{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T17:45:18Z","timestamp":1760204718983},"reference-count":21,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,2,2]],"date-time":"2015-02-02T00:00:00Z","timestamp":1422835200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"German Federal Institute for Drugs and Medical Devices"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2015,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>The results of observational cohort studies on drug effects on pregnancy outcome may depend among others on suitable comparison cohorts. The aim of this investigation was to compare two distinct definitions of maternal exposure status for comparison cohorts.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed an observational cohort study of prospectively ascertained pregnant women who spontaneously contacted the Teratology Information Service (TIS) Berlin for drug risk consultation. The only exclusion criteria were exposures to established teratogens and\/or fetotoxicants. Pregnancy outcomes of 3250 women with this \u201caverage drug exposure\u201d were compared with 546 non\u2010exposed or insignificantly exposed pregnancies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Neither the rate of major birth defects (3.0%; aOR 1.62; 95% CI 0.8\u20133.3) nor the risk of spontaneous abortion (16.0%; aHR 1.20; 95% CI 0.8\u20131.7) was significantly increased after average drug exposure, whereas the rate of electively terminated pregnancies was higher (11.1%; aHR 2.05; 95% CI 1.2\u20133.4). There were no differences in the risk of preterm birth (9.9%; aOR 1.38; 95% CI 0.9\u20132.0) and infants' birth weight (<jats:italic>p<\/jats:italic>\u2009=\u20090.60).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study does not provide evidence for an increased risk of adverse pregnancy outcome after average drug exposure during pregnancy. Therefore, comparison cohorts with average drug exposure are appropriate for studies on potential teratogens or fetotoxicants based on observational data collected by TIS. Copyright \u00a9 2015 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3744","type":"journal-article","created":{"date-parts":[[2015,2,2]],"date-time":"2015-02-02T20:29:39Z","timestamp":1422908979000},"page":"353-360","source":"Crossref","is-referenced-by-count":15,"title":["Does the average drug exposure in pregnant women affect pregnancy outcome? A comparison of two approaches to estimate the baseline risks of adverse pregnancy outcome"],"prefix":"10.1002","volume":"24","author":[{"given":"Evelin","family":"Wacker","sequence":"first","affiliation":[{"name":"Pharmakovigilanz\u2010 und Beratungszentrum f\u00fcr Embryonaltoxikologie (Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy) Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Navarro","sequence":"additional","affiliation":[{"name":"Berlin School of Public Health Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reinhard","family":"Meister","sequence":"additional","affiliation":[{"name":"Department of Mathematics Beuth Hochschule f\u00fcr Technik Berlin (University of Applied Sciences)  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie","family":"Padberg","sequence":"additional","affiliation":[{"name":"Pharmakovigilanz\u2010 und Beratungszentrum f\u00fcr Embryonaltoxikologie (Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy) Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corinna","family":"Weber\u2010Schoendorfer","sequence":"additional","affiliation":[{"name":"Pharmakovigilanz\u2010 und Beratungszentrum f\u00fcr Embryonaltoxikologie (Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy) Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christof","family":"Schaefer","sequence":"additional","affiliation":[{"name":"Pharmakovigilanz\u2010 und Beratungszentrum f\u00fcr Embryonaltoxikologie (Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy) Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,2,2]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2013-004365"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajmg.c.30303"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1741-4520.2010.00308.x"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.330.7496.895"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2012.04.081"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/ket390"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2012.05.001"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011429566"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61602-X"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2008.05.064"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02413-14"},{"key":"e_1_2_9_13_1","unstructured":"EUROCATGuide 1.3 and reference documents\u2014instructions for the registration and surveillance of congenital anomalies. 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