| id | Study | Lib. in paper | Exposition period | Study type |
Control type |
Tags | OR 95%CI | x1/n1 x0/n0 | no cases | no exposed | ROB | Ref. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| S18158 R76356 |
Chan (Controls exposed to TCA), 2024 | Cardiac malformations | 1st trimester | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No Monotherapy: SSRI only |
0.73 [0.35;1.50] C excluded (control group) |
24/956 11/322 | 35 | 956 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S18138 R76242 |
Chan (Controls unexposed, general pop), 2024 | Cardiac malformations | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) excluded | Adjustment: Yes Monotherapy: SSRI only |
1.19 [0.68;2.11] excluded (control group) |
24/956 8,107/462,377 | 8,131 | 956 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S18139 R76248 |
Chan (Controls unexposed, sick), 2024 | Cardiac malformations | 1st trimester | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes Monotherapy: SSRI only Unexposed sick: old history of illness/treatment (> 12 months before pregnancy) or not specified | 1.10 [0.55;2.22] | 16/714 95/4,413 | 111 | 714 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S12482 R47059 |
Benevent, 2023 | Circulatory system anomaly | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No Monotherapy: SSRI only | 0.68 [0.28;1.65] C | 5/1,653 649/146,855 | 654 | 1,653 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S16846 R70635 |
Kawai, 2023 | Congenital Heart Defects | early pregnancy | nested case control | unexposed (general population or NOS) | Adjustment: No Monotherapy: no or not specified | 1.39 [0.44;4.35] | 3/158 1,261/91,506 | 1,264 | 158 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S13112 R49966 |
Marks - Sertraline (Controls exposed to Bupropion), 2021 | Cardiac Malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | exposed to other treatment, sick | Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) |
1.22 [0.66;2.23] C excluded (exposition period) |
64/1,653 13/406 | 77 | 1,653 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S7467 R22080 |
Anderson, 2020 | Any heart defect | 1st trimester | case control | unexposed (general population or NOS) | Adjustment: Yes Monotherapy: SSRI only | 1.33 [1.15;1.54] | -/- 0/- | - | - |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6704 R18917 |
Bérard - Non Sertraline SSRI, 2015 | Cardiac malformations | 1st trimester | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes Monotherapy: SSRI only Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) | 1.10 [0.82;1.48] | 51/1,963 344/14,868 | 395 | 1,963 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S516 R15349 |
Furu (Controls unexposed, NOS), 2015 | Any cardiac defects | 1st trimester | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes Monotherapy: SSRI only | 1.15 [1.05;1.26] | 564/36,772 26,745/2,266,875 | 27,309 | 36,772 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6691 R18754 |
Furu (Controls unexposed, sibling), 2015 | Any cardiac defects | 1st trimester | population based cohort retrospective | sibling excluded | Adjustment: Yes Monotherapy: SSRI only |
0.92 [0.72;1.17] excluded (control group) |
-/422 -/569 | - | 422 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S7348 R21403 |
Wemakor, 2015 | Congenital heart defects | 1st trimester | case control | unexposed (general population or NOS) | Adjustment: Yes Monotherapy: SSRI only | 1.41 [1.07;1.86] | 108/207 12,768/29,752 | 12,876 | 207 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S5881 R14669 |
Ban (Controls exposed to TCA), 2014 | Heart congenital malformations | 1st trimester | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No Monotherapy: SSRI only |
1.08 [0.65;1.77] C excluded (control group) |
68/7,683 20/2,428 | 88 | 7,683 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S517 R14647 |
Ban (Controls unexposed, disease free), 2014 | Heart congenital malformations | 1st trimester | retrospective cohort (claims database) | unexposed, disease free excluded | Adjustment: Yes Monotherapy: SSRI only |
1.14 [0.89;1.45] excluded (control group) |
68/7,683 2,444/325,294 | 2,512 | 7,683 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6700 R18874 |
Ban (Controls unexposed, sick), 2014 | Heart congenital malformations | 1st trimester | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes Monotherapy: SSRI only Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) | 1.04 [0.76;1.41] | 68/7,683 112/13,432 | 180 | 7,683 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S494 R342 |
Huybrechts (Controls unexposed, NOS), 2014 | Any cardiac malformations | 1st trimester | cohort | unexposed (general population or NOS) excluded | Adjustment: No Monotherapy: no or not specified |
1.25 [1.13;1.38] excluded (control group) |
416/46,144 6,403/885,115 | 6,819 | 46,144 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6097 R15882 |
Huybrechts (Controls unexposed, sick), 2014 | Any cardiac malformations | 1st trimester | cohort | unexposed, sick | Adjustment: Yes Monotherapy: no or not specified Unexposed sick: old history of illness/treatment (> 12 months before pregnancy) or not specified | 1.08 [0.94;1.23] | 341/36,783 1,497/180,564 | 1,838 | 36,783 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S5386 R15148 |
