| Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
|---|---|---|---|---|---|---|
| Abd Rahman, 2020 |
Malaysia 2007 - 2017 |
Pregnant women with Systemic Lupus Erythematosus (SLE) had antenatal management and deliveries in the tertiary center. | Hydroxychloroquine (HCQ) use during pregnancy in Systemic Lupus Erythematosus (SLE) patients. |
unexposed, sick
No hydroxychloroquine (HCQ) use during pregnancy in Systemic Lupus Erythematosus (SLE) patients. |
47 / 35 | |
| Al Arfaj, 2010 |
Saudi Arabia 1980 - 2006 |
All pregnancies in patients with Systemic lupus erythematosus (SLE) managed at King Khalid University Hospital, Riyadh. | Pregnancies exposed to prednisolone and hydroxychloroquine. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnancies exposed to prednisolone only. (This is a subgroup of exposure among the whole exposed group considered in the study). |
69 / 222 | The group of exposure 'None' was defined as 'All medications were discontinued upon confirmation of pregnancy' => Due to the long half-life of HCQ it cannot be used as unexposed group. The same for the group 'HCQ stopped' before pregnancy. |
| Andersson (Controls exposed to corticosteroides), 2021 |
Denmark 1996 - 2016 |
All live birth pregnancies in Denmark identified via the Medical Birth Registry. | Pregnant women with a filled prescription for hydroxychloroquine during the considered time windows of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women with a filled prescription for oral Glucocorticoids (H02AB) during the considered time windows of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
293 / 293 | The medians for number of redeemed tablets and tablet strengths were 40 tablets (IQR, 20–40) and 250 mg (IQR, 250–250) for chloroquine and 100 tablets (IQR, 100–100) and 200 mg (IQR, 200–250) for hydroxychloroquine. |
| Andersson (Controls unexposed, NOS), 2021 |
Denmark 1996 - 2016 |
All live birth pregnancies in Denmark identified via the Medical Birth Registry. | Pregnant women with a filled prescription for hydroxychloroquine during the considered time windows of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women with no filled prescriptions for a 4-aminoquinoline drug (i.e chloroquine or hydroxychloroquine) during the respective pregnancy-exposure time windows as well as in the 6 months prior to pregnancy onset. |
303 / 303 | The medians for number of redeemed tablets and tablet strengths were 40 tablets (IQR, 20–40) and 250 mg (IQR, 250–250) for chloroquine and 100 tablets (IQR, 100–100) and 200 mg (IQR, 200–250) for hydroxychloroquine. |
| Baalbaki, 2020 |
USA 2006 - 2013 |
All patients with Systemic Lupus Erythematosus (SLE) and a singleton gestation who delivered at the institution. | Pregnant patients with Systemic Lupus Erythematosus (SLE) treated with Hydroxychloroquine during pregnancy. |
unexposed, sick
Pregnant patients with Systemic Lupus Erythematosus (SLE) not treated with Hydroxychloroquine during pregnancy. |
47 / 30 | Patients with multifetal gestations and prenatally diagnosed congenital anomalies were excluded. In addition, patients with confirmed antiphospholipid syndrome and on anticoagulation were also excluded. |
| Buchanan, 1996 |
United Kingdom Not specified |
Patients with systemic lupus erythematosus (SLE) or related conditions who attended this clinic during pregnancy. | Pregnancies who had attended the clinic with lupus pregnancy and who had taken hydroxychloroquine (HCQ). |
unexposed, sick
Pregnancies who had attended the clinic with lupus pregnancy were drawn randomly from the same database. |
36 / 53 | 22 were exposed to HCQ 200mg/day and 14 to 400 mg/day at some point during gestation. Mean duration of HCQ in pregnancy: 28.4weeks. Total overlapping between Khamashta 1996 and Buchanan 1996, with some additional outcomes in Buchanan 1996 (=> kept). |
| Canti, 2021 |
Italy 2003 - 2019 |
Pregnancies in women with systemic lupus erythematosus (SLE) | Pregnancies in women with systemic lupus erythematosus (SLE) treated with hydroxychloroquine (HCQ). |
unexposed, sick
Pregnancies in women with systemic lupus erythematosus (SLE) who did not receive hydroxychloroquine (HCQ). |
