{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T05:07:26Z","timestamp":1764997646668,"version":"3.46.0"},"reference-count":78,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2024,9,27]],"date-time":"2024-09-27T00:00:00Z","timestamp":1727395200000},"content-version":"unspecified","delay-in-days":26,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Australian Medical Research Future Fund","award":["APP1199329"],"award-info":[{"award-number":["APP1199329"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,5,15]]},"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      We showed in a phase II randomised controlled trial (RCT) that oral sildenafil citrate in term labour halved operative birth for fetal distress. We outline the protocol for a phase III RCT (can\n                      <jats:italic>i<\/jats:italic>\n                      ntrapartum\n                      <jats:italic>S<\/jats:italic>\n                      ild\n                      <jats:italic>E<\/jats:italic>\n                      nafil safely\n                      <jats:italic>A<\/jats:italic>\n                      vert the\n                      <jats:italic>R<\/jats:italic>\n                      isks of\n                      <jats:italic>C<\/jats:italic>\n                      ontraction-induced\n                      <jats:italic>H<\/jats:italic>\n                      ypoxia? (iSEARCH)) of 3200 women in Australia to assess if sildenafil citrate reduces adverse perinatal outcomes related to intrapartum hypoxia.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>iSEARCH will enrol 3200 Australian women in term labour to determine whether up to three 50 mg oral doses of sildenafil citrate versus placebo reduce the relative risk of a primary composite end point of 10 perinatal outcomes potentially related to intrapartum hypoxia by 35% (from 7% to 4.55%). Secondary aims are to evaluate reductions in the relative risk of emergency caesarean section or instrumental vaginal birth for fetal distress by 25% (from 20% to 15%) and in healthcare costs. To detect a 35% reduction in the primary outcome for an alpha of 0.05 and power of 80% with 10% dropout in each arm requires 3200 women (1600 in each arm). This sample size will also yield &gt;90% power to detect a 25% reduction for the secondary outcome of any operative birth (caesarean section or instrumental vaginal birth) for fetal distress.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval for the iSEARCH RCT was granted by the Hunter New England Human Research Ethics Committee (ref no: 2020\/ETH02791). Results will be disseminated through websites, peer-reviewed publications, scientific meetings and social media, news outlets, television and radio.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ACTRN12621000231842.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-082943","type":"journal-article","created":{"date-parts":[[2024,9,29]],"date-time":"2024-09-29T01:50:48Z","timestamp":1727574648000},"page":"e082943","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["The iSEARCH randomised controlled trial protocol: a pragmatic Australian phase III clinical trial of intrapartum sildenafil citrate to improve outcomes potentially related to intrapartum hypoxia"],"prefix":"10.1136","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0832-4811","authenticated-orcid":false,"given":"Sailesh","family":"Kumar","sequence":"first","affiliation":[{"name":"Maternal & Fetal Medicine, Mater Medical Research Institute, South Brisbane, Queensland, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William","family":"Tarnow-Mordi","sequence":"additional","affiliation":[{"name":"NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8337-550X","authenticated-orcid":false,"given":"Ben W","family":"Mol","sequence":"additional","affiliation":[{"name":"OB\/GYN, Monash Medical School, Clayton, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vicki","family":"Flenady","sequence":"additional","affiliation":[{"name":"Mater Research Institute, The 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