| Study | Exclusion reasons | Rmk | Reference |
|---|---|---|---|
| Williams, 0 | |||
| Wyroba, 2014 | inadequate or absent control group | ||
| Martín, 2014 | inadequate or absent control group | EXCLUDED: Unadequate control group as the one with women exposed to MTX only before conception, at best, received the last dose at 3.5 months before conception. |
Martín Reprod Toxicol 2014; 43:26-9 10.1016/j.reprotox.2013.10.005 |
| Lok, 2003 | inadequate or absent control group | ||
| Keefe, 1998 | inadequate or absent control group | EXCLUDED: No control group for the subsequent pregnancies in women who have been treated with methotrexate for tubal pregnancies and no distinction of the period of exposure. | |
| Goto, 2004 | inadequate or absent control group | EXCLUDED: Authors examined the cohort of children born to women who were treated with combined chemotherapy for possible abnormalities. Without comparison with a control group. |
Goto Gynecol Oncol 2004; 93:529-35 10.1016/j.ygyno.2004.02.018 |
| Giacalone, 1999 | inadequate or absent control group | EXCLUDED: They report the results of 20 patients who had undergone chemotherapy during pregnancy. It's a case-report design without a control group. | |
| Blagden, 2002 | inadequate or absent control group | EXCLUDED: No control group, the other group is the ‘multi-agent’ group composed of those with medium or high-risk disease requiring treatment with either MTX/FA plus actinomycin D or combination drug chemotherapy (with MTX). | |
| Beksac, 2017 | inadequate or absent control group | EXCLUDED: Case-report with the use of chemotherapy during pregnancy.13 patients undergoing chemotherapy during their current pregnancy were evaluated but not compared. | |
| Danet, 2018 | inadequate or absent control group | EXCLUDED: Because the objective of the study was to describe pregnancy outcomes of pregnant women exposed to cancer chemotherapy. This is not a comparative study, there isn't an adequate control group. |
Danet Pharmacoepidemiol Drug Saf 2018; 27:1302-1308 10.1002/pds.4689 |
| Braga, 2009 | inadequate or absent control group | EXCLUDED: no adequate control group and exposure, they compared low-risk GTN patients administered a single agent regimen (methotrexate or actinomycin D) with high-risk GTN patients who received multiagent chemotherapy (including methotrexate). |
Braga Gynecol Oncol 2009; 112:568-71 10.1016/j.ygyno.2008.10.027 |
| Lewden, 2004 | inadequate or absent control group | EXCLUDED: No control group and all women were exposed post-conception. | |
| Ring, 2005 | case report or case series | EXCLUDED: Retrospective case series concerning the use of chemotherapy for breast cancer during pregnancy. | |
| Bakula, 2016 | case report or case series | EXCLUDED: It's a case report 'We present a patient with rheumatoid arthritis whose pregnancy was discovered at 31 weeks of gestation.' | |
| Donoway, 2012 | case report or case series | ||
| Na, 2018 | case report or case series | EXCLUDED: A retrospective study of medical records. The purpose of this study was to evaluate the clinical characteristics of patients with Heterotopic pregnancy (HP), the risk factors of miscarriage of intrauterine pregnancy after the treatment of HP. |
Na Medicine (Baltimore) 2018; 97:e12233 10.1097/MD.0000000000012233 |
| Upponi, 2003 | review, editorial, news or commentary | EXCLUDED: This paper reviews the literature using Medline and Embase databases. |
Upponi Eur J Cancer 2003; 39:736-41 10.1016/s0959-8049(02)00870-5 |
| Ramsey-Goldman (Pre-conception) (Controls unexposed, sick), 1993 | not relevant exposure | EXCLUDED: Not relevant exposure because of the study's aim. | |