45 / 29 | HCQ: 300mg/day throughout pregnancy. Treatment with corticosteroids, low dose aspirin, and low molecular weight heparin during pregnancy was similar in the two groups (with higher dose of prednisolone in HCQ-). AZA in 21% unexposed and 40% in HCQ. |
| Chakravarty, 2005 |
USA 1991 - 2001 |
All the pregnant patients with Systemic lupus erythematosus (SLE) who were seen at the Hospital. | Pregnant patients with Systemic lupus erythematosus (SLE) that received hydroxychloroquine. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant patients with Systemic lupus erythematosus (SLE) that not received hydroxychloroquine. (This is a subgroup of exposure among the whole exposed group considered in the study). |
13 / 50 | 21% of the patients were taking hydroxychloroquine (mean dose, 364 mg daily). |
| Chambers (Controls unexposed, disease free), 2022 |
Canada and USA 2004 - 2018 |
Pregnant women or their health care providers who contact the services with questions about the risks of exposures in pregnancy. | Women with diagnoses of various autoimmune diseases exposed to hydroxychloroquine at any dose and for any indication from the first day of the last menstrual period to the end of pregnancy. |
unexposed, disease free
Healthy women without autoimmune diseases (and no hydroxychloroquine during pregnancy). |
279 / 279 | The average daily dose of HCQ per treatment week was 324.8 mg per day, with a range of 100 mg to 800 mg per day. |
| Chambers (Controls unexposed, sick), 2022 |
Canada and USA 2004 - 2018 |
Pregnant women or their health care providers who contact the services with questions about the risks of exposures in pregnancy. | Women with diagnoses of various autoimmune diseases exposed to hydroxychloroquine at any dose and for any indication from the first day of the last menstrual period to the end of pregnancy. |
unexposed, sick
Women with diagnoses of various autoimmune diseases not exposed to hydroxychloroquine at any time during pregnancy. |
279 / 279 | The average daily dose of HCQ per treatment week was 324.8 mg per day, with a range of 100 mg to 800 mg per day. |
| Cimaz, 2007 |
Italy 1999 - 2000 |
Babies born from mothers who were followed in two pregnancy autoimmune centers, with primary antiphospholipid syndrome, systemic lupus erythematosus (SLE), Sjogren’s syndrome or connective tissue disease. | Babies born from patients receiving Hydroxychloroquine (alone or in association) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Babies born from patients who did not receive immunosuppressants during pregnancy and take low-dose aspirin during pregnancy. |
14 / 6 | |
| Clowse, 2006 |
USA 1987 - 2002 |
Consecutive pregnant women with systemic lupus erythematosus (SLE) seen in this Center. | Pregnant women with systemic lupus erythematosus (SLE) with Hydroxychloroquine (HCQ) throughout pregnancy. |
unexposed, sick
Pregnant women with systemic lupus erythematosus (SLE) without hydroxychloroquine (HCQ) within the 3 months prior to or during pregnancy. |
56 / 163 | Similar rates of azathioprine and prednisolone use among women who took HCQ and those who never took HCQ. Due to long half-life of HCQ, the group who stopped HCQ before or during 1st trimester of pregnancy cannot be considered as unexposed to HCQ. |
| Colvin, 2010 |
Australia 2002 - 2005 |
All birth events in Western Australia (WA). | Hydroxychloroquine dispensed from 14 days after the last menstrual period (LMP) to the end of first trimester or to the end of the pregnancy event. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
All other births (those births to women dispensed a Pharmaceutical Benefits Scheme (PBS) medicine or not). |
26 / 106048 | Category D or X medicines also studied. Total nb of unexposed: 106048=106 074-26. Birth defect: structural or functional abnormality. Most minor defects are not recorded in the BDR. Of all cases, about 90% have at least one major birth defect. |
| Cooper (controls exposed to TNF-I), 2014 |
USA 1995 - 2007 |
Women with inflammatory arthropathies, systemic lupus erythematosus, and inflammatory bowel disease who filled prescriptions for immunosuppressive or corticosteroids during pregnancy. | Prescription for hydroxychloroquine (in the absence of methotrexate or TNF-I fetal exposure) during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Prescription for tumor necrosis factor inhibitors (TNF-I) (in the absence of methotrexate or hydroxychloroquine fetal exposure) during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
