[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643966":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":71,"collaborators":46,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":46,"enrollmentInfo":86,"targetDuration":46,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":104,"whyStopped":46,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Saint Andrew Hospital Constanta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PRP","EXPERIMENTAL","Participants receive a single local injection of autologous platelet-rich plasma (PRP) at the episiotomy wound site, administered intraoperatively or immediately postpartum, in addition to standard postpartum wound care.",[13],"Biological: Autologous Platelet-Rich Plasma (PRP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","ACTIVE_COMPARATOR","Routine postpartum care of the episiotomy wound according to the institution's standard protocol (local hygiene, standard analgesia), without any additional biological intervention.",[19],"Procedure: Standard Wound Care",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Autologous Platelet-Rich Plasma (PRP)","PRP is prepared from autologous peripheral venous blood collected from the participant at the time of delivery, processed by centrifugation to yield a platelet concentration above baseline whole-blood levels. The resulting PRP is administered as a single local injection into the tissue at the margins and base of the episiotomy wound, performed intraoperatively or immediately postpartum, before or shortly after suture closure. No additional PRP doses are administered after this single application, and no exogenous activating agents are used.",[9],[9,27],"Autologous Platelet Concentrate",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","Standard Wound Care","Participants in this arm receive routine postpartum care of the episiotomy wound, consisting of local hygiene measures (perineal cleansing, sitz baths as per institutional practice) and standard analgesia for postpartum perineal pain, without any additional biological, pharmacological, or procedural intervention targeting wound healing. No PRP, growth factor concentrate, topical wound-healing agent, or other regenerative product is applied.",[15],[34,35],"Standard Postpartum Wound Care","Routine Episiotomy Care",[37],{"name":38,"affiliation":39,"role":40},"Vlad Tica, Professor","Ovidius University","STUDY_DIRECTOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Dragos Brezeanu, Doctor","CONTACT","+40756508303",null,"brezeanudragos@gmail.com",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":46},"Ana Brezeanu, Doctor","+40727604808",[52],{"facility":53,"status":46,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Saint Andrew Hospital","Constanța","Constanța County","900184","Romania","RO",{"type":60,"coordinates":61},"Point",[62,63],28.63432,44.18073,{"lat":63,"lon":62},[66,69],{"name":38,"role":44,"phone":67,"phoneExt":46,"email":68},"+40721334543","vtica@eeirh.org",{"name":70,"role":44,"phone":46,"phoneExt":46,"email":46},"Viorel Cristurean, Professor",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"PRINCIPAL_INVESTIGATOR","Brezeanu Dragos","Principal Investigator","100643966","platelet-rich-plasma-versus-standard-care-for-episiotomy-wound-healing-in-postpartum-women-100643966",false,"NCT07669285","Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women","Efficacy of Autologous Platelet-Rich Plasma in Enhancing Episiotomy Wound Healing and Reducing Postpartum Perineal Pain: A Prospective Randomized Controlled Trial (PRP-EpiHeal)","PRP-EpiHeal","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Singular pregnancy, at term (≥ 37 weeks of gestation)\n* Vaginal delivery with episiotomy (midline or mediolateral)\n* Signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* Known coagulation disorders or thrombocytopenia (\\\u003C 100,000\u002Fmm³)\n* Severe anemia (hemoglobin \\\u003C 7 g\u002FdL) at the time of delivery\n* Active systemic or local perineal infection at the time of delivery\n* Uncontrolled diabetes mellitus or other significant comorbidities affecting wound healing (e.g., autoimmune disease under immunosuppressive treatment) Third- or fourth-degree perineal laceration (extending to the anal sphincter or rectal mucosa) Refusal to participate or inability to provide informed consent",true,"FEMALE","18 Years",{"count":87,"type":88},200,"ESTIMATED","INTERVENTIONAL",[91],"NA","This study looks at whether a treatment made from a patient's own blood, called platelet-rich plasma (PRP), can help heal the cut made during childbirth (episiotomy) better than standard care alone.\n\nPRP is prepared by drawing a small blood sample from the patient and spinning it in a centrifuge to concentrate the platelets, which contain natural healing factors. In this study, women who have an episiotomy during vaginal delivery will be randomly assigned to one of two groups: one group will receive a single injection of their own PRP at the wound site right after delivery, and the other group will receive the usual standard wound care. Neither group's care will otherwise differ.\n\nResearchers will follow each woman for 6 weeks after delivery, checking how well the wound is healing using a standard scoring tool (REEDA score), along with pain levels, any complications like infection or wound reopening, and how satisfied participants are with their recovery.\n\nThe goal is to find out whether this simple, low-risk treatment using a woman's own blood can speed up healing and reduce discomfort after childbirth.",[94,95,96,97],"Episiotomy","Platelet Rich Plasma (PRP)","Wound Healing","Obstetric",[99,100,101,102,103],"episiotomy","platelet rich plasma","wound healing","obstetric","postpartum period","NOT_YET_RECRUITING","2026-06-25",{"date":107,"type":108},"2026-06-30","ACTUAL",{"date":110,"type":88},"2026-06-21",{"date":112,"type":88},"2028-12-30",{"name":5,"class":6},1]