{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T00:32:33Z","timestamp":1789518753241,"version":"build-2803163510"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,3,6]],"date-time":"2020-03-06T00:00:00Z","timestamp":1583452800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,3,6]],"date-time":"2020-03-06T00:00:00Z","timestamp":1583452800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"crossref","award":["OPPGH5295"],"award-info":[{"award-number":["OPPGH5295"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Merck for Mothers","award":["MISP 52110"],"award-info":[{"award-number":["MISP 52110"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Reprod Health"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>Oral tranexamic acid (TXA), if effective in reducing blood loss after delivery for women experiencing primary PPH, could be administered where parenteral administration is not feasible. This trial assessed the efficacy, safety, and acceptability of oral TXA when used as an adjunct to sublingual misoprostol to treat postpartum hemorrhage (PPH) following vaginal delivery.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>From October 2016 to January 2018, women presenting at four hospitals in Senegal and Vietnam for vaginal delivery were screened for enrollment in the trial. Women diagnosed with postpartum hemorrhage (defined as blood loss \u2265700\u2009ml) were randomized to receive either oral TXA (1950\u2009mg) or placebo in addition to 800 mcg sublingual misoprostol. Postpartum blood loss was measured using a calibrated drape. Blood loss for all PPH cases was recorded for 2 h after administration of the drugs. The primary outcome measure was the proportion of women with bleeding controlled with the trial regimen without recourse to further treatment. Secondary outcomes including the rate of severe PPH, mean\/median blood loss, use of additional uterotonics and\/or interventions side effects, and acceptability were also recorded.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>Of the 258 women who received treatment for PPH, 128 received placebo and misoprostol and 130 received TXA and misoprostol. The proportion of women who had active bleeding controlled with trial drugs alone and no additional interventions was similar in both groups: 77(60.2%) placebo; 74 (56.9%) TXA, <jats:italic>p<\/jats:italic>\u2009=\u20090.59). Use of other interventions to control bleeding, including uterotonics, did not differ significantly between groups. Median blood loss at PPH diagnosis was 700\u2009ml in both groups. Uterine atony alone or in addition to another cause contributed to over 90% of PPH cases reported (92.2% placebo vs. 91.5% TXA), other causes included perineal and cervical lacerations and retained placenta. Reports of side effects and acceptability were similar in the two groups.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Adjunct use of oral TXA with misoprostol to treat PPH resulted in similar clinical and acceptability outcomes when compared to treatment with misoprostol alone.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>This trial was registered with ClinicalTrials.gov, number <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02805426\">NCT02805426<\/jats:ext-link>. Registered on 3 September 2016.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s12978-020-0887-2","type":"journal-article","created":{"date-parts":[[2020,3,6]],"date-time":"2020-03-06T13:02:52Z","timestamp":1583499772000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["A double-blind, randomized controlled trial to explore oral tranexamic acid as adjunct for the treatment for postpartum hemorrhage"],"prefix":"10.1186","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7557-0863","authenticated-orcid":false,"given":"Ayisha","family":"Diop","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dina","family":"Abbas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nguyen thi Nhu","family":"Ngoc","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roxanne","family":"Martin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ange","family":"Razafi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hoang Thi Diem","family":"Tuyet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beverly","family":"Winikoff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,3,6]]},"reference":[{"key":"887_CR1","volume-title":"WHO recommendations for the prevention and treatment of postpartum haemorrhage. WHO Library Cataloguing-in-Publication Data NLM classification","author":"Department of Reproductive Health and Research. World Health Organization","year":"2012","unstructured":"Department of Reproductive Health and Research. World Health Organization. WHO recommendations for the prevention and treatment of postpartum haemorrhage. WHO Library Cataloguing-in-Publication Data NLM classification 2012."},{"key":"887_CR2","doi-asserted-by":"publisher","first-page":"217","DOI":"10.1016\/S0140-6736(09)61923-1","volume":"375","author":"J Blum","year":"2010","unstructured":"Blum J, Winikoff B, Raghavan S, et al. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial. Lancet. 2010;375:217\u201323.","journal-title":"Lancet"},{"key":"887_CR3","doi-asserted-by":"publisher","first-page":"210","DOI":"10.1016\/S0140-6736(09)61924-3","volume":"375","author":"B Winikoff","year":"2010","unstructured":"Winikoff B, Dabash R, Durocher J, et al. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial. Lancet. 