{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T23:45:10Z","timestamp":1793231110713,"version":"4.5.0"},"reference-count":10,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T00:00:00Z","timestamp":1711497600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T00:00:00Z","timestamp":1711497600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100003491","name":"Herlev Hospital","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003491","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001734","name":"Copenhagen University","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100001734","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Approximately 85% of women experience an obstetric tear at delivery and up to 25% subsequently experience wound dehiscence and\/or infection. Previous publications suggest that intravenous antibiotics administrated during delivery reduces this risk. We do not know if oral antibiotics given after delivery can reduce the risk of wound dehiscence or infection. Our aim is to investigate whether three doses of oral antibiotics (amoxicillin 500\u00a0mg\/clavulanic acid 125\u00a0mg) given after delivery can reduce the risk of wound dehiscence and infection in patients with a second-degree obstetric tear or episiotomy.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We will perform a randomized, controlled, double-blinded study including 221women in each arm with allocation 1:1 in relation to the randomization. The study is carried out at Department of Obstetrics &amp; Gynecology, Herlev University Hospital, Copenhagen, Denmark. The women will be included after delivery if they have had a second-degree tear or episiotomy. After inclusion, the women will have a clinical follow-up visit after 1\u00a0week. The tear and healing will be evaluated regarding signs of infection and\/or dehiscence. The women will again be invited for a 1-year clinical examination including ultrasound. Questionnaires exploring symptoms related to the obstetric tear and possible complications will be answered at both visits. Our primary outcome is wound dehiscence and\/or wound infection, which will be calculated using <jats:italic>\u03c7<\/jats:italic><jats:sup>2<\/jats:sup> tests to compare groups. Secondary outcomes are variables that relate to wound healing, as pain, use of painkillers and antibiotics, need for further follow-up, as well as outcomes that may be related to the birth or healing process, urinary or anal incontinence, symptoms of prolapse, female body image, and sexual problems.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>Reducing the risk of wound dehiscence and\/or infection would decrease the number of control visits, prevent the need for longer antibiotic treatment, and possibly also decrease both short-term and long-term symptoms. This would be of great importance so the mother, her partner, and the baby could establish and optimize their initial family relation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>The conduction of this study is approved the 2\/2\u20132023 with the EU-CT number: 2022\u2013501930-49\u201300. ClinicalTrials.gov Identifier: NCT05830162.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-08069-x","type":"journal-article","created":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T03:02:02Z","timestamp":1711508522000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["The REPAIR study: oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear\u2014a double-blinded placebo controlled randomized trial"],"prefix":"10.1186","volume":"25","author":[{"given":"Kathrine","family":"Perslev","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niels","family":"Klarskov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Bergholt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0224-1425","authenticated-orcid":false,"given":"Hanna","family":"Jang\u00f6","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,3,27]]},"reference":[{"key":"8069_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.ejogrb.2019.05.038","volume":"240","author":"K Jones","year":"2019","unstructured":"Jones K, Webb S, Manresa M, Hodgetts-Morton V, Morris RKK. The incidence of wound infection and dehiscence following childbirth-related perineal trauma: a systematic review of the evidence. Eur J Obstet Gynecol Reprod Biol. 2019;240:1\u20138.","journal-title":"Eur J Obstet Gynecol Reprod Biol"},{"issue":"1","key":"8069_CR2","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1046\/j.1523-536x.1999.00011.x","volume":"26","author":"L Albers","year":"1999","unstructured":"Albers L, Garcia J, Renfrew M, McCandlish R, Elbourne D. Distribution of genital tract trauma in childbirth and related postnatal pain. Birth. 1999;26(1):11\u20137.","journal-title":"Birth"},{"issue":"1","key":"8069_CR3","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1007\/s00404-019-05165-1","volume":"300","author":"D Gommesen","year":"2019","unstructured":"Gommesen D, Nohr EA, Drue HC, Qvist N, Rasch V. Obstetric perineal tears: risk factors, wound infection and dehiscence: a prospective cohort study. Arch Gynecol Obstet. 2019;300(1):67\u201377.","journal-title":"Arch Gynecol Obstet"},{"issue":"3","key":"8069_CR4","doi-asserted-by":"publisher","first-page":"128","DOI":"10.1016\/0196-6553(88)90053-3","volume":"16","author":"JS Garner","year":"1988","unstructured":"Garner JS, Jarvis WR, Emori TGG, Horan TC, Hughes JM. CDC definitions for nosocomial infections, 1988. Am J Infect Control. 1988;16(3):128\u201340.","journal-title":"Am J Infect Control"},{"issue":"10189","key":"8069_CR5","doi-asserted-by":"publisher","first-page":"2395","DOI":"10.1016\/S0140-6736(19)30773-1","volume":"393","author":"M Knight","year":"2019","unstructured":"Knight M, Chiocchia V, Partlett C, Rivero-Arias O, Hua X, Hinshaw K, et al. Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial. Lancet North Amer. 2019;393(10189):2395\u2013403.","journal-title":"Lancet North Amer"},{"issue":"346","key":"8069_CR6","doi-asserted-by":"publisher","first-page":"e7586","DOI":"10.1136\/bmj.e7586","volume":"8","author":"AW Chan","year":"2013","unstructured":"Chan AW, Tetzlaff JM, G\u00f8tzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;8(346):e7586.","journal-title":"BMJ"},{"key":"8069_CR7","unstructured":"Region Stockholm S. Janusmed.se. Available from: https:\/\/janusmed.se\/amning?nplIds=20100807000020"},{"issue":"6","key":"8069_CR8","doi-asserted-by":"publisher","first-page":"1567","DOI":"10.1007\/s00192-021-05029-w","volume":"33","author":"H Dahlgren","year":"2022","unstructured":"Dahlgren H, Jansson MH, Franz\u00e9n K, Hiyoshi A, Nilsson K. Sexual function in primiparous women: a prospective study. Int Urogynecol J. 2022;33(6):1567\u201382.","journal-title":"Int Urogynecol J"},{"issue":"6","key":"8069_CR9","doi-asserted-by":"publisher","first-page":"1567","DOI":"10.1007\/s00192-021-05029-w","volume":"33","author":"H Dahlgren","year":"2022","unstructured":"Dahlgren H, Jansson MH, Franz\u00e9n K, Hiyoshi A, Nilsson K. Sexual function in primiparous women: a prospective study. Int Urogynecology J. 2022;33(6):1567\u201382.","journal-title":"Int Urogynecology J"},{"issue":"4","key":"8069_CR10","doi-asserted-by":"publisher","first-page":"1199","DOI":"10.1016\/j.ajog.2004.02.064","volume":"191","author":"AJ Macarthur","year":"2004","unstructured":"Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004;191(4):1199\u2013204.","journal-title":"Am J Obstet Gynecol"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08069-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-024-08069-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08069-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T14:12:39Z","timestamp":1711548759000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-024-08069-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,27]]},"references-count":10,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["8069"],"URL":"https:\/\/doi.org\/10.1186\/s13063-024-08069-x","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3,27]]},"assertion":[{"value":"7 August 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 March 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 March 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study has been approved through the new European CTIS, where it has been approved by both the scientific ethics committee in Denmark and the Danish Medicines Agency (see Additional file ). Written, informed consent to participate will be obtained from all participants. The primary investigator will update the rest of the research group on a daily to weekly basis depending on the situation. The study will further be monitored by the GCP unit and reported to the region\u2019s data registration system Pactius. Any important changes to the protocol will be reported to the GCP-unit and CTIS for approval.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable\u2014no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"221"}}