| Study | Exclusion reasons | Rmk | Reference |
|---|---|---|---|
| Aggarwal, 2011 | inadequate or absent control group | EXCLUDED : Absent control group. | |
| Martinez-Rueda, 1996 | inadequate or absent control group | EXCLUDED: Controls may have been exposed to other treatments, such as chloroquine or cyclophosphamide, which may not be safe. => No adequate control group. | |
| Fischer-Betz, 2013 | inadequate or absent control group | EXCLUDED : inadequate control group. The study compares outcome in pregnancies in a group of women taking AZA versus a group of women switching from MMF to AZA. |
Fischer-Betz Rheumatology (Oxford) 2013; 52:1070-6 10.1093/rheumatology/kes425 |
| Kociszewska-Najman, 2016 | inadequate or absent control group | EXCLUDED : Table 2 shows types of Infection in the newborns associated with the scheme of immunosuppression administered to pregnant women but if a women took more than one immunosuppressive drug she's counted in both groups, thus we can't compare groups. |
Kociszewska-Najman Transplant Proc 2016; 48:1556-60 10.1016/j.transproceed.2016.01.088 |
| Ong, 2021 | inadequate or absent control group | EXCLUDED : Absent group control. | |
| Ntali, 2022 | inadequate or absent control group | EXCLUDED : Absent group control. | |
| Thai, 2020 | inadequate or absent control group | EXCLUDED: comparison of Azathioprine versus mychophenolate (a well known teratogenic drug). => No adequate control group. |
Thai Pharmacoepidemiol Drug Saf 2020; 29:716-724 10.1002/pds.5017 Thai, T.N. Pharmacoepidemiol. Drug Saf. 2019; 28:30-. 10.1002/pds.4864 |
| Wang, 2019 | inadequate or absent control group | EXCLUDED: Comparison of women exposed to biologics (monotherapy or in combination with immunomodulator) compared to immunomodulator (IM) alone (azathioprine or 6-mercatopurine). => AZA in both group => No adequate control group. |
Wang, S. Gastroenterology 2019; 156:S-406-. 10.1016/S0016-5085(19)37866-7 |
| Coscia, 2014 | inadequate or absent control group | EXCLUDED: data provided for 'Azathioprine and/or Prednisone', without analysis for each treatment; and potential control groups may include azathioprine or mycophenolic acid products and/or prednisone => no adequate control group. |
Coscia Best Pract Res Clin Obstet Gynaecol 2014; 28:1174-87 10.1016/j.bpobgyn.2014.07.020 |
| Prentice, 2024 | inadequate or absent control group | EXCLUDED: Analysis of obstetric, hematological and biochemical outcomes in thiopurine versus biologic–exposed pregnancies, whose safety is unknown => no adequate control group. |
Prentice Inflamm Bowel Dis 2024; 30:2323-2334 10.1093/ibd/izae008 |
| Azzam, 2025 | other reason | EXCLUDED: One result provided for Anti-TNF agents and Azathioprine but OR and 95%CI are not consistent (14.6 (0.06-1.437)). |
Azzam, N. J. Crohn's Colitis 2025; 19:i1042-. 10.1093/ecco-jcc/jjae190.0678 |
| De Lima-Karagiannis, 2016 | not relevant exposure | EXCLUDED : Not relevant exposure. It studies effect of the activity of the disease on fetal outcome. No analysis about the impact of the treatment. |
de Lima-Karagiannis Am J Gastroenterol 2016; 111:1305-12 10.1038/ajg.2016.254 |
| Skorpen, 2018 | not relevant exposure | EXCLUDED: Analysis of the impact of illness and prednisolone but not hydroxychloroquine ('there were no significant differences in the use of hydroxychloroquine or azathioprine between the groups in any of the trimesters'). | |
| Al-Otaibi, 2019 | not relevant exposure | EXCLUDED : study aim to compare tacrolmus to cyclosporine, some women took azathioprine but there is no specific analysis. | |
| Malgarinos, 2007 | not relevant exposure | EXCLUDED : not relevant exposure. This study was not designed to evaluated the impact of AZA on birth outcomes. We chose not to built exposed/control groups within the IBD group, based on informations given in the publication. | |
| Cortes-Hernandez, 2002 | not relevant exposure | EXCLUDED: analysis of predictors of flare during pregnancy. Analysis of prednisone treatment impact on maternal or fetal outcomes but no analysis for azathioprine treatment. |
Cortés-Hernández 2002; 41:643-50 10.1093/rheumatology/41.6.643 |
| Lichtenstein, 2025 | not relevant exposure | EXCLUDED: Pregnancy outcomes only provided for certolizumab (investigation of association between lymphoma and the use of azathioprin not after pregnancy). |