Margulis, 2013 | Cardiac malformations (first year of life) | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No Matched Monotherapy: SSRI only | 1.00 [0.50;2.00] | 16/3,046 48/8,991 | 64 | 3,046 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S496 R61459 |
Nordeng (Controls unexposed, NOS), 2012 | Cardiovascular malformations | 1st trimester | cohort | unexposed (general population or NOS) excluded | Adjustment: Yes Monotherapy: no or not specified Partial overlapping |
1.51 [0.67;3.43] excluded (control group) |
6/462 541/61,648 | 547 | 462 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S7830 R61473 |
Nordeng (Controls unexposed, sick), 2012 | Cardiovascular malformations | 1st trimester | cohort | unexposed, sick | Adjustment: No Monotherapy: no or not specified Partial overlapping Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) | 1.96 [0.65;5.85] C | 6/462 7/1,048 | 13 | 462 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S493 R15238 |
Colvin, 2011 | Cardiovascular defects | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No Monotherapy: no or not specified | 1.60 [1.10;2.31] | 30/2,701 661/94,561 | 691 | 2,701 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6999 R76905 |
Reis (Controls exposed to TCA), 2010 | Any cardiovascular defect | early pregnancy | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No Monotherapy: SSRI only |
0.59 [0.39;0.89] C excluded (control group) |
109/10,170 30/1,662 | 139 | 10,170 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S5410 R76900 |
Reis (Controls unexposed, NOS), 2010 | Any cardiovascular defect | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes Monotherapy: SSRI only | 0.99 [0.82;1.20] | 109/10,170 -/1,062,190 | - | 10,170 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S499 R369 |
Merlob, 2009 | Nonsyndromic congenital heart malformations | 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No Monotherapy: no or not specified | 2.17 [1.07;4.39] | 8/235 1,083/67,636 | 1,091 | 235 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S5958 R15307 |
Diav-Citrin - Fluoxetine or Paroxetine, 2008 | Major cardiovascular anomalies | 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: Yes Monotherapy: no or not specified | 2.66 [0.80;8.90] | 7/348 8/1,359 | 15 | 348 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S504 R352 |
Einarson - Paroxetine, 2008 | Cardiovascular defects | 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No Monotherapy: no or not specified | 1.10 [0.36;2.78] | 9/1,174 -/- | - | 1,174 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S7288 R21079 |
Maschi - Paroxetine, 2008 | Cardiac malformations | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed (general population or NOS) | Adjustment: No Matched Monotherapy: no or not specified |
18.45 [0.74;458.58] C excluded (exposition period) |
1/58 0/348 | 1 | 58 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S520 R17637 |
Oberlander a, 2008 | Cardiovascular congenital defects | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No Monotherapy: SSRI only | 1.36 [0.84;2.21] C | 17/2,625 512/107,320 | 529 | 2,625 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S5394 R41660 |
Davis, 2007 | Congenital heart defects | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No Monotherapy: no or not specified | 0.88 [0.54;1.43] C | 17/805 1,171/49,031 | 1,188 | 805 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S5424 R16095 |
Louik, 2007 | Any cardiac defect | 1st trimester | case control | unexposed (general population or NOS) | Adjustment: Yes Monotherapy: no or not specified | 1.20 [0.90;1.60] | 100/260 3,624/9,324 | 3,724 | 260 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S507 R16623 |
Vial - Paroxetine, 2006 | Major cardiac defects | 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No Matched Monotherapy: no or not specified | 1.18 [0.24;5.87] C | 3/535 3/631 | 6 | 535 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6994 R19836 |
Simon (Controls exposed to TCA), 2002 | Cardiac malformations | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No Monotherapy: SSRI only |
4.60 [0.51;41.50] C excluded (control group) |
4/185 1/209 | 5 | 185 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S492 R17424 |
Simon (Controls unexposed, NOS), 2002 | Cardiac malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No Matched Monotherapy: SSRI only |
9.20 [0.49;172.11] C excluded (exposition period) |
4/185 0/185 | 4 | 185 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S513 R49343 |
Kulin, 1998 | Cardiac malformations (among neonates) | 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No Monotherapy: no or not specified | 0.53 [0.10;2.90] C | 2/222 4/235 | 6 | 222 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 21 studies | 1.17 [1.09;1.25] | 51,954 | 108,516 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1: Controls unexposed, sick; 2: Controls unexposed, NOS; 3: Controls unexposed, sick; 4: Controls unexposed, sick; 5: Controls unexposed, sick; 6: Controls unexposed, NOS;
Asymetry test p-value = 0.5581 (by Egger's regression)
slope=0.1316 (0.0456); intercept=0.2093 (0.3510); t=0.5961; p=0.5581
excluded 6994, 6999, 496, 5881, 517, 494, 6691, 18158, 18138