194 / 56 | Births in which the mother received prescriptions during the first trimester for medications thought to be teratogenic (valproic acid, chemotherapy medications, lithium misoprostol, and warfarin) were excluded. |
| Cooper (controls unexposed, sick), 2014 |
USA 1995 - 2007 |
Women with inflammatory arthropathies, Systemic lupus erythematosus, and inflammatory bowel disease who filled prescriptions for immunosuppressive or corticosteroids during pregnancy. | Pregnant women with immune-mediated diseases with prescription for hydroxychloroquine (in the absence of methotrexate or TNF-I fetal exposure) during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with immune-mediated diseases treated with immunosuppressive medications in the 180 days before, but not during, pregnancy. |
194 / 171 | Births in which the mother received prescriptions during the first trimester for medications thought to be teratogenic (valproic acid, chemotherapy medications, lithium misoprostol, and warfarin) were excluded. |
| Costedoat-Chalumeau, 2003 |
France 1993 - 2002 |
Pregnant women with systemic lupus erythematosus (SLE), connective tissue disease (CTD), Sjogren’s syndrome, antiphospholipid syndrome, who had been monitored regularly at the Pitié-Salpétrière Hospital before becoming pregnant. | Pregnancies in women treated with Hydroxychloroquine (HCQ) continued throughout gestation (and at least 6 months prior to pregnancy). |
unexposed, sick
Pregnancies in women who had not been treated with HCQ for at least 6 months prior to conception. |
133 / 70 | Women received HCQ 200 mg twice daily (122 pregnancies), or HCQ 200 mg once daily (11 pregnancies). Other treatments (in HCQ exposed and unexposed groups) included prednisone, aspirin 100 mg/day, LMW heparin, AZA, and iv immunoglobulin. |
| Diav-Citrin, 2013 |
Israel 1998 - 2006 |
Women who contacted the Israeli Teratology Information Service (TIS). | Pregnant women exposed to hydroxychloroquine (HCQ). |
unexposed (general population or NOS)
Pregnant women exposed to agents known not to be teratogenic. |
114 / 455 | Additional medications for the rheumatic disease were taken in 79.8% of the HCQ group. The median daily dose [interquartile range (IQR) between the 25 and 75th percentiles] of HCQ was 300 mg (200–400). |
| Do, 2020 |
USA 2000 - 2017 |
Pregnant women with Systemic lupus erythematosus (SLE) aged 18 years or older who delivered after 20 weeks at Lucile Packard Children’s Hospital at Stanford. | Hydroxychloroquine (HCQ)-exposed pregnancies. |
unexposed, sick
Hydroxychloroquine (HCQ)-unexposed pregnancies. |
53 / 76 | |
| Frassi, 2004 |
Italy Not specified |
Pregnancies in women suffering from connective tissue diseases (CTD). | Pregnancies in women treated with hydroxychloroquine (HCQ). |
unexposed, sick
Pregnancies in women not exposed to hydroxychloroquine (HCQ). |
76 / 80 | |
| Gernaat (Controls unexposed, disease free), 2022 |
Sweden 2006 - 2016 |
All singleton pregnancies among women who had a delivery registered during the study period. | Pregnant women with Systemic Lupus Erythematosus (SLE) which received at least 1 Hydroxychloroquine (HCQ) dispensation during 6 months before or any time during pregnancy. |
unexposed, disease free
Pregnant women randomly sampled from the general population without Systemic Lupus Erythematosus (SLE). |
287 / 4644 | |
| Gernaat (Controls unexposed, sick), 2022 |
Sweden 2006 - 2016 |
All singleton pregnancies among women who had a delivery registered during the study period. | Pregnant women with Systemic Lupus Erythematosus (SLE) which received at least 1 Hydroxychloroquine (HCQ) dispensation during 6 months before or any time during pregnancy. |
unexposed, sick
Pregnant women with Systemic Lupus Erythematosus (SLE) which not received any Hydroxychloroquine (HCQ) dispensation before or during pregnancy. |
287 / 408 | |
| Haase, 2020 |
Germany Not specified. |
Live births from singleton pregnancies in women with Systemic Lupus Erythematosus (SLE) from an outpatient pregnancy clinic. | Pregnancies in women with Systemic Lupus Erythematosus (SLE) under hydroxychloroquine (HCQ) treatment from 1st trimester. |
