{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T23:15:06Z","timestamp":1782774906308,"version":"3.54.5"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2023,6,21]],"date-time":"2023-06-21T00:00:00Z","timestamp":1687305600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,3,28]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>The objective of the study was to compare the efficacy of intravenous immunoglobulin (IVIG) therapy for obstetric antiphospholipid syndrome (APS) refractory to conventional treatment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a single-arm, open-label multicentre clinical intervention trial. The enrolled criteria were patients with refractory APS who had a history of still or premature birth before 30\u2009weeks of gestational age, even though they had been treated with conventional treatment, i.e.\u00a0heparin and low-dose aspirin. After confirming the foetal heartbeats, a single course of IVIG (0.4\u2009g\/kg body weight daily for 5\u2009days) was added to conventional treatment. The primary outcome was a live birth ratio of &amp;gt;30\u2009weeks of gestational period, and the secondary outcome included improving pregnancy outcomes compared to previous pregnancy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Twenty-five per cent of patients (2 of 8 cases) achieved a live birth after the 30th week of pregnancy by IVIG-only add-on treatment, which is the same prevalence as the historical control. However, by adding other second-line therapy to IVIG and conventional treatment, further three patients (37.5%) achieved improvements in pregnancy outcome compared to previous treatments. In total, five patients (62.5%) were able to achieve preferable pregnancy outcomes through combination treatment including IVIG.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This clinical trial could not demonstrate the efficacy of IVIG-only add-on therapy at improving the pregnancy outcomes of patients with obstetric APS refractory to conventional treatment. However, the combination of IVIG with rituximab or statins adding to conventional treatment improved pregnancy outcomes and resulted in more live births. Further studies are needed to investigate the efficacy of multi-targeted therapy to treat obstetric refractory APS.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/mr\/road062","type":"journal-article","created":{"date-parts":[[2023,6,21]],"date-time":"2023-06-21T07:51:49Z","timestamp":1687333909000},"page":"515-522","source":"Crossref","is-referenced-by-count":10,"title":["Intravenous immunoglobulin treatment for obstetric antiphospholipid syndrome refractory to conventional therapy: A single-arm, open-labelled multicentre clinical trial"],"prefix":"10.1093","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3411-5896","authenticated-orcid":false,"given":"Kayoko","family":"Kaneko","sequence":"first","affiliation":[{"name":"Division of Maternal Medicine, Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seiji","family":"Tsutsumi","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Yamagata University Hospital , Yamagata, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Fujita","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Osaka Medical and Pharmaceutical University , Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mayumi","family":"Sugiura-Ogasawara","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Nagoya City University, Graduate School of Medical Science , Nagoya, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuaki","family":"Mitsuda","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Osaka Women\u2019s and Children\u2019s Hospital , Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiichi","family":"Matsubara","sequence":"additional","affiliation":[{"name":"Department of Regional Pediatrics and Perinatology, Ehime University Graduate School of Medicine , Ehime, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuya","family":"Atsumi","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University , Sapporo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eisuke","family":"Inoue","sequence":"additional","affiliation":[{"name":"Showa University Research Administration Center, Showa University , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuya","family":"Takimoto","sequence":"additional","affiliation":[{"name":"Children\u2019s Cancer Center, National Center for Child Health and Development , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsuko","family":"Murashima","sequence":"additional","affiliation":[{"name":"Division of Maternal Medicine, Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,6,21]]},"reference":[{"key":"2024061307164320500_R1","doi-asserted-by":"crossref","first-page":"295","DOI":"10.1111\/j.1538-7836.2006.01753.x","article-title":"International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS)","volume":"4","author":"Miyakis","year":"2006","journal-title":"J Thromb Haemost"},{"key":"2024061307164320500_R2","first-page":"135","article-title":"Recurrent pregnancy loss with antiphospholipid antibody: a systematic review of therapeutic 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