{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T16:53:03Z","timestamp":1792601583041,"version":"4.5.0"},"reference-count":17,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,10,8]],"date-time":"2019-10-08T00:00:00Z","timestamp":1570492800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"publisher","award":["PB\u2010PG\u20101215\u201020013"],"award-info":[{"award-number":["PB\u2010PG\u20101215\u201020013"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Obstet Gynecol Scand"],"published-print":{"date-parts":[[2020,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Cesarean sections are the most common major operation worldwide. One in 10 women develops a surgical\u2010site infection after cesarean section. The PREPS pilot trial was developed to assess the feasibility of a randomized controlled trial of vaginal cleansing with chlorhexidine before cesarean section, to reduce infectious morbidity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Material and methods<\/jats:title><jats:p>A multi\u2010center, open\u2010label, parallel\u2010group pilot randomized controlled trial across 4 UK maternity units. Women aged \u226516\u00a0years, undergoing elective or emergency cesarean section, \u226534\u00a0weeks of gestation, and able to give informed consent were eligible. Women were randomized 1:1 to chlorhexidine 0.05% or no cleansing and were followed up until 6\u00a0weeks after cesarean section. The feasibility of a larger randomized controlled trial was assessed by the pilot trial\u2019s recruitment, ability to use verbal consent in an emergency, adherence, follow\u2010up and withdrawal rates. The main clinical outcome collected was Center for Disease Control and Prevention (CDC) classification of endometritis at 30\u00a0days. Trial registration number is ISRCTN33435996.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 320 women (128% of target) were randomized. Of these, 93% (95% CI 89%\u201095%) received their allocated intervention. Of the 88 women who had an emergency cesarean section, verbal consent was initially given by 32 (36%) women, with the remainder having sufficient time to give written consent. Endometritis (CDC definition) was collected from medical notes of 96% of women, 68% (95% CI 63%\u201073%) were followed up at both 14 and 30\u00a0days by telephone, and we were able to collect patient\u2010reported outcomes. In the vaginal cleansing arm 2\/152 (1.3%) women had endometritis compared with 1\/155 (0.7%) in the no cleansing arm (RR 2.08, 95% CI 0.19\u201022.31).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>It is possible to perform a randomized controlled trial in women undergoing an elective or emergency cesarean section, using a verbal\u2010followed\u2010by\u2010written consent process, while maintaining high adherence and retaining women in the trial.<\/jats:p><\/jats:sec>","DOI":"10.1111\/aogs.13737","type":"journal-article","created":{"date-parts":[[2019,9,20]],"date-time":"2019-09-20T13:35:13Z","timestamp":1568986513000},"page":"231-239","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Vaginal preparation with chlorhexidine at cesarean section to reduce endometritis and prevent sepsis: A randomized pilot trial (PREPS)"],"prefix":"10.1111","volume":"99","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9817-4313","authenticated-orcid":false,"given":"Victoria","family":"Hodgetts-Morton","sequence":"first","affiliation":[{"name":"Birmingham Women\u2019s and Children\u2019s Hospital NHS Foundation Trust Birmingham UK"},{"name":"Institute of Metabolism and Systems Research University of Birmingham Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine A.","family":"Hewitt","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit Institute of Applied Health Research University of Birmingham Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amie","family":"Wilson","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit Institute of Applied Health Research University of Birmingham Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0321-7868","authenticated-orcid":false,"given":"Nicola","family":"Farmer","sequence":"additional","affiliation":[{"name":"Birmingham Women\u2019s and Children\u2019s Hospital NHS Foundation Trust Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annalise","family":"Weckesser","sequence":"additional","affiliation":[{"name":"Center for Social Care, Health and Related Research Faculty of Health, Education and Life Sciences Birmingham City University, City South Campus Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Dixon","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit Institute of Applied Health Research University of Birmingham Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9950-6751","authenticated-orcid":false,"given":"Peter","family":"Brocklehurst","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit Institute of Applied Health Research University of Birmingham Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pollyanna","family":"Hardy","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit Institute of Applied Health Research University of Birmingham Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1247-429X","authenticated-orcid":false,"given":"Rachel K.","family":"Morris","sequence":"additional","affiliation":[{"name":"Birmingham Women\u2019s and Children\u2019s Hospital NHS Foundation Trust Birmingham UK"},{"name":"Institute of Metabolism and Systems Research University of Birmingham Birmingham UK"},{"name":"Birmingham Clinical Trials Unit Institute of Applied Health Research University of Birmingham Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,10,8]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"NHS Maternity Statistics, England 2017\u201318","author":"Digital N","year":"2018"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1471-0528.2012.03452.x"},{"key":"e_1_2_9_4_1","first-page":"CD009516","article-title":"Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery","volume":"12","author":"Mackeen AD","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_9_5_1","unstructured":"Centre for Disease Control and Prevention (CDC).National Healthcare Safety Network (NHSN) Patient Safety Component Manual 2018.https:\/\/www.cdc.gov\/nhsn\/pdfs\/pscmanual\/pcsmanual_current.pdf. Accessed October 24 2018."},{"key":"e_1_2_9_6_1","unstructured":"KnightM NairM TuffnellD ShakespeareJ KenyonS KurinczukJJ eds.;on behalf of MBRRACE\u2010UK.Saving Lives Improving Mothers\u2019 Care\u2014Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2013\u201315.Oxford:National Perinatal Epidemiology Unit University of Oxford;2017."},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000002167"},{"key":"e_1_2_9_8_1","unstructured":"National Institute for Health and Care Excellence (NICE).Caesarean section Clinical Guideline (CG132).2012.https:\/\/www.nice.org.uk\/guidance\/cg132. Accessed October 24 2018."},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF03347188"},{"key":"e_1_2_9_10_1","first-page":"486","article-title":"Preoperative vaginal preparation using povidone iodine versus chlorhexidine solutions in prevention of endometritis in elective cesarean section","volume":"4","author":"Tewfik H","year":"2015","journal-title":"Int J Curr Microbiol App Sci"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12884-019-2402-8"},{"key":"e_1_2_9_12_1","first-page":"411","article-title":"Pilot studies","volume":"17","author":"Connelly LM","year":"2008","journal-title":"Medsurg Nurs"},{"key":"e_1_2_9_13_1","doi-asserted-by":"crossref","unstructured":"Joint Formulary Committee.Chlorhexidine. British National Formulary 2018.https:\/\/doi.org\/10.18578\/BNF.534548697.","DOI":"10.18578\/BNF.534548697"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40814-018-0273-9"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0039-1681095"},{"key":"e_1_2_9_16_1","unstructured":"Centre for Disease Control and Prevention (CDC).CDC\/NHSN Surveillance Definitions for Specific Types of Infections.Washington DC CDC 2018."},{"key":"e_1_2_9_17_1","unstructured":"National Institute for Health and Care Excellence (NICE).Sepsis Guideline[NG51].2017.https:\/\/www.nice.org.uk\/guidance\/ng51."},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1080\/00016340701515225"}],"container-title":["Acta Obstetricia et Gynecologica Scandinavica"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/aogs.13737","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/aogs.13737","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/aogs.13737","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T20:21:20Z","timestamp":1694118080000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1111\/aogs.13737"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10,8]]},"references-count":17,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,2]]}},"alternative-id":["10.1111\/aogs.13737"],"URL":"https:\/\/doi.org\/10.1111\/aogs.13737","archive":["Portico"],"relation":{},"ISSN":["0001-6349","1600-0412"],"issn-type":[{"value":"0001-6349","type":"print"},{"value":"1600-0412","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,10,8]]},"assertion":[{"value":"2019-06-25","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-09-17","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-10-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}