unexposed, sick
Pregnancies of women with Systemic Lupus Erythematosus (SLE) without hydroxychloroquine (HCQ) therapy. |
77 / 107 | Overlapping: results for preeclampsia not reported here because specifically studied in an other study using the same dataset (Haase 2020b) and giving more details. |
| Haase, 2021 |
Germany 1995 - 2019 |
Pregnancies in women with Systemic Lupus Erythematosus (SLE) from an outpatient pregnancy clinic. | Pregnancies in women with Systemic Lupus Erythematosus (SLE) under hydroxychloroquine (HCQ) treatment from 1st trimester. |
unexposed, sick
Pregnancies of women with Systemic Lupus Erythematosus (SLE) without hydroxychloroquine (HCQ) therapy. |
82 / 108 | Number of exposures to hydroxychloroquine (HCQ) = sum of HCQ only and Low dose Aspirin (LDA). |
| Howren, 2020 |
Canada 2002 - 2012 |
All births (livebirths and stillbirths) from women with Rheumatic diseases (RD), including rheumatoid arthritis (RA), systemic autoimmune rheumatic diseases (SARDs), and other RD including ankylosing spondylititis (AS), psoriatic arthritis (PsA), and juvenile idiopathic arthritis (JIA). | Pregnancies in women with Rheumatic diseases (RD) with at least one prescription of hydroxychloroquine filled during the critical windows of interest (90 days post conception for malformations and from conception to delivery for small-for-gestational-age). |
unexposed, sick
Pregnancies in women with Rheumatic diseases (RD) without filled prescriptions for conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs; e.g. hydroxychloroquine, methotrexate) during aforementioned perinatal windows of interest. |
114 / 6064 | Systemic auto-immune rheumatic diseases (SARDs), and other RD including ankylosing spondylititis (AS), psoriatic arthritis (PsA), and juvenile idiopathic arthritis (JIA) |
| Huybrechts (Controls unexposed, NOS), 2021 |
USA 2000 - 2015 |
All live-born infants linked to completed pregnancies in women 12 to 55 years (continuously insured from 3 months before the start of pregnancy to 1 month after delivery). | Pregnant women that filled a prescription for Hydroxychloroquine during the first trimester of pregnancy (defined as the date of the last menstrual period to day 90 of pregnancy). |
unexposed (general population or NOS)
Pregnant women without a prescription for Hydroxychloroquine for 3 months before the start of pregnancy to the end of the first trimester of pregnancy |
2045 / 3198589 | Estimates were consistent between the 2 cohorts, therefore pooled estimations were reported. The risk of malformations among the HCQ- exposed women was the same regardless of whether women had concomitant exposure to steroids. |
| Huybrechts (Controls unexposed, sick), 2021 |
USA 2000 - 2015 |
All live-born infants linked to completed pregnancies in women 12 to 55 years (continuously insured from 3 months before the start of pregnancy to 1 month after delivery). | Pregnant women that filled a prescription for Hydroxychloroquine during the first trimester of pregnancy (defined as the date of the last menstrual period to day 90 of pregnancy). |
unexposed, sick
Pregnant women with a recorded diagnosis of autoimmune rheumatic disorders without a prescription for Hydroxychloroquine for 3 months before the start of pregnancy to the end of the first trimester of pregnancy |
2045 / 21679 | Estimates were consistent between the 2 cohorts, therefore pooled estimations were reported. The risk of malformations among the HCQ- exposed women was the same regardless of whether women had concomitant exposure to steroids. |
| Kroese, 2017 |
Netherlands 2000 - 2015 |
All pregnancies in women with systemic lupus erythematosus (SLE) seen at the University Medical Center (UMC) Utrecht. | Pregnancies in women with systemic lupus erythematosus (SLE) that used hydroxychloroquine (HCQ). |
unexposed, sick
Pregnancies in women with systemic lupus erythematosus (SLE) that not used hydroxychloroquine (HCQ). |
30 / 80 | Terminated pregnancies due to social reasons were not included in this study. The dose of hydroxychloroquine used in the pregnancies was 200 mg/day (16 pregnancies) or 400 mg/day (14 pregnancies). |
| Langen, 2014 |
USA 2001 - 2009 |
