{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T10:26:23Z","timestamp":1771064783864,"version":"3.50.1"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2021,3,12]],"date-time":"2021-03-12T00:00:00Z","timestamp":1615507200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,3,12]],"date-time":"2021-03-12T00:00:00Z","timestamp":1615507200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Novo Nordisk Health Care AG"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pituitary"],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>Data on the safety of growth hormone (GH) replacement therapy during pregnancy are limited. We report a combined analysis of data from pregnant women treated with GH while enrolled in two non-interventional, multicenter studies: NordiNet\u00ae International Outcome Study (IOS) and the American Norditropin\u00ae Studies: Web-Enabled Research (ANSWER) Program.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Pregnancy data were pooled from NordiNet\u00ae\u00a0IOS and the ANSWER Program. Data were collected during routine clinic visits by participating physicians using a web-based system. Patients exposed to GH replacement therapy during pregnancy were included in the analysis.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The study population included 40 female patients with typical causes of adult GH deficiency (GHD). Overall, there were 54 pregnancies. Of these, 47 were exposed to GH between conception and delivery. In 48.9% of pregnancies exposed to GH, the dose was\u2009&gt;\u20090.6\u00a0mg\/day. GH was continued past conception and then stopped during the first, second, and third trimester, in 27.7%, 17.0%, and 2.1% of pregnancies, respectively. In 29.8%, GH was continued throughout pregnancy, with an unchanged dose in most cases. Of the 47 GH-exposed pregnancies, 37 (78.7%) progressed to normal delivery. There were three adverse events reported in two pregnancies.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>These real-world data suggest that there were no new safety signals related to GH exposure in women with GHD during pregnancy. These results are consistent with findings from previous studies reporting data in pregnancies exposed to GH at conception or throughout pregnancy. This observational study in additional pregnancies provides further evidence that GH exposure does not adversely affect pregnancy outcome.<\/jats:p>\n                <jats:p><jats:bold>Clinical trial registration:<\/jats:bold> ClinicalTrials.gov NCT00960128 (date of registration: August 13, 2009) and NCT01009905 (date of registration: November 5, 2009).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s11102-021-01138-3","type":"journal-article","created":{"date-parts":[[2021,3,12]],"date-time":"2021-03-12T04:35:53Z","timestamp":1615523753000},"page":"611-621","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Pregnancy outcomes in women receiving growth hormone replacement therapy enrolled in the NordiNet\u00ae International Outcome Study (IOS) and the American Norditropin\u00ae Studies: Web-Enabled Research (ANSWER) Program"],"prefix":"10.1007","volume":"24","clinical-trial-number":[{"clinical-trial-number":"nct00960128","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01009905","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4359-4622","authenticated-orcid":false,"given":"Beverly M. 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CH was a NordiNet\u00ae\u00a0IOS investigator and has received lecture fees from Novo\u00a0Nordisk, Pfizer and Sandoz, and is a member of the global steering committee for the PATRO study (Sandoz) and has consulted for Novo\u00a0Nordisk and Ascendis. PC has received honoraria for participation in advisory boards for Shire, Pfizer, and Novo Nordisk. MBG reports research support from Camurus, Chiasma, Corcept, Crinetics, Ipsen, Novartis, Novo\u00a0Nordisk, Opko, Pfizer, Strongbridge, and Teva; and has been a scientific consultant to Chiasma, Ipsen, and Novo\u00a0Nordisk. ACB, and NN are employees of Novo Nordisk. NK is an employee of Novo\u00a0Nordisk and has stocks in Novo Nordisk and Pfizer. MMW has received honoraria for participation in advisory boards and as a speaker from Novartis, Ipsen and Novo\u00a0Nordisk, and research grants from Ipsen and Novartis.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Both studies were conducted with approval from relevant ethics committees, written consent from patients, and pseudonymization of all data in accordance with the Declaration of Helsinki, Guideline for Good Pharmacoepidemiology Practices, and regulatory requirements.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Written consent was obtained from patients for the two original studies.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"These data were previously presented in poster form at the virtual 22nd European Congress of Endocrinology (eECE), 5\u20139 September, 2020.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Prior publication"}}]}}