| Brouwer (Pre-conception), 2015 | not relevant exposure | EXCLUDED: Not relevant exposure because patients were required to have stopped methotrexate (MTX) at least 3 months before trying to conceive so some may not have been exposed for a long time. |
Brouwer Arthritis Rheumatol 2015; 67:1738-43 10.1002/art.39137 |
| Lee, 2010 | not relevant exposure | EXCLUDED: Paternal drug exposure at the time of conception. |
Lee Reprod Toxicol 2010; 29:353-60 10.1016/j.reprotox.2010.01.008 |
| Ulbricht, 2003 | not relevant exposure | EXCLUDED: a Chaparral monograph (a plant), not about methotrexate. |
Ulbricht, C. Journal of Herbal Pharmacotherapy 2003; 3:121-. 10.1080/J157v03n01_08 |
| Belli, 2009 | not relevant exposure | EXCLUDED: Genetic Counseling for Teratogenic Risk Due To Exposure to Medications: 89 Pregnancies Conceived During Oral Contraceptive Use. |
Belli Am J Med Genet A 2009; 149A:1555-7 10.1002/ajmg.a.32608 |
| De Lorenzo, 2020 | not relevant exposure | EXCLUDED: Exposure to Biologic disease-modifying anti-rheumatic drugs (bDMARDs) during pregnancy. No useof MTX mentionned in the cohort. |
De Lorenzo Pharmacol Res 2020; 152:104583 10.1016/j.phrs.2019.104583 |
| Bengtson, 2010 | not relevant exposure | EXCLUDED: The aim of the study is to explore the influence of maternal and paternal IBD (inflammatory bowel disease) on perinatal outcomes in the offspring and the risk for development of IBD. Immunomodulatory therapy is mentioned but not studied. |
Bengtson, M.-B. Inflammatory Bowel Diseases 2010; 16:847-. 10.1002/ibd.21120 |
| Uberti, 2015 | not in pregnancy | EXCLUDED: : To compare two single-agent chemotherapy (ChT) regimens evaluating, in first-line treatment, response and side effects and, in final single-agent treatment, the outcomes. |
Uberti Rev Bras Ginecol Obstet 2015; 37:258-65 10.1590/SO100-720320150005366 |
| Beghin, 2011 | not in pregnancy | EXCLUDED: Paternal exposure to methotrexate (MTX) at the time of conception. | |
| Kenney, 1996 | not in pregnancy | EXCLUDED: Study to determine if offspring of adults (males and females) successfully treated for childhood acute lymphoblastic leukemia had an increased incidence of birth defects (involves offspring given birth to or fathered). |
Kenney Cancer 1996; 78:169-76 10.1002/(SICI)1097-0142(19960701)78:1<169::AID-CNCR23>3.0.CO;2-X |
| Kim, 2004 | not in pregnancy | EXCLUDED: To evaluate the changing epidemiologic picture and clinical characteristics of gestational trophoblastic disease (GTD). No mention of subsequent pregnancy outcomes. | |
| Lindström, 2016 | not in pregnancy | EXCLUDED: The purpose of this study was to determine whether perinatal characteristics predict development of ankylosing spondylitis (AS). Fetal exposure is not considered. |
Lindström Arthritis Res Ther 2016; 18:16 10.1186/s13075-016-0917-1 |
| Hyman, 2013 | not in pregnancy | EXCLUDED: The goal was to describe presentation, management, and natural history of Placental site trophoblastic tumors (PSTTs) and to identify important prognostic features in this cohort. Not about pregnancy. |
Hyman Gynecol Oncol 2013; 129:58-62 10.1016/j.ygyno.2012.12.029 |
| Gibofsky, 2011 | not in pregnancy | EXCLUDED: Patients were excluded from participation in both registries if they were currently enrolled in a clinical trial with treatments or patient visits imposed by a protocol, nursing or pregnant. | |
| Choon, 2014 | not about fetal exposure | EXLUDED: The objective of this study is to analyze the clinical profile of 102 patients with adult-onset Generalized pustular psoriasis (GPP). Not about fetal exposure. | |
