[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648867":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":44,"locations":53,"responsibleParty":68,"collaborators":71,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":48,"enrollmentInfo":90,"targetDuration":48,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":112,"whyStopped":48,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal Saline","PLACEBO_COMPARATOR","Participants will receive a single local perineal injection of 4-5 mL of 0.9% sodium chloride solution during primary repair of a second-degree or more severe perineal tear and\u002For episiotomy, after closure of the deeper layers and before skin closure.",[13],"Drug: Saline (0.9%, sterile, for infusion)",{"label":15,"type":16,"description":17,"interventionNames":18},"Autologous Platelet-Rich Plasma","EXPERIMENTAL","Participants will receive a single local perineal injection of 4-5 mL of autologous non-activated platelet-rich plasma during primary repair of a second-degree or more severe perineal tear and\u002For episiotomy, after closure of the deeper layers and before skin closure.",[19],"Biological: Autologous Non-Activated Platelet-Rich Plasma",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Autologous Non-Activated Platelet-Rich Plasma","Autologous non-activated platelet-rich plasma will be prepared from venous blood using the RegenBCT-3 system. Approximately 4-5 mL will be injected locally into the subcutaneous and mucosal tissues of the perineal wound using a 27-gauge needle, with approximately 0.1 mL administered at each injection point spaced approximately 5-10 mm apart on both sides of the wound. The intervention will be administered once, within 5 hours after vaginal birth, after closure of the deeper layers and before skin closure.",[15],[27,28,29],"RegenPRP","RegenBCT-3","PRP",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Saline (0.9%, sterile, for infusion)","Approximately 4-5 mL of sterile 0.9% sodium chloride solution will be injected locally into the subcutaneous and mucosal tissues of the perineal wound using the same injection technique, volume, timing, and anatomical distribution as the experimental intervention. The injection will be administered once, within 5 hours after vaginal birth, after closure of the deeper layers and before skin closure.",[9],[36],"Normal saline",[38,41],{"name":39,"affiliation":5,"role":40},"Océane Pécheux, Dr","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":5,"role":43},"Jasmine Abdulcadir, PD","STUDY_DIRECTOR",[45,50],{"name":39,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","+41 79 553 50 95",null,"oceane.pecheux@hug.ch",{"name":51,"role":46,"phone":48,"phoneExt":48,"email":52},"Ketty Hu, Dr","ketty.hu@hug.ch",[54],{"facility":5,"status":48,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Geneva","Canton of Geneva","1205","Switzerland","CH",{"type":61,"coordinates":62},"Point",[63,64],6.14569,46.20222,{"lat":64,"lon":63},[67],{"name":39,"role":46,"phone":47,"phoneExt":48,"email":49},{"type":40,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Océane Pécheux","Principal investigator",[72,75,78],{"name":73,"class":74},"University Hospitals of Geneva","UNKNOWN",{"name":76,"class":77},"Regen Lab SA","INDUSTRY",{"name":79,"class":74},"Fondation Ernst et Lucie Schmidheiny","100648867","relieve-study--platelet-rich-plasma-to-reduce-postpartum-pain-after-perineal-tears-or-episiotomy-100648867",false,"NCT07727213","RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy","RELIEVE Study (REducing Labour-Induced Episiotomy and Vaginal Tear Pain Using Platelet Rich Plasma (PRP) for Enhanced Healing): A Triple-blind, Randomised, Placebo-controlled Trial Assessing PRP for Reducing Postpartum Pain After Perineal Tears or Episiotomies.","RELIEVE","Inclusion Criteria:\n\n* Age 18 years or older\n* Vaginal birth with a second-degree or more severe perineal tear and\u002For an episiotomy\n* Written informed consent obtained before any study-specific procedure\n\nExclusion Criteria:\n\n* Refusal to participate or lack of decision-making capacity at the time of consent\n* Inability to ensure an adequately informed consent process despite appropriate support measures, including adapted oral information and, when required, faithful translation or assistance from a professional interpreter\n* Clinically significant hereditary or acquired coagulation disorder, including platelet count below 100 × 10\\^9\u002FL, international normalized ratio above 1.5, activated partial thromboplastin time above 1.5 times the upper limit of normal, congenital coagulation factor deficiency, von Willebrand disease, or prophylactic or therapeutic anticoagulation administered less than 24 hours before venous blood sampling for PRP preparation\n* Aspirin or clopidogrel taken within 7 days before venous blood sampling for PRP preparation\n* Previous enrolment in the RELIEVE study","FEMALE","18 Years",{"count":91,"type":92},160,"ESTIMATED","INTERVENTIONAL",[95],"NA","Perineal tears and episiotomies are common after vaginal birth and may cause persistent pain, impaired wound healing, pain during sexual activity, and concerns about genital appearance.\n\nPlatelet-rich plasma (PRP) is prepared from a participant's own blood and contains a concentrated amount of platelets that release growth factors that may support tissue repair. The purpose of this study is to determine whether a single local injection of autologous non-activated PRP during the primary repair of a perineal tear and\u002For an episiotomy reduces postpartum perineal pain compared with an injection of 0.9% sodium chloride solution.\n\nParticipants will be randomly assigned in a 1:1 ratio to receive PRP or saline. Participants, the clinician administering the injection, the clinicians assessing the outcomes, and the statistician will be unaware of the assigned treatment. Follow-up will assess perineal pain, wound healing, scar quality, sexual function, genital self-image, and safety through 6 months postpartum.\n\nThe study hypothesis is that PRP will reduce average perineal pain at 3 months postpartum compared with saline.",[98,99,100,101],"Perineal Trauma","Postpartum Pain","Episiotomy","Perineal Laceration",[103,29,104,105,106,107,108,109,110,111],"Platelet-rich plasma","Vaginal birth","Perineal tear","Perineal wound healing","Postpartum perineal pain","Dyspareunia","Sexual function","Genital self-image","Scar assessment","NOT_YET_RECRUITING","2026-07-24",{"date":115,"type":116},"2026-07-27","ACTUAL",{"date":118,"type":92},"2026-10-01",{"date":120,"type":92},"2028-08-31",{"name":5,"class":6},1]