[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"episiotomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:episiotomy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,51,79,116,141,177,202],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"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":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Episiotomy","Platelet Rich Plasma (PRP)","Wound Healing","Obstetric",[33,34,35,36,37],"episiotomy","platelet rich plasma","wound healing","obstetric","postpartum period","NOT_YET_RECRUITING","2026-06-25",{"date":41,"type":42},"2026-06-30","ACTUAL",{"date":44,"type":22},"2026-06-21",{"date":46,"type":22},"2028-12-30",{"name":48,"class":49},"Saint Andrew Hospital Constanta","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100633746","video-supported-flipped-learning-for-episiotomy-training-in-midwifery-students-100633746","NCT07530692","Video-Supported Flipped Learning for Episiotomy Training in Midwifery Students","The Effect of Video-Supported Flipped Learning Model in Episiotomy Education on Anxiety and Skill Levels of Midwifery Students","Inclusion Criteria:\n\n* Midwifery 3rd-year student who is taking the Normal Birth course\n* Willing to participate and provides informed consent\n* Has not received prior education in the health field during associate or undergraduate education\n* Has access to the internet and has a computer and\u002For smartphone\n\nExclusion Criteria:\n\n* Incomplete completion of data collection forms\n* Has received prior education in the health field during associate or undergraduate education\n* No access to the internet, computer, or smartphone\n* Does not participate in the study procedures\u002Fintervention sessions\n* Requests to withdraw from the study at any time",{"count":59,"type":22},60,[25],"This study aims to evaluate the effect of a video-supported flipped learning model on anxiety and skill levels of midwifery students in episiotomy education. Episiotomy is an important clinical skill in midwifery education, and the method used to teach this skill may influence students' anxiety and performance.\n\nThis randomized controlled educational study will be conducted with midwifery students who are enrolled in the episiotomy course. Participants will be randomly assigned to either an intervention group or a control group. Students in the intervention group will receive episiotomy education using a video-supported flipped learning model, in which theoretical content is provided through instructional videos prior to in-class activities. The control group will receive traditional classroom-based education.\n\nStudents' anxiety levels and episiotomy skill performance will be assessed using validated measurement tools before and after the educational intervention. The findings of this study are expected to contribute to evidence-based teaching strategies in midwifery education and support the use of innovative learning models to improve student outcomes.",[63,28,64,65],"Anxiety","Midwifery","Clinical Competence",[28,67,68,69,70],"Video-Based Learning","Midwifery Students","Simulation Training","Randomized Controlled Trial","2026-04-08",{"date":73,"type":42},"2026-04-15",{"date":73,"type":22},{"date":76,"type":22},"2026-07-20",{"name":78,"class":49},"Karabuk University",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":102,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":50},"100632191","effects-of-breastfeeding-virtual-reality-and-stress-ball-on-pain-anxiety-cortisol-levels-and-comfort-during-episiotomy-repair-100632191","NCT07510477","Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair","Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair in Primiparous Women: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Pregnant women between 18 and 45 years of age.\n* Primiparous women (first-time mothers).\n* Gestational age between 37 and 42 weeks (term pregnancy).\n* Singleton pregnancy with a vertex presentation.\n* Spontaneous vaginal delivery requiring a mediolateral episiotomy.\n* Newborn birth weight between 2500 and 4500 grams.\n* Newborn Apgar scores of 7 or higher at the 1st and 5th minutes.\n* Ability to read, understand, and speak Turkish fluently.\n* Voluntary participation with signed informed consent.\n\nExclusion and Withdrawal Criteria:\n\n* Requesting to withdraw from the research at any stage.\n* Presence of any congenital anomalies in the newborn.\n* Presence of maternal visual or hearing impairments.\n* Occurrence of fetal mortality or morbidity.\n* Occurrence of anal sphincter injury or 3rd\u002F4th-degree lacerations in addition to the episiotomy.\n* Performance of the episiotomy repair in an operating room.\n* Use of assisted delivery methods (e.g., vacuum extraction).\n* Administration of sedative drugs or extra anesthetic agents (excluding routine local perineal infiltration).\n* Development of maternal complications (e.g., postpartum hemorrhage) preventing data collection.","45 Years",{"count":88,"type":22},120,[25],"The goal of this clinical trial is to learn about the effects of three different interventions-breastfeeding, using a stress ball, or wearing virtual reality (VR) goggles-on pain, anxiety, and stress during episiotomy repair (stitching) after childbirth. It also aims to examine how these methods affect a mother's comfort after the procedure.\n\nThe main questions it aims to answer are:\n\nDoes breastfeeding, using a stress ball, or using VR goggles lower the mother's pain and anxiety during the repair? Do these interventions reduce the mother's biological stress levels, measured by saliva cortisol tests? Do these methods lead to higher postpartum comfort levels for the mother in the first 24 hours after birth?