| Hellwig, 2010 | not about fetal exposure | EXCLUDED: This study aimed at investigating the effect of multiple sclerosis (MS)-fathers under disease modifying therapies (DMT) on pregnancy. | |
| Eck, 2017 | not about fetal exposure | EXCLUDED: Paternal Exposure to Methotrexate Within 90 Days Before Pregnancy. |
Eck Obstet Gynecol 2017; 129:707-714 10.1097/AOG.0000000000001936 |
| Engeland, 2013 | not about fetal exposure | EXCLUDED: They aimed to explore associations between drugs dispensed to the father prior to conception and pregnancy outcomes. |
Engeland Br J Clin Pharmacol 2013; 75:1134-41 10.1111/j.1365-2125.2012.04426.x |
| Perez-Garcia, 2020 | not about fetal exposure | EXCLUDED: Review the literature for the influence of paternal immunosuppressive drug use on many aspects of male sexual health, such as sexual function, fertility, pregnancy outcomes and offspring health outcomes. |
Perez-Garcia Hum Reprod Update 2020; 26:961-1001 10.1093/humupd/dmaa022 |
| Zakhem, 2019 | not about fetal exposure | EXCLUDED: Systematic review to assess whether systemic dermatologic medications can cause infertility and teratogenicity when taken by men. |
Zakhem J Am Acad Dermatol 2019; 80:957-969 10.1016/j.jaad.2018.09.031 |
| Cardonick, 2010 | not relevant study design | EXCLUDED: This article discusses the presentation and treatment of pregnant women with cancer, the pregnancy outcomes, and longterm follow-up for the child exposed to chemotherapy in utero. Not an observational study design. |
Cardonick Am J Clin Oncol 2010; 33:221-8 10.1097/COC.0b013e3181a44ca9 |
| Czeizel, 2004 | not relevant study design | EXCLUDED: The objectives of this paper are to describe the Hungarian case–control surveillance system of congenital abnormalities (HCCSCA). | |
| Durrieu, 2004 | not relevant study design | EXCLUDED: Descriptive analysis of medical data and pregnancy outcome was performed. 2 women exposed to methotrexate in polytherapy. Not a comparative study. |
Durrieu Fundam Clin Pharmacol 2004; 18:573-9 10.1111/j.1472-8206.2004.00267.x |
| Zhu, 2019 | not relevant study design | EXCLUDED: Aimed to evaluate the efficacy and toxicity of VMP regimen applied to the patients with low-risk gestational trophoblastic neoplasia. During follow-up some patients became pregnant but there isn't a control group. |
Zhu Taiwan J Obstet Gynecol 2019; 58:332-337 10.1016/j.tjog.2019.03.008 |
| Nörby, 2013 | not relevant study design | EXCLUDED: The purpose is to present concept, methods and use of a knowledge database providing assessments of potential fetal risks for all drugs on the Swedish market. |
Nörby Eur J Clin Pharmacol 2013; 69:889-99 10.1007/s00228-012-1399-y |
| Cyrulnik, 2010 | not relevant study design | EXCLUDED: Specific dermatoses of pregnancy with an overview of the current state of care, not an observational study. | |
| Tisonová, 2006 | not relevant study design | ||
| Peres (Controls unexposed, sick), 2001 | not relevant study design | EXCLUDED: Not relevant exposure because of the study's aim. |
Peres Braz J Med Biol Res 2001; 34:1551-9 10.1590/s0100-879x2001001200007 |
| Chiheb, 2003 | not relevant study design | EXCLUDED: Continuing Medical Education material on behçet's disease, not an observational study. | |
| Rebic, 2020 | not relevant outcome | EXCLUDED: They aimed to characterize the utilization and discontinuation of medications before, during and after pregnancy among women with rheumatoid arthritis. No relevant outcome regarding pregnany or offspring. |
Rebic Rheumatology (Oxford) 2020; 59:1514-1521 10.1093/rheumatology/kez478 |
| Tidy, 1995 | not relevant outcome | EXCLUDED: Retrospective analysis of case records in management of choriocarcinoma after nonmolar pregnancy. |
