{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T21:17:48Z","timestamp":1762377468296,"version":"3.37.3"},"reference-count":38,"publisher":"Public Library of Science (PLoS)","issue":"11","license":[{"start":{"date-parts":[[2023,11,15]],"date-time":"2023-11-15T00:00:00Z","timestamp":1700006400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","award":["NIHR300582"],"award-info":[{"award-number":["NIHR300582"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>OptiBreech collaborative care is a multi-disciplinary care pathway for breech presentation at term, with continuity from a breech specialist midwife, including where chosen, for vaginal breech birth (VBB). Pilot randomised trial using unblinded 1:1 parallel group allocation to OptiBreech versus standard care, within a cohort. Participants were women with a breech-presenting fetus &gt; 33 weeks, at four sites in England, January\u2013June 2022. A two-stage consent process was used. Participants consented to undergo random selection to be offered a \u2018new care process\u2019, with a choice to accept it, or not. Primary objectives were to identify recruitment, acceptance, and attrition rates. Randomisation procedures and potential primary outcomes for a substantive study were also feasibility-tested. 68 women were randomised between January\u2013June 2022. The consent process was acceptable to participants, but randomisation was unacceptable to women who specifically sought OptiBreech care. Two women withdrew due to concerns about sharing personal information. More women planned a VBB when randomised to OptiBreech Care (23.5% vs 0, p = .002, 95% CI = 9.3%,37.8%). Women randomised to OptiBreech care had: lower rates of cephalic presentation at birth (38.2% vs 54.5%), higher rates of vaginal birth (32.4% vs 24.2%), lower rates of in-labour caesarean birth (20.6% vs 36.4%), lower rates of neonatal intensive care (5.9% vs 9.1%), and lower rates of severe neonatal morbidity (2.9% vs 9.1%). Randomisation was stopped on the advice of the steering committee before the planned sample of 104, as lack of access to VBB within standard care prohibited comparison of outcomes. Demand for VBB is sufficient for a cohort study, but comparison of outcomes by 1:1 randomisation is not feasible. OptiBreech care would be best evaluated using stepped wedge cluster randomisation. Funded by the United Kingdom National Institute for Health and Care Research (NIHR300582). Clinical trial registration: ISRCTN 14521381.<\/jats:p>","DOI":"10.1371\/journal.pone.0294139","type":"journal-article","created":{"date-parts":[[2023,11,15]],"date-time":"2023-11-15T18:35:50Z","timestamp":1700073350000},"page":"e0294139","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":8,"title":["OptiBreech collaborative care versus standard care for women with a breech-presenting fetus at term: A pilot parallel group randomised trial to evaluate the feasibility of a randomised trial nested within a cohort"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3658-8988","authenticated-orcid":true,"given":"Shawn","family":"Walker","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6663-7093","authenticated-orcid":true,"given":"Emma","family":"Spillane","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kate","family":"Stringer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lauren","family":"Trepte","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Si\u00e2n M.","family":"Davies","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacana","family":"Bresson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Sandall","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Shennan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the OptiBreech Collaborative","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,11,15]]},"reference":[{"key":"pone.0294139.ref001","doi-asserted-by":"crossref","first-page":"596","DOI":"10.1111\/birt.12685","article-title":"Breech specialist midwives and clinics in the OptiBreech Trial feasibility study: An implementation process evaluation.","volume":"50","author":"T Dasgupta","year":"2023","journal-title":"Birth"},{"key":"pone.0294139.ref002","doi-asserted-by":"crossref","first-page":"202","DOI":"10.1111\/birt.12326","article-title":"Expertise in physiological breech birth: A mixed-methods study.","volume":"45","author":"S Walker","year":"2018","journal-title":"Birth"},{"key":"pone.0294139.ref003","doi-asserted-by":"crossref","first-page":"e170","DOI":"10.1016\/j.wombi.2017.09.008","article-title":"Deliberate acquisition of competence in physiological breech birth: A grounded theory study.","volume":"31","author":"S Walker","year":"2018","journal-title":"Women and Birth"},{"key":"pone.0294139.ref004","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1016\/j.midw.2016.01.007","article-title":"Standards for maternity care professionals attending planned upright breech births: A Delphi study.","volume":"34","author":"S Walker","year":"2016","journal-title":"Midwifery"},{"key":"pone.0294139.ref005","doi-asserted-by":"crossref","first-page":"558","DOI":"10.1111\/birt.12562","article-title":"Physiological breech birth training: An evaluation of clinical practice changes after a one\u2010day training program.","volume":"48","author":"S Mattiolo","year":"2021","journal-title":"Birth"},{"key":"pone.0294139.ref006","first-page":"25","article-title":"Physiological breech birth: Evaluation of a training programme for birth professionals.","volume":"20","author":"S Walker","year":"2017","journal-title":"Pract Midwife."},{"key":"pone.0294139.ref007","article-title":"Antenatal care.","author":"NICE","year":"2022","journal-title":"Clinical Guideline NG201"},{"key":"pone.0294139.ref008","first-page":"e151","article-title":"Management of Breech Presentation.","volume":"124","author":"on behalf of the Royal College of Obstetricians and Gynaecologists","year":"2017","journal-title":"BJOG"},{"volume-title":"NICE Guideline, CG190.","year":"2017","author":"NICE","key":"pone.0294139.ref009"},{"key":"pone.0294139.ref010","doi-asserted-by":"crossref","first-page":"1","DOI":"10.18332\/ejm\/143875","article-title":"Women\u2019s experiences of breech birth decision making: An integrated review.","volume":"6","author":"SE Morris","year":"2022","journal-title":"Eur J Midwifery"},{"key":"pone.0294139.ref011","doi-asserted-by":"crossref","first-page":"4","DOI":"10.3310\/nihropenres.13329.1","article-title":"What are women\u2019s experiences of seeking to plan a vaginal breech birth? 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