{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T04:25:47Z","timestamp":1771475147431,"version":"3.50.1"},"reference-count":27,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2017,7,11]],"date-time":"2017-07-11T00:00:00Z","timestamp":1499731200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2017,10]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>The aims of the present study were to investigate the maternal, fetal and neonatal safety and tolerability, pharmacodynamics and pharmacokinetics of intravenous (IV) retosiban in pregnant women with spontaneous preterm labour (PTL) between 34<jats:sup>0\/7<\/jats:sup> and 35<jats:sup>6\/7<\/jats:sup>\u00a0weeks' gestation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In parts A and B of a three\u2010part, double\u2010blind, placebo\u2010controlled, multicentre study, women were randomized 3:1 (Part A) or 2:1 (Part B) to either 12\u2010h IV retosiban followed by a single dose of oral placebo (R\u2010P) or 12\u2010h IV placebo followed by single\u2010dose oral retosiban (P\u2010R).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 29 women were randomized; 20 to R\u2010P and nine to P\u2010R. An integrated analysis found that adverse events were infrequent in mothers\/newborns and consistent with events expected in the population under study or associated with confounding factors. Retosiban was rapidly absorbed after oral administration, with an observed half\u2010life of 1.45\u00a0h. Efficacy analyses included 19 women. While not statistically significant, those receiving R\u2010P more frequently achieved uterine quiescence in 6\u00a0h (R\u2010P, 63%; 95% credible interval [CrI]: 38, 84; P\u2010R, 43%; 95% CrI: 12, 78) and more achieved a reduction of \u226550% in uterine contractions in 6\u00a0h (R\u2010P, 63%; 95% CrI: 38, 84; P\u2010R, 29%; 95% CrI: 4, 64). The number of days to delivery was increased in women receiving R\u2010P (median 26\u00a0days for R\u2010P <jats:italic>vs.<\/jats:italic> 13\u00a0days for P\u2010R).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Intravenous retosiban has a favourable safety and tolerability profile and might prolong pregnancies in women with PTL. The study provides the rationale and dosing strategy for further evaluation of the efficacy of retosiban in the treatment of PTL.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.13336","type":"journal-article","created":{"date-parts":[[2017,5,30]],"date-time":"2017-05-30T03:52:37Z","timestamp":1496116357000},"page":"2283-2291","source":"Crossref","is-referenced-by-count":12,"title":["Treatment of spontaneous preterm labour with retosiban: a phase II pilot dose\u2010ranging study"],"prefix":"10.1111","volume":"83","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7613-0408","authenticated-orcid":false,"given":"Steven","family":"Thornton","sequence":"first","affiliation":[{"name":"Barts and the London School of Medicine and Dentistry Queen Mary University of London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guillermo","family":"Valenzuela","sequence":"additional","affiliation":[{"name":"Arrowhead Regional Medical Center  Colton CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charlotte","family":"Baidoo","sequence":"additional","affiliation":[{"name":"Quantitative Sciences, GSK  Uxbridge UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael J.","family":"Fossler","sequence":"additional","affiliation":[{"name":"Quantitative Sciences, GSK  Uxbridge UK"},{"name":"Quantitative Sciences, GSK  King of Prussia PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy H.","family":"Montague","sequence":"additional","affiliation":[{"name":"Quantitative Sciences, GSK  Uxbridge UK"},{"name":"Quantitative Sciences, GSK  King of Prussia PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linda","family":"Clayton","sequence":"additional","affiliation":[{"name":"GSK  Research Triangle Park NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcy","family":"Powell","sequence":"additional","affiliation":[{"name":"GSK  Research Triangle Park NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerry","family":"Snidow","sequence":"additional","affiliation":[{"name":"GSK  King of Prussia PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brendt","family":"Stier","sequence":"additional","affiliation":[{"name":"GSK  King of Prussia PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Soergel","sequence":"additional","affiliation":[{"name":"GSK  King of Prussia PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,7,11]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0b013e31825af2f0"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60136-1"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2008.08.020"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clp.2013.07.001"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.08.062554"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60820-4"},{"key":"e_1_2_9_8_1","unstructured":"March of Dimes 2015 premature birth report card. 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