Tidy Br J Obstet Gynaecol 1995; 102:715-9 10.1111/j.1471-0528.1995.tb11429.x |
| Palmsten, 2017 | not relevant outcome | EXCLUDED: The aim was to characterize SLE medication trends before, during and after pregnancy. No relevant outcome regarding pregnany or offspring. |
Palmsten Rheumatology (Oxford) 2017; 56:561-569 10.1093/rheumatology/kew448 |
| Olofsson, 2001 | not relevant outcome | EXCLUDED: The aim of the present study was to investigate the effectiveness of methotrexate treatment in routine clinical practice (eliminate ectopic pregnancy without surgical intervention). |
Olofsson Acta Obstet Gynecol Scand 2001; 80:744-9 10.1034/j.1600-0412.2001.080008744.x |
| Guvendag, 2010 | not relevant outcome | EXCLUDED: Compare the success rates of single and multiple dose methotrexate protocols for the treatment of unruptured tubal ectopic pregnancy. |
Guvendag Guven Acta Obstet Gynecol Scand 2010; 89:889-95 10.3109/00016349.2010.486825 |
| Kuriya, 2011 | not relevant outcome | EXCLUDED: The aim of this study was to address the gap in knowledge of how pregnant women with rheumatoid arthritis are treated in daily clinical practice. |
Kuriya Arthritis Care Res (Hoboken) 2011; 63:721-8 10.1002/acr.20422 |
| Uyar, 2013 | not relevant outcome | EXCLUDED: To evaluate ovarian reserve in women with ectopic pregnancy treated with single-dose systemic methotrexate. Main outcomes are Basal FSH on the 3rd day of the menstrual cycle, E2, basal antral follicle count (AFC), and ovarian volume. |
Uyar Fertil Steril 2013; 100:1310-3 10.1016/j.fertnstert.2013.06.040 |
| Tzouma, 2015 | article unavailable | EXCLUDED: article unavailable. |
Tzouma, V. Therapeutic Innovation and Regulatory Science 2015; 49:947-. 10.1177/2168479015589820 |
| Lagarce, 2016 | non English publications | EXCLUDED: no control group available 'expected in the general population'. No period of exposure distinction. |
Lagarce Therapie 2016; 71:389-94 10.1016/j.therap.2015.12.005 |
| Drechsel, 2020 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to DMARD as a whole, with specific data only for TNF and Etanercept but not for other treatments. |
Drechsel Rheumatology (Oxford) 2020; 59:603-612 10.1093/rheumatology/kez309 |
| Abisror, 2020 | Studies without separate analysis of the considered drug/class from other drugs/class |
Abisror Clin Rheumatol 2020; 39:2707-2713 10.1007/s10067-020-05024-4 |
|
| Abdulrahman,, 2020 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Because outcomes are not evaluated depending on treatments exposure. But a significant correlation was established between pre-conceptional use of MTX and thenumber of abortions (r = 0.164, p = 0.02). |
Abdulrahman, M.A. Egyptian Rheumatologist 2020; 42:83-. 10.1016/j.ejr.2019.11.001 |
| Vinet, 2015 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis according to illness without distinction between treatments (just 'immunosuppressives in utero exposure'). | |
| Tedeschi, 2016 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Analysis of impact of illness during pregnancy on pregnancy outcomes. |
Tedeschi Clin Rheumatol 2016; 35:1725-32 10.1007/s10067-016-3270-5 |
| Cardonick, 2015 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Cognitive and behavioral outcomes for children exposed in utero to chemotherapy born to mothers with cancer diagnoses. No distinction according to chemotherapy. |
Cardonick Am J Obstet Gynecol 2015; 212:658.e1-8 10.1016/j.ajog.2014.11.032 |
| Sangle, 2015 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: aimed to study the outcome of pregnancy in patients with systemic vasculitis (SV) compared with healthy pregnant controls. There is no further description of the 6 patients who received MTX discontinued before conception. |