All pregnancies complicated by Rheumatoid arthritis (RA) delivered at the institution. | Women with Rheumatoid arthritis (RA) and hydroxychloroquine near the time of conception. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Women with Rheumatoid arthritis (RA) and prednisone only near the time of conception. (This is a subgroup of exposure among the whole exposed group considered in the study). |
13 / 15 | HCQ was discontinued in 7/13 pregnancies upon discovery of pregnancy (but long half life). |
| Leroux, 2015 |
France 2001 - 2011 |
Pregnant women with Systemic lupus erythematosus (SLE) who delivered after 22 weeks at Bordeaux University Hospital (France). | Pregnant patients with Systemic lupus erythematosus (SLE) who received Hydroxychloroquine (HCQ) throughout the pregnancy. |
unexposed, sick
Pregnant patients with Systemic lupus erythematosus (SLE) that did not take Hydroxychloroquine (HCQ) neither in the six months prior nor during pregnancy. |
41 / 77 | HCQ was administered at a single dose of 400mg/day for all of the patients. No significant difference was found between the two groups for other drugs given during pregnancy (prednisone, LMWH, azathiprine, low dose acetylsalicylic acid). |
| Levy, 2001 |
Brazil Not specified |
Pregnant patients diagnosed with systemic lupus erythematosus (SLE) or biopsy-proven discoid lupus erythematosus (DLE) for more than 1 year. | Pregnant patients with Lupus erythematosus (systemic or discoid) that received hydroxychloroquine beginning between 8 and 18 weeks of pregnancy (average of 11 weeks for both groups). |
unexposed, sick
Pregnant patients with Lupus erythematosus (systemic or discoid) that received placebo beginning between 8 and 18 weeks of pregnancy (average of 11 weeks for both groups). |
10 / 10 | Delivery age and Apgar scores were higher in the HCQ group (not stat signif). All the children achieved percentiles > 50 for height and weight and achieved satisfactory cognitive development and were able to perform activities expected for their ages. |
| Liu, 2021 |
China 2004 - 2019 |
Pregnant women with Systemic lupus erythematosus (SLE) who had their delivery records at Peking University First Hospital in Beijing, China. | Pregnancies with Systemic lupus erythematosus (SLE) that received Hydroxychloroquine throughout the pregnancy or immediately after the diagnosis of SLE during pregnancy. |
unexposed, sick
Pregnant women with Systemic lupus erythematosus (SLE) that did not take HCQ 3 months before implantation or during pregnancy. |
53 / 66 | |
| Louthrenoo, 2021 |
Thailand 1993 - 2017 |
Pregnant systemic lupus erythematosus (SLE) patients | Pregnancies in lupus erythematosus (SLE) patients that used Hydroxychloroquine during pregnancy. |
unexposed, sick
Pregnancies in systemic lupus erythematosus (SLE) patients that not used Hydroxychloroquine during pregnancy. |
43 / 47 | Nb of exposures and non exposures extracted from Table 4. |
| Mollerach, 2019 |
Argentina 2000 - 2014 |
All pregnant women with anti-Ro/La-positive antibodies in the laboratory registries. (This is a subgroup of population among the whole population considered in the study) | Pregnancy in women with anti-Ro/La-positive antibodies treated with hydroxychloroquine (200– 400 mg/day) during all their pregnancy. |
unexposed, sick
Pregnancy in women with anti-Ro/La-positive antibodies without hydroxychloroquine during pregnancy. |
14 / 48 | From the group of mothers who consumed hydroxychloroquine during all their pregnancy, nine consumed 400 mg/day of hydroxychloroquine whereas five consumed 200 mg/day. |
| Moroni, 2016 |
Italy 2006 - 2013 |
Pregnant patients with lupus nephritis with a counselling visit within 3 months before the beginning of pregnancy. | Outcomes of women with lupus nephritis treated with hydroxychloroquine at conception. |
unexposed, sick
Outcomes of women with lupus nephritis not treated with hydroxychloroquine at conception. |
37 / 31 | |
| Poh, 2020 |
Singapore 2000 - 2016 |
Pregnant patients with systemic lupus erythematosus (SLE) who were followed up in Singapore General Hospital, | Use of Hydroxychloroquine during pregnancy in systemic lupus erythematosus (SLE) patients. |
unexposed, sick
No use of Hydroxychloroquine during pregnancy in systemic lupus erythematosus (SLE) patients. |
