Extra-uterine placental transfusion and intact-cord stabilisation of infants in caesarean sections: An intervention development and pilot-study (INTACT-1)

Extra-uterine placental transfusion and intact-cord stabilisation of infants in caesarean sections: An intervention development and pilot-study (INTACT-1) | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Extra-uterine placental transfusion and intact-cord stabilisation of infants in caesarean sections: An intervention development and pilot-study (INTACT-1) Elisabeth Sæther, Ola Andersson, Solveig Bjellmo, Stine Bernitz, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3474426/v2 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 09 May, 2025 Read the published version in BMC Pregnancy and Childbirth → Version 2 posted 11 You are reading this latest preprint version Show more versions Abstract Background: Keeping the umbilical cord intact the first minutes after delivery is beneficial for both term and preterm infants. However, this may be challenging in caesarean sections (CS) due to lack of mobile resuscitation equipment, maintenance of sterility or concern for excessive maternal blood loss. The objective of this study was to develop and pilot-test extra-uterine placental transfusion and intact-cord stabilisation of infants in CS. Methods: The intervention development process (phase 1) covered: A) placenta delivery without cord clamping, B) intact-cord stabilisation of the infant and C) physiology-based cord clamping. Different scenarios were tested through in-situ simulation and adjusted through multiple feedback rounds. The involved staff were trained prior to pilot-testing (phase 2). Women having a CS in regional anaesthesia, expecting a term or near-term singleton infant were included in the pilot-study after written consent. Primary outcome was the proportion of successfully completed interventions. For assessment of safety, maternal estimated intraoperative blood loss, infant 5-minute Apgar scores and infant rectal temperature during stabilisation were compared to pre-defined accept criteria. Dry-electrode ECG (NeoBeat™) was used for early detection of infant heartrate. Any respiratory support was registered. Early skin-to-skin contact between mother and infant was attempted for vigorous infants. Results: A detailed intervention protocol was developed and tested. Twenty-nine mother-infant-dyads were included in the pilot study. Gestational age ranged from 37 to 42 weeks. The intervention was successfully completed in 26 of 29 cases, of which 31 % were planned CS. Median (SD) infant heart rates at one and five minutes were 159 (32) and 168 (21) beats per minute respectively. Eight infants (28%) had intact-cord respiratory support. One infant had a 5-minute Apgar score 1000 ml Conclusion: Extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for term and near-term infants delivered by CS was feasible according to predefined accept criteria. Further investigation of safety of this complex intervention in larger, comparative studies is warranted. Trial registration: Regional Committee for Medical Research Ethics Central Norway (REK-Midt), #399101 Umbilical cord clamping intact cord stabilisation placental transfusion infant caesarean section Figures Figure 1 Figure 2 Full Text Additional Declarations No competing interests reported. Supplementary Files Additionalfile1PRISMAflowdiagram.jpg Additionalfile2Teamsetupforemergencycaesareansection.jpg Additionalfile3Teamsetupforplannedcaesareansection.jpg Additionalfile4CliniciansexperienceswiththeINTACTintervention.jpg Additionalfile5ConsortflowdiagramINTACT1.jpg Additionalfile6GUIDEDChecklistINTACTintervention.pdf Additionalfile7TIDieRChecklistINTACTintervention.pdf Cite Share Download PDF Status: Published Journal Publication published 09 May, 2025 Read the published version in BMC Pregnancy and Childbirth → Version 2 posted Editorial decision: Accepted 21 Apr, 2025 Reviews received at journal 15 Apr, 2025 Reviews received at journal 26 Mar, 2025 Reviewers agreed at journal 24 Mar, 2025 Reviews received at journal 06 Mar, 2025 Reviewers agreed at journal 26 Feb, 2025 Reviewers agreed at journal 25 Feb, 2025 Reviewers invited by journal 25 Feb, 2025 Editor assigned by journal 23 Jan, 2025 Submission checks completed at journal 01 Aug, 2024 First submitted to journal 01 Aug, 2024 You are reading this latest preprint version Show more versions Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3474426","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":425112185,"identity":"45e9960d-fa92-11ef-91e4-06cc9d20a69f","order_by":0,"name":"Elisabeth 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(INTACT-1)","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-pregnancy-and-childbirth","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"prch","sideBox":"Learn more about [BMC Pregnancy and Childbirth](http://bmcpregnancychildbirth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/prch/default.aspx","title":"BMC Pregnancy and Childbirth","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC 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However, this may be challenging in caesarean sections (CS) due to lack of mobile resuscitation equipment, maintenance of sterility or concern for excessive maternal blood loss. The objective of this study was to develop and pilot-test extra-uterine placental transfusion and intact-cord stabilisation of infants in CS.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e The intervention development process (phase 1) covered: A) placenta delivery without cord clamping, B) intact-cord stabilisation of the infant and C) physiology-based cord clamping. Different scenarios were tested through in-situ simulation and adjusted through multiple feedback rounds. The involved staff were trained prior to pilot-testing (phase 2). Women having a CS in regional anaesthesia, expecting a term or near-term singleton infant were included in the pilot-study after written consent. Primary outcome was the proportion of successfully completed interventions. For assessment of safety, maternal estimated intraoperative blood loss, infant 5-minute Apgar scores and infant rectal temperature during stabilisation were compared to pre-defined accept criteria. Dry-electrode ECG (NeoBeat™) was used for early detection of infant heartrate. Any respiratory support was registered. Early skin-to-skin contact between mother and infant was attempted for vigorous infants.\u003cbr\u003e\n \u003cstrong\u003eResults:\u003c/strong\u003e A detailed intervention protocol was developed and tested. Twenty-nine mother-infant-dyads were included in the pilot study. Gestational age ranged from 37 to 42 weeks. The intervention was successfully completed in 26 of 29 cases, of which 31 % were planned CS. Median (SD) infant heart rates at one and five minutes were 159 (32) and 168 (21) beats per minute respectively. Eight infants (28%) had intact-cord respiratory support. One infant had a 5-minute Apgar score \u0026lt; 7 and three infants (10%) had rectal temperatures below 36.5°C during the first 10-15 minutes after birth. Three mothers (10%) had estimated intraoperative blood loss \u0026gt; 1000 ml\u003cbr\u003e\n \u003cstrong\u003eConclusion:\u003c/strong\u003e Extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for term and near-term infants delivered by CS was feasible according to predefined accept criteria. Further investigation of safety of this complex intervention in larger, comparative studies is warranted.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration: \u003c/strong\u003eRegional Committee for Medical Research Ethics Central Norway (REK-Midt), #399101\u003c/p\u003e","manuscriptTitle":"Extra-uterine placental transfusion and intact-cord stabilisation of infants in caesarean sections: An intervention development and pilot-study (INTACT-1)","msid":"","msnumber":"","nonDraftVersions":[{"code":2,"date":"2025-03-06 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