Lichtenstein, G.R. Crohn's Colitis 360 2025; 7:S19-. 10.1093/crocol/otae083 |
| Azevedo, 1998 | not in pregnancy | EXCLUDED : Not in pregnancy. This study compares renal transplant in an SLE group and a non-SLE group. Pregnancy rates is one of the outcomes studied, but no details are given. | |
| Deepak, 2014 | not relevant study design | EXCLUDED :Data based on individual safety reports of adverse events from the Food and Drug Administration Adverse Event Reporting System. To many biais in this type of data sources. | |
| Magee, 2000 | not relevant outcome | EXCLUDED : Not relevant outcome. This study aim to examine erythropoiesis in renal transplant pregnancies. | |
| Fischer, 2005 | not relevant outcome | EXCLUDED : Not relevant outcome. This study show the effect of pregnancy on renal graft survival. | |
| Mountifield, 2010 | not relevant outcome | EXCLUDED : Not relevant outcome. Composite outcome "Major adverse event" = fetal malformations, low birth weight, preterm labour or any permanent defect or problem requiring ongoing management. | |
| Andrade, 2008 | not relevant outcome | EXCLUDED: analysis of treatments used before the pregnancy without information during the pregnancy (“these patients were not followed during their pregnancies. Thus we are unable to determine … continuity of treatment during pregnancy”). | |
| Yun, 2019 | not relevant outcome | EXCLUDED : not relevant outcome. The study aimed to compare success of clinical pregnancy in a group of women taking AZA versus a group of women taking deflazacort (glucorticoïdes). | |
| Reddy, 2008 | not relevant outcome | EXCLUDED : Not relevant outcome. In this case control study authors evaluated the risk of relapse of IBD during pregnancy. | |
| De Meije, 2013 | not relevant outcome | EXCLUDED : The scale used for the outocmes in this study is not validated. | |
| Tafreshian, 2025 | not relevant outcome | EXCLUDED: Adverse fetal outcomes included miscarriages, low birth weight, preterm labor, and fetal heart block => not a group of outcomes considered in metaPreg. |
Tafreshian, S. J. Obstet. Gynecol. India 2025; 75:287-. 10.1007/s13224-024-01974-w |
| Al Arfaj, 2010 | data not abstractable | EXCLUDED : Data from table 5 are not abstractable. | |
| Tandon, 2020 | data not abstractable | EXCLUDED: data not extractable: OR not provided by authors, nor the number of patients in the exposed and unexposed groups, nor the number of cases in each group (only % in each group). |
Tandon, P. J. Can. Ass. Gastroenterol. 2020; 3:320-. 10.1093/jcag/gwz047.243 |
| Mainbourg, 2023 | data not abstractable | EXCLUDED: Data not extractable ('In utero exposure to AZA was not associated with combined or specific neurodevelopmental disorders' => no quantitative results). |
Mainbourg, S. Birth Defects Res. 2023; 115:855-. 10.1002/bdr2.2181 |
| Norgard, 2007 | repeat population groups, duplicate reports (most recent study included) | EXCLUDED: For all outcomes, overlapping between Langagergaard 2007 and Norgard 2007. Data of Langagergaard 2007 were reported because it included more exposures (65 versus 20) and used a more relevant period of exposure for malformations (T1). |
Nørgård Am J Gastroenterol 2007; 102:1406-13 10.1111/j.1572-0241.2007.01216.x |
| Mahadevan, 2012 | repeat population groups, duplicate reports (most recent study included) | EXCLUDED : Most recent study included, Mahadevan 2021. | |
| Motta, 2007 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Study without separate analysis of the considered drug from other drugs (exposed=glucocorticoïdes /- immunosuppressant like azathioprine; controls=low dose aspirin). | |
| Candido, 2016 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Study without separate analysis of the considered drug from other drugs. | |
| Lima, 1995 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Not relevant exposure. It studied effect of lupus flares during pregnancy on fetal outcomes. There is no separate analysis of different drugs taken by the women during pregnancy. | |
| Many, 1992 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Study without separate analysis of the considered drug from other drugs. | |