40 / 63 | OR not reported because aberrant value ((OR 0, CI 0–0.054)) and raw data not available to calculate OR. |
| Reynolds, 2022 |
United Kingdom 2007 - 2011 |
Women who had >=4 criteria for systemic lupus erythematosus (SLE) prior to pregnancy and who regularly attended a rheumatology outpatient department. | Pregnancies with Hydroxychloroquine exposure during pregnancy (continued throughout pregnancy and breastfeeding in almost all cases). |
unexposed, sick
Pregnancies without Hydroxychloroquine exposure during pregnancy. |
149 / 135 | Only live-born children were included. As HCQ or AZA were continued throughout pregnancy and breastfeeding in almost all cases, exposure was combined into a single variable for each drug. |
| Seo, 2019 |
Republic of Korea 1995 - 2018 |
Women with Systemic lupus erythematosus (SLE) who were managed at the rheumatology center in the author's institution, a tertiary care university hospital and referral center. | Pregnancies in Systemic lupus erythematosus (SLE) patients exposed to Hydroxychloroquine (HCQ) throughout the index pregnancy. |
unexposed, sick
Pregnancies in Systemic lupus erythematosus (SLE) patients not exposed to Hydroxychloroquine (HCQ) within three months before pregnancy or during pregnancy. |
80 / 71 | |
| Tang, 2022 |
China 2003 - 2021 |
Patients with biopsy-proven IgA nephropathy and singleton gestation who were aged 18 to 40 years with completed pregnancies resulting in live-born infants. | Patients with biopsy-proven IgA nephropathy and prescription of Hydroxychloroquine at any time during pregnancy. |
unexposed, sick
Patients with biopsy-proven IgA nephropathy, without prescription of Hydroxychloroquine at any time during pregnancy. |
25 / 63 | All patients enrolled in this study discontinued renin–angiotensin–aldosterone system inhibitors therapy when pregnancy was planned or detected. |
| Tincani, 2005 |
Italy Not specified |
Pregnancies in women suffering from connective tissue diseases (CTD). | Pregnancies in women suffering from connective tissue diseases (CTD), treated with hydroxychloroquine (HCQ). |
unexposed, sick
Pregnancies in women suffering from connective tissue diseases (CTD), not exposed to hydroxychloroquine (HCQ). |
76 / 80 | Review provided data published in scientific literature, including a study previously published by authors (Frassi 2004), with 3 additional outcomes: preterm, spontaneous abortions and stillbirths that were reported here; with protocol of Frassi 2004. |
| Viktil (Controls exposed to other treatments), 2012 |
Norway 2004 - 2007 |
Singleton pregnancies in women receiving at least 1 prescription during the study period. | Women with dispensation of Hydroxychloroquine from 3 months prior to pregnancy to delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Women with dispensation of other anti-rheumatic drugs (Prednisolone, NSAIDs, Sulfasalazine, Hydroxychloroquine, Etanercept, Adalimumab, Methotrexate, Leflunomid, or Anakinra) from 3 months prior to pregnancy to delivery. |
58 / 1360 | Analysis performed on anti-rheumatic drugs as a whole, no individual analyse for each substance. Raw data (number of exposed pregnancies and malformations) were available in the text and were used for this meta-analysis. |
| Viktil (Controls unexposed, NOS), 2012 |
Norway 2004 - 2007 |
Singleton pregnancies in women receiving at least 1 prescription during the study period. | Women with dispensation of Hydroxychloroquine from 3 months prior to pregnancy to delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Singleton pregnancies whose mothers did not received an anti-rheumatic drugs in the period 3 months prior to conception until labour. |
58 / 154976 | Analysis performed on anti-rheumatic drugs as a whole, no individual analyse for each substance. Raw data (number of exposed pregnancies and malformations) were available in the text and were used for this meta-analysis. |
| Vroom (controls exposed to sulfasalazine), 2009 |
United Kingdom 1992 - 2006 |
All women who were permanently registered (in GPRD) with their practice and aged 11-49 at the pregnancy end-date. | Women that was prescribed hydroxychloroquine at any time between 3 months before and 3 months after pregnancy (then analyzes performed according to trimester of pregnancy). (This is a subgroup of exposure among the whole exposed group considered in the study) |