Sangle Rheumatology (Oxford) 2015; 54:1582-6 10.1093/rheumatology/kev018 |
| Stokkeland, 2016 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: The aim of this study was to investigate the risks of pregnancy and childbirth complications in women with autoimmune hepatitis compared to the population controls. Outcomes are investigated according to groups of drugs. | |
| Matsui, 2004 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: They assess outcomes of pregnancies occuring after various waiting periods after chemotherapy without distinction. Some patients are not even exposed to MTX. | |
| Matok, 2009 | Studies without separate analysis of the considered drug/class from other drugs/class |
Matok Br J Clin Pharmacol 2009; 68:956-62 10.1111/j.1365-2125.2009.03544.x |
|
| Lichtenstein, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class |
Lichtenstein Am J Gastroenterol 2018; 113:1678-1688 10.1038/s41395-018-0202-9 |
|
| Kim (preconception), 2008 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Analysis according to maternal illness (Lupus), without distinction between treatments. One methotrexate exposure is mentioned but the outcomes (Apgar and growth) are unknown other than 'the neonate did not exhibit any fetal abnormality'. |
Kim Yonsei Med. J. 2008; 49:515-20 10.3349/ymj.2008.49.4.515 |
| Langen, 2014 | Studies without separate analysis of the considered drug/class from other drugs/class | ||
| Levy, 2012 | Studies without separate analysis of the considered drug/class from other drugs/class |
Levy J Clin Pharmacol 2012; 52:78-83 10.1177/0091270010390806 |
|
| Lin, 2014 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Immunosuppressants use without drug distinction (cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, ciclosporin and tacrolimus). |
Lin, P. Lupus Science and Medicine 2014; 1:199-. 10.1136/lupus-2014-000024 |
| La, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class |
La Nasa Am J Clin Oncol 2019; 42:351-354 10.1097/COC.0000000000000527 |
|
| Hamann, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Group of exposure 'Use of systemic non-corticosteroid immunomodulators' without distinction of methotrexate. |
Hamann J Eur Acad Dermatol Venereol 2019; 33:577-587 10.1111/jdv.15256 |
| Gziri, 2013 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Methotrexate exposure not studied separately. Children were exposed to anthracyclines alone or with other chemotherapeutic agents (cisplatinum, 5-fluorouracil, cyclophosphamide, methotrexate, etoposide, bleomycine, ...). |
Gziri Eur J Pediatr 2013; 172:163-70 10.1007/s00431-012-1849-7 |
| Chakravarty, 2005 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: The purpose of this study was to describe the outcomes of a cohort of pregnancies in patients with systemic lupus erythematosus. 2 patients were receiving methotrexate without more details. |
Chakravarty Am J Obstet Gynecol 2005; 192:1897-904 10.1016/j.ajog.2005.02.063 |
| de Man, 2009 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: 77 women had ever used methotrexate before pregnancy but no data of the outcomes of these pregnancies. Analysis performed for all pregnancies (whatever the treatments) and for prednisone. | |
| Van Clasteren, 2010 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Prenatal-exposed group included all infants exposed to Chemotherapy (with or without surgery or radiotherapy) during pregnancy, without distinction between chemotherapy regimens. |
Van Calsteren J. Clin. Oncol. 2010; 28:683-9 10.1200/JCO.2009.23.2801 |