| Palmsten, 2012 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of Disease-Modifying Antirheumatic Drug (DMARD) as a whole, without distinction between treatments. |
Palmsten Arthritis Care Res (Hoboken) 2012; 64:1730-8 10.1002/acr.21807 |
| Cararach, 1993 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Study without separate analysis of the considered drug from other drugs. | |
| Cooper, 2014 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Study without separate analysis of AZA from other immunosuppressive. | |
| Lichtenstein, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : "non biologic treatment" as a whole, no separate analysis. | |
| Buchanan, 1992 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : The study doesn't evaluate the impact of treatment but of the disease on pregnancy outcomes. |
Buchanan American journal of reproductive immunology; 28:192-4 10.1111/j.1600-0897.1992.tb00789.x |
| Schreiber-Zamora, 2014 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis performed on illness status, without distinction between treatments. |
Schreiber-Zamora 2014; 46:2798-801 10.1016/j.transproceed.2014.09.061 |
| Mohamed-Ahmed, 2014 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis performed on illness status, without distinction between treatments (most women took more than one immunoppressant drug). | |
| Pakhathirathien, 2021 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Table 3 shows pregnancy outcomes depending on treatment and activity of the disease but it's not possible to constitute a control group with corticosteroids as some women in corticosteroid group may also took azathioprine. |
Pakhathirathien J Trop Pediatr 2021; 67: 10.1093/tropej/fmab058 |
| Abisror, 2020 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : study without separate analysis for the considered drug from other drugs. | |
| Bortoli, 2011 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of immunomodulator therapy (azathioprine, cyclosporine, corticosteroids, infliximab) as a whole, without distinction between treatments. | |
| Gohr, 2022 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of maternal and foetal/neonatal adverse pregnancy outcomes according to illness, without distinction between treatments. | |
| Plauborg, 2016 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: AZA and corticosteroid exposures analysed as a whole (no separate analyse). |
Plauborg Birth Defects Res. Part A Clin. Mol. Teratol. 2016; 106:494-9 10.1002/bdra.23509 |
| Lever, 2022 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis performed on illness status, without distinction between treatments | |
| Chen, 2021 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: immunosuppressant (cyclosporin or azathioprine) studied as a whole without distinction between cyclosporin and azathioprine. | |
| Bar-Gil, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: conventional therapy (5-aminosalicylic acid agents and thiopurines) studied as a whole without distinction between treatments. |
Bar-Gil Shitrit Am J Gastroenterol 2019; 114:1172-1175 10.14309/ajg.0000000000000186 |
| Friedman, 2020 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of children born of women with illness versus women without illness, without distinction between treatments (included as cofounding factors). |
Friedman J Crohns Colitis 2020; 14:1709-1716 10.1093/ecco-jcc/jjaa106 |
| Venne, 2021 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Azathioprine, cyclosporine and sulfasalazine studied as a whole, without distinction between treatments. | |
| Hammami, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: for long-term outcomes: no distinction between treatments (other congenital anomalies reported in more details in Mahadevan 2021). |
Hammami, M.B. Gastroenterology 2019; 156:S-18-. 10.1016/S0016-5085(19)36817-9 |
| Ollech, 2021 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis of maternal and fetal outcomes according to study medications as a whole, without distinction. |
Ollech Clin Gastroenterol Hepatol 2021; 19:2444-2446.e2 10.1016/j.cgh.2020.10.035 |
| Julkunen, 1994 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Study without separate analysis of the considered drug. | |
