{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T01:57:39Z","timestamp":1774403859180,"version":"3.50.1"},"reference-count":31,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2022,5,4]],"date-time":"2022-05-04T00:00:00Z","timestamp":1651622400000},"content-version":"unspecified","delay-in-days":3,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015652","name":"Barts Charity","doi-asserted-by":"publisher","award":["MGU0371"],"award-info":[{"award-number":["MGU0371"]}],"id":[{"id":"10.13039\/100015652","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,3,11]]},"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The ACROBAT pilot trial of early cryoprecipitate for severe postpartum haemorrhage used deferred consent procedures. Pretrial discussions with a patient and public involvement group found mixed views towards deferred consent. This study aimed to build an understanding of how the deferred consent procedures worked in practice, to inform plans for a full-scale trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Qualitative interview study within a cluster-randomised pilot trial, involving four London maternity services.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Individual interviews were conducted postnatally with 10\u2009women who had received blood transfusion for severe postpartum haemorrhage and had consented to the trial. We also interviewed four \u2018recruiters\u2019\u2014two research midwives and two clinical trials practitioners who conducted trial recruitment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Consent procedures in the ACROBAT pilot trial were generally acceptable and the intervention was viewed as low risk, but most women did not remember much about the consent conversation. As per trial protocol, recruiters sought to consent women before hospital discharge, but this time pressure had to be balanced against the need to ensure women were not approached when distressed or very unwell. Extra efforts had to be made to communicate trial information to women due to the exhaustion of their recovery and competing demands for their attention. Participant information was further complicated by explanations about the cluster design and change in transfusion process, even though the consent sought was for access to medical data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Our findings indicate that deferred consent procedures raise similar concerns as taking consent when emergency obstetric research is occurring\u2014that is, the risk that participants may conflate research with clinical care, and that their ability to process trial information may be impacted by the stressful nature of recovery and newborn care. A future trial may support more meaningful informed consent by extending the window of consent discussion and ensuring trial information is minimal and easy to understand.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN12146519\">ISRCTN12146519<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-054787","type":"journal-article","created":{"date-parts":[[2022,5,4]],"date-time":"2022-05-04T12:30:17Z","timestamp":1651667417000},"page":"e054787","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Deferred consent in emergency obstetric research: findings from qualitative interviews with women and recruiters in the\n                    <i>ACROBAT<\/i>\n                    pilot trial for severe postpartum haemorrhage"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"isrctn12146519","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1630-467X","authenticated-orcid":false,"given":"Lorna","family":"Sweeney","sequence":"first","affiliation":[{"name":"Centre for Effective Services, Dublin 2, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Doris","family":"Lanz","sequence":"additional","affiliation":[{"name":"Barts Research Centre for Women's Health, Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5816-2609","authenticated-orcid":false,"given":"Jahnavi","family":"Daru","sequence":"additional","affiliation":[{"name":"Barts Research Centre for Women's Health, Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annika M P","family":"Rasijeff","sequence":"additional","affiliation":[{"name":"Blizard Institute, Queen Mary University of London, London, UK"},{"name":"Katie\u2019s Team Patient and Public Advisory Group, Barts Research Centre for Women\u2019s Health, Queen Mary University of London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Farzana","family":"Khanom","sequence":"additional","affiliation":[{"name":"Katie\u2019s Team Patient and Public Advisory Group, Barts Research Centre for Women\u2019s Health, Queen Mary University of London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy","family":"Thomas","sequence":"additional","affiliation":[{"name":"Barts Health NHS Trust, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela","family":"Harden","sequence":"additional","affiliation":[{"name":"School of Health Sciences, City University of London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4063-9768","authenticated-orcid":false,"given":"Laura","family":"Green","sequence":"additional","affiliation":[{"name":"Blizard Institute, Queen Mary University of London, London, UK"},{"name":"Barts Health NHS Trust, London, UK"},{"name":"NHS Blood and Transplant, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,5,4]]},"reference":[{"key":"2025121514175472000_12.5.e054787.1","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1111\/1471-0528.16379","article-title":"Predicting risk of postpartum haemorrhage: a systematic review","volume":"128","author":"Neary","year":"2021","journal-title":"BJOG"},{"key":"2025121514175472000_12.5.e054787.2","unstructured":"The medicines for human use (clinical trials) regulations, 2004. Available: www.legislation.gov.uk\/uksi\/2004\/1031 [Accessed 24 Jan 2022]."},{"key":"2025121514175472000_12.5.e054787.3","doi-asserted-by":"crossref","first-page":"107","DOI":"10.4103\/picr.PICR_147_16","article-title":"Informed consent process: a step further towards making it meaningful!","volume":"8","author":"Kadam","year":"2017","journal-title":"Perspect Clin Res"},{"key":"2025121514175472000_12.5.e054787.4","unstructured":"Kenyon S , Ewer A . Clinical governance advice no. 6a. 2. Obtaining Valid Consent to Participate in Perinatal Research Where Consent is Time Critical. London: Royal College of Obstetricians & Gynaecologists, 2016."