2010;375:210\u20136.","journal-title":"Lancet"},{"key":"887_CR4","doi-asserted-by":"publisher","first-page":"1005","DOI":"10.2165\/00003495-199957060-00017","volume":"6","author":"CJ Dunn","year":"1999","unstructured":"Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999;6:1005\u201332.","journal-title":"Drugs"},{"key":"887_CR5","doi-asserted-by":"publisher","first-page":"463","DOI":"10.1007\/s00404-012-2593-y","volume":"287","author":"J Xu","year":"2013","unstructured":"Xu J, Gao W, Ju Y. Tranexamic acid for the prevention of postpartum hemorrhage after cesarean section: a double-blind randomization trial. Arch Gynecol Obstet. 2013;287:463\u20138.","journal-title":"Arch Gynecol Obstet"},{"key":"887_CR6","doi-asserted-by":"publisher","unstructured":"Henry DA, et al. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2011;(3):CD001886. https:\/\/doi.org\/10.1002\/14651858.CD001886.pub4.","DOI":"10.1002\/14651858.CD001886.pub4"},{"key":"887_CR7","doi-asserted-by":"publisher","first-page":"154","DOI":"10.1016\/S0301-2115(03)00287-2","volume":"112","author":"M Gai","year":"2004","unstructured":"Gai M, Wu L, Su Q, Tatsumoto K. Clinical observation of blood loss reduced by tranexamic acid during and after caesarian section: a multi-center, randomized trial. Eur J Obstet Gynaecol. 2004;112:154\u20137.","journal-title":"Eur J Obstet Gynaecol"},{"key":"887_CR8","doi-asserted-by":"publisher","first-page":"CD012964","DOI":"10.1002\/14651858.CD012964","volume":"2","author":"H Shakur","year":"2018","unstructured":"Shakur H, Beaumont D, Pavord S, Gayet-Ageron A, Ker K, Mousa HA. Antifibrinolytic drugs for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2018;2:CD012964. https:\/\/doi.org\/10.1002\/14651858.CD012964 Review.","journal-title":"Cochrane Database Syst Rev"},{"issue":"10084","key":"887_CR9","doi-asserted-by":"publisher","first-page":"2105","DOI":"10.1016\/S0140-6736(17)30638-4","volume":"389","author":"Haleema Shakur","year":"2017","unstructured":"WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017;389(10084):2105\u201316. https:\/\/doi.org\/10.1016\/S0140-6736(17)30638-4.","journal-title":"The Lancet"},{"key":"887_CR10","volume-title":"Updated WHO Recommendation on Tranexamic Acid for the Treatment of Postpartum Haemorrhage","author":"World Health Organization (WHO)","year":"2017","unstructured":"World Health Organization (WHO). Updated WHO Recommendation on Tranexamic Acid for the Treatment of Postpartum Haemorrhage. Geneva: WHO; 2017. Licence: CC BY-NC-SA 3.0 IGO. WHO\/RHR\/17.21."},{"issue":"11","key":"887_CR11","doi-asserted-by":"publisher","first-page":"1806","DOI":"10.1080\/14767058.2017.1418316","volume":"32","author":"Nahla W. Shady","year":"2017","unstructured":"Shady NW, Sallam HF, Elsayed AH, Abdelkader AM, Ali SS, Alanwar A, Abbas AM. The effect of prophylactic oral tranexamic acid plus buccal misoprostol on blood loss after vaginal delivery: a randomized controlled trial. J Matern Fetal Neonatal Med. 2017:1\u20137 doi: https:\/\/doi.org\/10.1080\/14767058.2017.1418316. [Epub ahead of print]. https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/29241383.","journal-title":"The Journal of Maternal-Fetal & Neonatal Medicine"},{"issue":"1","key":"887_CR12","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1007\/BF00554669","volume":"20","author":"Pibrant","year":"1981","unstructured":"Pibrant, et al. Pharmacokinetics and bioavailability of tranexamic acid. Eur J Clin Pharmacol. 1981;20(1):65\u201372.","journal-title":"Eur J Clin Pharmacol"},{"issue":"5","key":"887_CR13","first-page":"132","volume":"103","author":"JF Murphy","year":"2010","unstructured":"Murphy JF. Consort 2010 statement on randomised controlled trials. Ir Med J. 2010;103(5):132.","journal-title":"Ir Med J"},{"issue":"10116","key":"887_CR14","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1016\/S0140-6736(17)32455-8","volume":"391","author":"Ang\u00e8le Gayet-Ageron","year":"2018","unstructured":"Gayet-Ageron, et al. Effect of treatment delay on the effectiveness and safety of antifibrinolytics in acute severe haemorrhage: A meta-analysis of individual patient-level data from 40 138 bleeding patients. Lancet. 2017;391. https:\/\/doi.org\/10.1016\/S0140-6736(17)32455-8.","journal-title":"The Lancet"},{"key":"887_CR15","doi-asserted-by":"publisher","first-page":"1368","DOI":"10.1213\/ANE.0b013e3181d74898","volume":"110","author":"BT Bateman","year":"2010","unstructured":"Bateman BT, Berman MF, Riley LE, Leffert LR. The Epidemiology of Postpartum Hemorrhage in a Large, Nationwide Sample of Deliveries. Anesth Analg. 2010;110:1368\u201373. https:\/\/doi.org\/10.1213\/ANE.0b013e3181d74898.","journal-title":"Anesth Analg"}],"container-title":["Reproductive Health"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12978-020-0887-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s12978-020-0887-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12978-020-0887-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,3,6]],"date-time":"2021-03-06T00:46:00Z","timestamp":1614991560000},"score":1,"resource":{"primary":{"URL":"https:\/\/reproductive-health-journal.biomedcentral.com\/articles\/10.1186\/s12978-020-0887-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,3,6]]},"references-count":15,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["887"],"URL":"https:\/\/doi.org\/10.1186\/s12978-020-0887-2","relation":{},"ISSN":["1742-4755"],"issn-type":[{"value":"1742-4755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,3,6]]},"assertion":[{"value":"4 March 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 February 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 March 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The protocol was approved by National Council on Health Research, National Ethical Committee, Ministry of Health and Prevention, Senegal and in Vietnam; Ethics Committee in Biomedical Research of Hung Vuong Hospital and Ethics Committee in Biomedical Research of the National Hospital.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"34"}}