| Abdwani, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: women with SLE analyzed as a whole, without distinction between treatments (Hydroxychloroquine, azathioprine or prednisolone). | |
| Bar, 2003 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis performed on illness status, without distinction between treatments |
Bar Am. J. Med. Genet. A 2003; 116A:31-6 10.1002/ajmg.a.10817 |
| Rajaei, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Study without separate analysis of the considered drug from other drugs. | |
| Ammouri, 2024 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancy outcomes provided for pregnancies whatever treatment. |
Ammouri, W. Ann. Rheum. Dis. 2024; 83:1902-. 10.1136/annrheumdis-2024-eular.6019 |
| Bedin, 2022 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancy outcomes provided for pregnancies whatever treatment. | |
| Barros, 2022 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancy outcomes provided for pregnancies whatever treatment. |
Barros, T. Reumatologia 2022; 60:311-. 10.5114/reum.2022.120754 |
| Avni Biron, 2023 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancies outcomes provided according to illness, whatever treatment. | |
| Coscia, 2025 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancies outcomes provided whatever treatment. |
Coscia, L.A. J. Heart Lung Transplant. 2025; 44:S19-. 10.1016/j.healun.2025.02.044 |
| Jakobsen, 2024 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancies outcomes provided whatever treatment. |
Jakobsen, B. Ann. Rheum. Dis. 2024; 83:383-. 10.1136/annrheumdis-2024-eular.1205 |
| Yeo, 2025 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancies outcomes provided whatever treatment. |
Yeo, J.H. J. Crohn's Colitis 2025; 19:i699-. 10.1093/ecco-jcc/jjae190.0439 |
| Da Costa, 2024 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancies outcomes provided whatever treatment. |
Da Costa, J.O. Nephrol. Dial. Transplant. 2024; 39:i2089-. 10.1093/ndt/gfae069.1293 |
| Avni-Biron, 2022 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: non-anti-TNF agents studied as a whole, without distinction between treatments. |
Avni-Biron Aliment Pharmacol Ther 2022; 56:1361-1369 10.1111/apt.17224 |
| Lopes, 2023 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancies outcomes provided whatever treatment. |
Lopes, A.R. Ann. Rheum. Dis. 2023; 82:647-. 10.1136/annrheumdis-2023-eular.1772 |
| Ozturk, 2025 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancies outcomes provided whatever treatment. |
Ozturk, O. J. Crohn's Colitis 2025; 19:i1154-. 10.1093/ecco-jcc/jjae190.0751 |
| Huong, 2001 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Study without separate analysis of the considered drug from other drugs. In this study only one woman was treated with AZA and there is no separate analysis from other women. | |
| Elahi, 2024 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Analysis of pregnancy outcomes according to illness, without distinction between treatments. | |
| Driouch, 2023 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Analysis of pregnancy outcomes according to illness, without distinction between treatments. | |
| Czeizel, 2004 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : No separated analysis for the considered drug. | |
| Budtarad, 2025 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Analysis of pregnancy outcomes according to illness, without distinction between treatments. | |
| Gaughan, 1996 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Study without separate analysis of the considered drug from other drugs. | |
| El Houssni, 2016 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED : Study without separate analysis of the considered drug from other drugs. | |
| Lopes, 2024 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Pregnancies outcomes provided whatever treatment. |
Lopes, A.R. Ann. Rheum. Dis. 2024; 83:2134-. 10.1136/annrheumdis-2024-eular.3296 |
| Norgard, 2011 | Review articles, letter to editor, editorial, comments | EXCLUDED : This article is a thesis which regroups 8 studies. This studies are either inrelevant (not relevant exposure) or already included in another study. | |
| Friedman, 2007 | Review articles, letter to editor, editorial, comments | EXCLUDED : Review article. |
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