{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T06:31:35Z","timestamp":1790836295680,"version":"4.1.0"},"reference-count":18,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,6,1]],"date-time":"2015-06-01T00:00:00Z","timestamp":1433116800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2015,10]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>The aim was to investigate the efficacy and safety of intravenous retosiban in women with spontaneous preterm labour.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a randomized, double\u2010blind, placebo\u2010controlled, phase 2 trial. Retosiban was administered intravenously for 48\u2009h to women in spontaneous preterm labour between 30<jats:sup>0\/7<\/jats:sup> and 35<jats:sup>6\/7<\/jats:sup>\u2009weeks\u2019 gestation with an uncomplicated singleton pregnancy in an in\u2010patient obstetric unit. Outcome measures were uterine quiescence (primary endpoint), days to delivery, preterm delivery and safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Uterine quiescence was achieved in 62% of women who received retosiban (<jats:italic>n<\/jats:italic>\u2009=\u200930) compared with 41% who received placebo (<jats:italic>n<\/jats:italic>\u2009=\u200934). The relative risk (RR) was 1.53 (95% credible interval [CrI] 0.98, 2.48; NS). Retosiban resulted in a significant increase in time to delivery compared with placebo (mean difference 8.2\u2009days, 95% CrI 2.7, 13.74). This difference was consistent across all gestational ages. The proportion of preterm births in the retosiban and placebo groups was 18.7% (95% CrI 7.4%, 33.7%) and 47.2% (95% CrI 31.4%, 63.4%), respectively. The RR of preterm birth in women treated with retosiban was 0.38 (95% CrI 0.15, 0.81). There were no deliveries within 7\u2009days in the retosiban group, but there were six (17.6%) births in the placebo group. The maternal, fetal and neonatal adverse events were comparable in the retosiban and placebo groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Intravenous administration of retosiban in women with spontaneous preterm labour was associated with a greater than 1 week increase in time to delivery compared with placebo, a significant reduction in preterm deliveries, a non\u2010significant increase in uterine quiescence and a favourable safety profile.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.12646","type":"journal-article","created":{"date-parts":[[2015,3,27]],"date-time":"2015-03-27T22:30:01Z","timestamp":1427495401000},"page":"740-749","source":"Crossref","is-referenced-by-count":20,"title":["Treatment of spontaneous preterm labour with retosiban: a phase 2 proof\u2010of\u2010concept study"],"prefix":"10.1111","volume":"80","author":[{"given":"Steven","family":"Thornton","sequence":"first","affiliation":[{"name":"University of Exeter Medical School  Exeter UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugh","family":"Miller","sequence":"additional","affiliation":[{"name":"Watching Over Mothers and Babies Foundation  Tucson AZ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillermo","family":"Valenzuela","sequence":"additional","affiliation":[{"name":"Arrowhead Regional Medical Center  Colton CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerry","family":"Snidow","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Research Triangle Park NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brendt","family":"Stier","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Fossler","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy H.","family":"Montague","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcy","family":"Powell","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Research Triangle Park NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen J.","family":"Beach","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,6]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0b013e31825af2f0"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2007-2952"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.329.7467.675"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60136-1"},{"key":"e_1_2_10_6_1","unstructured":"Royal College of Obstetricians and Gynaecologists.Tocolytic drugs for women in preterm labour. 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