| Hyrich, 2006 | Review articles, letter to editor, editorial, comments | EXCLUDED: Pregnancy outcomes of the 9 pregnant women exposed to MTX not reported. | |
| Lin, 2015 | Review articles, letter to editor, editorial, comments | ||
| Pautier, 2004 | Review articles, letter to editor, editorial, comments | EXCLUDED: Comments, Cancer and pregnancy: the medical oncologist’s point of view. |
Pautier J Gynecol Obstet Biol Reprod (Paris) 2004; 33:S23-8 10.1016/s0368-2315(04)96660-4 |
| Uhl, 2004 | Review articles, letter to editor, editorial, comments | ||
| Taylor, 2008 | Review articles, letter to editor, editorial, comments | ||
| Vinet, 2009 | Review articles, letter to editor, editorial, comments | EXCLUDED: Autors performed a systematic literature review. | |
| Florea, 2008 | Review articles, letter to editor, editorial, comments | EXCLUDED for litterature review. |
Florea Presse Med 2008; 37:1644-51 10.1016/j.lpm.2008.06.015 |
| Braunstein, 2013 | Review articles, letter to editor, editorial, comments | EXCLUDED: Here we will summarize the data available for the safety and efficacy in pregnancy and lactation of the main immunomodulatory andimmunosuppressive agents used to treat autoimmune cutaneous conditions. | |
| Koren, 2013 | Review articles, letter to editor, editorial, comments | EXCLUDED: It's a clinical practice guideline to develop clinical recommendations for the use of cancer chemotherapy in pregnant women and women of child-bearing age. Only quoted studies. |
Koren, G. Journal of Obstetrics and Gynaecology Canada 2013; 35:263-. 10.1016/S1701-2163(15)30999-3 |
| Hackmon, 2011 | Review articles, letter to editor, editorial, comments | ||
| Del Pup, 2012 | Review articles, letter to editor, editorial, comments | EXCLUDED: This article reviews the available data regarding the different aspects of systemic treatment of cancer during pregnancy. |
Del Pup Int J Immunopathol Pharmacol ; 25:33S-46S 10.1177/03946320120250s203 |
| Biedermann, 2012 | Review articles, letter to editor, editorial, comments | EXCLUDED: This article, consistent with the European Crohn’s and Colitis Organization (ECCO) guidelines, reviews the literature. |
Biedermann Digestion 2012; 86 Suppl 1:45-54 10.1159/000341941 |
| Ostensen, 2001 | Review articles, letter to editor, editorial, comments | EXCLUDED: Not an original study. |
Ostensen Best Pract Res Clin Obstet Gynaecol 2001; 15:953-69 10.1053/beog.2001.0240 |
| Heetun, 2007 | Review articles, letter to editor, editorial, comments | EXCLUDED: Review the best management of Inflammatory bowel disease (IBD) in the reproductive and pregnant population. |
Heetun Aliment Pharmacol Ther 2007; 26:513-33 10.1111/j.1365-2036.2007.03397.x |
| Park, 2017 | Review articles, letter to editor, editorial, comments |
Park Eur J Obstet Gynecol Reprod Biol 2017; 212:192-193 10.1016/j.ejogrb.2017.02.018 |
|
| Hyoun, 2012 | Review articles, letter to editor, editorial, comments | EXCLUDED: Review on 'Teratogen Update: Methotrexate'. |
Hyoun Birth Defects Res A Clin Mol Teratol 2012; 94:187-207 10.1002/bdra.23003 |
| Draycott, 1997 | Review articles, letter to editor, editorial, comments | ||
| Evens, 2013 | pattern of exposure | ||
| Loibl, 2012 | pattern of exposure |
Loibl Lancet Oncol 2012; 13:887-96 10.1016/S1470-2045(12)70261-9 |
|
| Viktil, 2009 | pattern of exposure | EXCLUDED: Pattern of exposure without data on fetal/maternal/neonatal safety outcomes 'The aim of this study was to explore the use of antirheumatic drugs among both pregnant women and expectant fathers in Norway'. |
Viktil KK Pharmacoepidemiol Drug Saf 2009;18:737-42 10.1002/pds.1775 |
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