},{"key":"2025121514175472000_12.5.e054787.5","doi-asserted-by":"crossref","first-page":"800","DOI":"10.1016\/j.midw.2011.11.009","article-title":"Views of emergency research (vera): a qualitative study of women and their partners' views of recruitment to trials in severe postpartum haemorrhage","volume":"28","author":"Snowdon","year":"2012","journal-title":"Midwifery"},{"key":"2025121514175472000_12.5.e054787.6","doi-asserted-by":"crossref","first-page":"1744","DOI":"10.1111\/1471-0528.15333","article-title":"What women think about consent to research at the time of an obstetric emergency: a qualitative study of the views of a cohort of World maternal antifibrinolytic trial participants","volume":"125","author":"Houghton","year":"2018","journal-title":"BJOG"},{"key":"2025121514175472000_12.5.e054787.7","doi-asserted-by":"crossref","DOI":"10.1186\/s12910-017-0196-7","article-title":"Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting","volume":"18","author":"Lawton","year":"2017","journal-title":"BMC Med Ethics"},{"key":"2025121514175472000_12.5.e054787.8","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-017-1940-5","article-title":"Clinicians' views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study","volume":"18","author":"Chhoa","year":"2017","journal-title":"Trials"},{"key":"2025121514175472000_12.5.e054787.9","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2017-018562"},{"key":"2025121514175472000_12.5.e054787.10","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6939-14-45"},{"key":"2025121514175472000_12.5.e054787.11","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1111\/1742-6723.12958","article-title":"Community attitudes to emergency research without prospective informed consent: a survey of the general population","volume":"30","author":"Furyk","year":"2018","journal-title":"Emerg Med Australas"},{"key":"2025121514175472000_12.5.e054787.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.socscimed.2008.10.001"},{"key":"2025121514175472000_12.5.e054787.13","doi-asserted-by":"publisher","DOI":"10.1016\/j.annemergmed.2008.07.021"},{"key":"2025121514175472000_12.5.e054787.14","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2015-008522"},{"key":"2025121514175472000_12.5.e054787.15","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0035982"},{"key":"2025121514175472000_12.5.e054787.16","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2015-309245"},{"key":"2025121514175472000_12.5.e054787.17","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1111\/anae.15595","article-title":"Early cryoprecipitate transfusion versus standard care in severe postpartum haemorrhage: a pilot cluster-randomised trial","volume":"77","author":"Green","year":"2022","journal-title":"Anaesthesia"},{"key":"2025121514175472000_12.5.e054787.18","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2019-036416"},{"key":"2025121514175472000_12.5.e054787.19","doi-asserted-by":"crossref","first-page":"362","DOI":"10.1111\/1471-0528.14419","article-title":"Involving pregnant women, mothers and members of the public to improve the quality of women's health research","volume":"124","author":"Moss","year":"2017","journal-title":"BJOG"},{"key":"2025121514175472000_12.5.e054787.20","doi-asserted-by":"crossref","unstructured":"Lanz D , Moore P , Daru J . Consent in obstetric emergency research - there is yet more to learn. BJOG 1754;2018.","DOI":"10.1111\/1471-0528.15340"},{"key":"2025121514175472000_12.5.e054787.21","doi-asserted-by":"publisher","DOI":"10.1191\/1478088706qp063oa"},{"key":"2025121514175472000_12.5.e054787.22","doi-asserted-by":"crossref","DOI":"10.1186\/s12884-016-0870-7","article-title":"Women and their birth partners' experiences following a primary postpartum haemorrhage: a qualitative study","volume":"16","author":"Dunning","year":"2016","journal-title":"BMC Pregnancy Childbirth"},{"key":"2025121514175472000_12.5.e054787.23","doi-asserted-by":"crossref","first-page":"791","DOI":"10.1016\/j.midw.2011.12.012","article-title":"Information-hungry and disempowered: a qualitative study of women and their partners' experiences of severe postpartum haemorrhage","volume":"28","author":"Snowdon","year":"2012","journal-title":"Midwifery"},{"key":"2025121514175472000_12.5.e054787.24","doi-asserted-by":"crossref","first-page":"350","DOI":"10.1016\/j.wombi.2017.12.009","article-title":"Facilitators and barriers to pregnant women's participation in research: a systematic review","volume":"31","author":"van der Zande","year":"2018","journal-title":"Women Birth"},{"key":"2025121514175472000_12.5.e054787.25","doi-asserted-by":"crossref","first-page":"476","DOI":"10.1111\/bioe.12361","article-title":"The experiences of pregnant women in an interventional clinical trial: research in pregnancy ethics (ripe) study","volume":"31","author":"Ballantyne","year":"2017","journal-title":"Bioethics"},{"key":"2025121514175472000_12.5.e054787.26","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0040324"},{"key":"2025121514175472000_12.5.e054787.27","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0184224","article-title":"Reducing therapeutic misconception: a randomized intervention trial in hypothetical clinical trials","volume":"12","author":"Christopher","year":"2017","journal-title":"PLoS One"},{"key":"2025121514175472000_12.5.e054787.28","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2393-14-221","article-title":"A longitudinal study of women's memories of their childbirth experiences at five years postpartum","volume":"14","author":"Takehara","year":"2014","journal-title":"BMC Pregnancy Childbirth"},{"key":"2025121514175472000_12.5.e054787.29","doi-asserted-by":"publisher","DOI":"10.1136\/jme.2005.013722"},{"key":"2025121514175472000_12.5.e054787.30","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0234783","article-title":"Recruiters' perspectives of recruiting women during pregnancy and childbirth to clinical trials: a qualitative evidence synthesis","volume":"15","author":"Hanrahan","year":"2020","journal-title":"PLoS One"},{"key":"2025121514175472000_12.5.e054787.31","unstructured":"Ribbens McCarthy J . Young people\u2019s experiences of loss and bereavement: Towards an interdisciplinary perspective. UK: Open University Press, 2006."}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-054787","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T22:18:06Z","timestamp":1765837086000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-054787"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5]]},"references-count":31,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2022,5,4]]},"published-print":{"date-parts":[[2022,5]]}},"alternative-id":["10.1136\/bmjopen-2021-054787"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-054787","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5]]}}}