pregnancy in a Prospective Cohort of Women With Psoriatic Arthritis and Ankylosing Spondylitis. Arthritis Care Res, 72:1029-1037. 
• Unal C, et al. 2020. Retrospective evaluation of pregnancies with ankylosing spondylitis in a tertiary center in Turkey. Int J Rheum Dis. 23:101-105. 
• Uyaroglu OA, Seyhoglu E, Erden A, et al. 2020. Pregnancy outcomes in partners of male ankylosing spondylitis patients treated with anti-tumour necrosis factor-α biologics: real-life results from a single-centre cross-sectional study. Rheumatol Int.;40(9):1501-1507.  
• Yildirim M, et al. 2023. Assessment of fetal thymus size in pregnant women with rheumatic diseases: A case-control study. J Clin Ultrasound. 51(8): 1342-1347. 

Selected References:

• Deepaklal MC, et al. 2015. Insulin aspart in patients with gestational diabetes mellitus and pregestational diabetes mellitus. Indian J Endocrinol Metab; 19(5): 658–662. 
• Hod M, et al. 2008. Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects. Am J Obstet Gynecol’ 198(2)186.e1-7. 
• Matheisen ER, et al. 2007. Maternal glycaemic control and hypoglycaemia in Type 1 diabetes pregnancy: a randomized trial of insulin aspart vs. human insulin in 322 pregnant women. Diabetes Care; 30(4):771-776. 
• Mathiesen ER, et al. 2008. Insulin Aspart in Diabetic Pregnancy: State of the Art. Women’s Health 4(2):119-124.  
• Mathiesen ER, et al; EVOLVE study group. 2024. A comparison of the safety and effectiveness of insulin aspart with other bolus insulins in women with pre-existing Type 1 diabetes during pregnancy: A post hoc analysis of a prospective cohort study. Diabet Med; 41(10):e15411.  
• Insulin Aspart Product Label. 2023. National Institute of Health DailyMed database. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bee5b358-c863-420b-be73-ced2e920c499. Accessed 3/2026.  
• Pettitt DJ, et al. 2007. Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus. Diabet Med; 24(10): 1129–1135. 
• Shehadeh N, et al. 2001. Importance of insulin content in infant diet: suggestion for a new infant formula. Acta Paediatr; 90(1):93-95. 
• Shehadeh N, et al. 2001. Insulin in human milk and the prevention of type 1 diabetes. Pediatr Diabetes; 2(4):175-177. 
• Whitmore TJ, et al. 2012. Analysis of Insulin in Human Breast Milk in Mothers with Type 1 and Type 2 Diabetes Mellitus. Int J Endocrinol. vol. 2012: Article ID 296368.  

Selected References:  