exposed to other treatment, sick
Women that was prescribed sulfasalazine. |
-9 / -9 | |
| Vroom (controls unexposed, disease free), 2009 |
United Kingdom 1992 - 2006 |
All women who were permanently registered (in GPRD) with their practice and aged 11-49 at the pregnancy end-date. | Women that was prescribed hydroxychloroquine at any time between 3 months before and 3 months after pregnancy (then analyzes performed according to trimester of pregnancy). (This is a subgroup of exposure among the whole exposed group considered in the study) |
unexposed, disease free
The general population not prescribed Disease Modifying Antirheumatic Drugs in pregnancy (DMARDs) during pregnancy |
-9 / 583447 |
| Study | Country Study period |
Case | Control | Sample size | Rmk |
|---|---|---|---|---|---|
| Andreoli, 2022 |
Italy Not specified. |
Children with neurodevelopmental disorders (learning disabilities, attention deficiency and hyperactivity disorder, autism spectrum disorder). | Children without neurodevelopmental disorders (learning disabilities, attention deficiency and hyperactivity disorder, autism spectrum disorder). | 11 / 288 | No overlapping with Lazzaroni 2020, not the same disease ('This paper focuses on the follow-up of children born to patients with RD, as the other themes have already been the subject of a previous paper'). |
| Bérard, 2021 |
Canada 1998 - 2015 |
Pregnancies resulted in a premature delivery, or a low birth weight, or a small for gestational age, or a major congenital malformation. | Pregnancies not resulted in the studied outcome (premature delivery, or a low birth weight, or a small for gestational age, or a major congenital malformation). | 23991 / 207084 | Within the study population: 15,032 pregnancies resulted in a premature delivery; 11,606 low birthweight; 22,280 small for gestational age newborns and 23,991 major malformations. |
| Braga, 2021 |
Portugal 1993 - 2019 |
Pregnancy with Adverse pregnancy outcome (APO) defined as the occurrence of miscarriage, stillbirth, fetal growth restriction, preterm, or the development of hypertensive disorders of pregnancy | Normal pregnancy (i.e, without Adverse pregnancy outcome (APO)). | 89 / 126 | |
| He, 2022 |
Japan 2013 - 2020 |
Pregnancies with adverse pregnancy outcomes. | Pregnancies without adverse pregnancy outcomes. | 68 / 42 | |
| Howley - BDS study, 2021 |
USA 1976 - 2015 |
Infants with any major birth defect. | Liveborn infants without birth defects identified from study hospitals and birth certificates in the same catchment areas as case participants. | 29838 / 12868 | Reported indications included systemic lupus erythematosus (n = 19), rheumatoid arthritis (n = 11), psoriatic arthritis (n = 1), other rheumatic diseases (...), connective tissue disorder (n = 1), fibromyalgia (n = 1), and unknown indication (n = 4). |
| Howley - NBDPS study, 2021 |
USA 1997 - 2011 |
Pregnancies affected by one or more of 30 categories of major structural birth defects, excluding those attributed to a known chromosomal or single-gene abnormality. | Live births without major birth defects randomly selected from hospital records or birth certificates in the same time period and geographic area as the cases. | 31468 / 11614 | Reported indications included systemic lupus erythematosus (n = 19), rheumatoid arthritis (n = 11), psoriatic arthritis (n = 1), other rheumatic diseases (...), connective tissue disorder (n = 1), fibromyalgia (n = 1), and unknown indication (n = 4). |
| Kiatkongchuchai, 2020 |
Thailand 2012 - 2018 |
Systemic Lupus Erythematosus (SLE) pregnant patients with preeclampsia. | Systemic Lupus Erythematosus (SLE) pregnant patients without preeclampsia | -9 / -9 | Raw data not provided (Abstract). |
| Placais, 2019 |
France 2011 - 2015 |
Patients consulting for obstetrical morbidity (early recurrent miscarriage, intrauterine death; intra-uterine growth restriction; preeclampsia, eclampsia prematurity). | Patients without fetal loss/obstetrical complication. | 83 / 16 | |
| Zhang, 2022 |
China 2014 - 2020 |
59 / 64 | Hydroxychloroquine was prescribed to patients with a dose of 100 to 400 mg daily. |
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