• Abdellatif M, et al. 2019. Association between exposure to macrolides and the development of infantile hypertrophic pyloric stenosis: a systematic review and meta-analysis. Eur J Pediatr. 178:301–314.  
• Antonucci R, et al. 2022. Use of Azithromycin in Pregnancy: More Doubts than Certainties. Clinical drug invest. 42(11): 921–935.  
• Bakheit, AH, et al. 2014. Azithromycin. Profiles of Drug Substn, Excip, and Rel Methodol. 39:1-40. 
• Bérard A et al. 2015. Use of macrolides during pregnancy and the risk of birth defects: a population-based study. Pharmacoepidemiol Drug Saf 24(12):1241–1248. 
• Cooper WO, et al. 2002. Prenatal prescription of macrolide antibiotics and infantile hypertrophic pyloric stenosis. Obstet Gynecol; 100:101–106.  
• Cooper WO, et al. 2009. Antibiotics potentially used in response to bioterrorism and the risk of major congenital malformations. Paediatr Perinat Epidemiol. 23(1):18-28.  
• Damkier P, et al. 2019. In utero exposure to antibiotics and risk of congenital malformations: a population-based study. Am J Obstet Gynecol 221(6):648.e1–648.e15. 
• Fan H, et al. 2020. Associations between macrolide antibiotics prescribing during pregnancy and adverse child outcomes in the UKL Population based cohort study. BMJ 368:m331.  
• Figueroa-Romero A, et al. 2022. Drugs for intermittent preventive treatment of malaria in pregnancy: current knowledge and way forward. Trop. Med. Infect. Dis. 8(7): 152. 
• Goldstein LH, et al. 2009. The safety of macrolides during lactation. Breastfeed Med, 4(4):197-200.  
• Heikkinen T., et al. 2005. The transplacental transfer of the macrolide antibiotics erythromycin, roxithromycin and azithromycin. BJOG: An Intern Jour of Obstet and Gynaecol. 107(6):770-775. 
• Hume-Nixon M, et al. 2021. A systematic review and meta-analysis of the effect of administration of azithromycin during pregnancy on perinatal and neonatal outcomes. EClinicalMedicine 40:101123.  
• Leke, AZ, et al. 2021. Macrolide and lincosamide antibiotic exposure in the first trimester of pregnancy and risk of congenital anomaly: A European case-control study. Reprod Toxicol 100:101–108. 
• Lund M, et al. 2014. Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: nationwide cohort study. BMJ. 348:g1908.  
• Mårdh PA. 2002. Influence of infection with chlamydia trachomatis on pregnancy outcome, infant health and life-long sequelae in infected offspring. Best Pract and Research Clin Obstet and Gynaec. 16(6): 847-864. 
• Muanda FT, et al. 2017. Use of antibiotics during pregnancy and risk of spontaneous abortion. CMAJ. 189(17):625-633. 
• Pfizer Labs. 2021. Zithromax (azithromycin) label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050670s036,050710s051,050711s050,050784s037lbl.pdf. Accessed 4 Nov 2025.  
• Rahangdale L, et al. 2006. An observational cohort study of Chlamydia trachomatis treatment in pregnancy. Sex Transm Dis. 33(2):106-110. 
• Sandman Z., Iqbal OA. 2024. Azithromycin. StatPearls. Available at: https://www.ncbi.nlm.nih.gov/books/NBK557766/. Accessed 4 Nov 2025.  
• Sarkar M, et al. 2006. Pregnancy outcome following gestational exposure to azithromycin. BMC Pregnancy Childbirth. 6:18.  
• Sørensen HT, et al. 2003. Risk of infantile hypertrophic pyloric stenosis after maternal postnatal use of macrolides. Scand J Infect Dis. 35(2):104-106.  
• Sutton A, et al. 2014. Azithromycin accumulates in breast milk following a single dose for cesarean prophylaxis. AJOG. 210(1):S235.  
• Tellem R, et al. 2005. Pregnancy outcome after gestational exposure to the new macrolides: a prospective controlled cohort study. Reprod Toxicol.;20(3):484-485.  
• U.S. Centers for Disease Control and prevention. 2021. Chlamydia Infections – STI Treatment Guidelines. Available at: https://www.cdc.gov/std/treatment-guidelines/chlamydia.htm. Accessed 4 Nov 2025. 
• Wilton LV, et al. 1998. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol. 105(8): 882–889. 

Selected References:

• American Academy of Pediatrics Committee on Genetics. 2008. Maternal phenylketonuria. Pediatrics 122:445–449. 
• American College of Obstetricians and Gynecologists Committee on Genetics. 2020. Management of women with phenylalanine hydroxylase deficiency (phenylketonuria). Obstet Gynec, 135(4):e167-e170.  
• Bier C, et al. 2024. Outcomes in 14 live births resulting from Pegvaliase-treated pregnancies in PKU-affected females. Mol Genet Metab, 141(3):108152. 
• BioMarin Pharmaceutical Inc. Palynziq medication label. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6dba844a-db02-44f8-8593-ce497ed9406c&type=display. Accessed 27 October 2025.  
• Cunningham A, et al. 2023. Nutrition management of PKU with pegvaliase therapy: Update of the web-based PKU nutrition management guideline recommendations. Orphanet J Rare Dis, 18:155. 
• Fisch RO, et al. 1981 Semen studies on phenylketonurics. Biochem Med, 26(3):427434. Kopesky JJ, et al. 2024. Successful outcomes with continued pegvaliase-pqpz treatment throughout pregnancy and lactation in a PKU patient. Mol Genet Metab, 141:18. 
• Levy HL, Waisbren SE. 1983. Effects of untreated maternal phenyketonura and hyperphenylalaninemia on the fetus. N Engl J Med, 309:1269-1274.  
• Rohr F, et al. 2020. Discontinuation of pegvaliase therapy during maternal PKU pregnancy and postnatal breastfeeding: A case report. Mol Genet Metab Rep, 22:100555.  
• Rohr F, et al. 2022. Reinstitution of pegvaliase therapy during lactation. Mol Genet Metab Rep, 33:100938.  
• Teissier R, et al. 2012. Maternal phenylketonuria: low phenylalaninemia might increase the risk of intra uterine growth retardation. J Inherit Metab Dis, 35(6):993-999.  
• U.S. Food and Drug Administration Center for Drug Evaluation and Research. Active Risk Identification and Assessment (ARIA) Sufficiency Memo for Pregnancy Safety Concerns. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761079Orig1s000OtherR.pdf. Accessed 27 October 2025. 
• Waisbren SE, et al. 2015. Maternal phenylketonuria: long-term outcomes in offspring and post-pregnancy maternal characteristics. JIMD Rep, 21:23-33.