\n\nResearcher will compare these three intervention groups to a \"control group\" (mothers receiving standard hospital care) to see which approach is most effective.\n\nParticipants will:\n\nBe randomly assigned to one of four groups: Breastfeeding, VR Goggles, Stress Ball, or Standard Care.\n\nUse their assigned intervention throughout the entire episiotomy repair process.\n\nProvide saliva samples before and after the procedure to measure stress hormones (cortisol).\n\nRate their pain and anxiety levels using clinical scales twice: once before the procedure begins and once immediately after it is finished.\n\nComplete a survey about their comfort levels between 6 and 24 hours after the delivery.",[28,92,93,94,63,95,96,97,98,99,100,101,64],"Breastfeeding","Virtual Reality","Virtual Goggles","Cortisol","Postpartum Comfort","Postpartum Comfort Scale","Stress Physiological","PAIN, ANXIETY, AND COMFORT","Acute Pain","Stress Ball",[92,93,101,103,104,70,105,28,106],"Midwifery Care","Primiparous Women","Salivary Cortisol","Episiotomy Repair","2026-03-30",{"date":109,"type":42},"2026-04-03",{"date":111,"type":22},"2026-04",{"date":113,"type":22},"2027-09",{"name":115,"class":49},"Aydin Adnan Menderes University",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":139,"locationsCount":50},"100622438","the-effect-of-stapler-versus-skin-suturing-on-pain-and-wound-healing-after-episiotomy-repair-in-primiparous-women-100622438","NCT07383623","THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN","THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN: A RANDOMIZED CONTROLLED TRIAL","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Term pregnancy (≥ 37 weeks)\n* Low-risk pregnancy (no obstetric risk factors)\n* Not receiving oxytocin induction during latent or active labor\n* Singleton pregnancy with a live fetus\n* No psychiatric disorder\n* No substance abuse\n* Primiparous women (first vaginal birth)\n* Presence of 1st or 2nd degree perineal tear\n* Able to read, understand, and voluntarily provide written and verbal informed consent.\n\nExclusion Criteria:\n\n* Apgar score \\\u003C 7 at 1 minute and\u002For 5 minutes\n* Neonatal anomaly\n* Use of \\>10 mL analgesic during episiotomy repair beyond routine practice\n* Obesity\n* Vaginal infection or vaginal lesion\n* Maternal conditions impairing wound healing (e.g., diabetes mellitus, immunosuppression, coagulation disorders)\n* 3rd or 4th degree perineal tear\n* Shoulder dystocia \u002F difficult delivery","49 Years",{"count":125,"type":22},24,[25],"This randomized controlled study aims to evaluate the effects of skin closure using surgical staplers compared with conventional skin sutures on postoperative pain and wound healing in primiparous women undergoing episiotomy repair after vaginal delivery.\n\nPrimiparous women who require episiotomy during vaginal birth will be randomly assigned to one of two groups: skin closure with staples or skin closure with sutures. Postpartum pain levels and wound healing outcomes will be assessed and compared between the two groups.\n\nThe results of this study are expected to contribute to evidence-based decisions regarding optimal skin closure techniques in episiotomy repair.",[28],[33,130,131],"stapler","primiparous women","RECRUITING","2026-02-06",{"date":135,"type":42},"2026-02-10",{"date":137,"type":42},"2025-10-01",{"date":41,"type":22},{"name":140,"class":49},"Ayşegül Kanık",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":152,"conditions":153,"keywords":161,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":50},"100606012","physiotherapeutic-protocol-compared-to-usual-care-in-the-treatment-of-primiparas-after-perineal-trauma-100606012","NCT07170007","Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma","Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Postpartum Primiparas After Perineal Trauma: A Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial With Economic Evaluation","MPR","Inclusion Criteria:\n\n* The study will include female at birth aged 18 years or older, primiparous (no previous pregnancy after 16 weeks), who have suffered a perineal laceration of grade ≥2 or episiotomy, with ≥37 weeks of gestation at the time of delivery, who have not used testosterone in the last 6 months, with preserved cognitive ability, no history of neurological diseases, no symptoms of vaginal or urinary tract infection and no perineal diseases such as fistulas, genital mutilation, previous perineal surgery for pelvic floor dysfunction or Crohn's disease. According to the Robson 10-Group Classification System, only women belonging to group 1 (nulliparous women with a single vital cephalic pregnancy, ≥37 weeks of gestation in spontaneous labor) and group 2a (nulliparous women with a single vital cephalic pregnancy, ≥37 weeks of gestation who had labor induced) will be included in the study.\n\nExclusion Criteria:\n\n* Women with conditions such as severe pre-eclampsia or infections, sick newborns or women who refuse to take part in the study will not be included. Participation is voluntary and participants can withdraw from the study at any time.",{"count":150,"type":22},82,[25],"The aim of this study is to assess the effectiveness of a pelvic floor muscle training (PFMT) protocol associated with cryotherapy initiated in the immediate postpartum period in relieving pain in primiparous women who suffered perineal trauma during vaginal delivery. This is a hybrid effectiveness-implementation type 1 randomized controlled trial with economic evaluation, which will include 82 primiparous women who suffered a perineal tear of grade 2 or above or episiotomy during vaginal delivery. The study participants will be selected from among the women who gave birth at the Hospital das Clínicas in Ribeirão Preto and will be randomly assigned to participate in one of two study groups: the Control Group will receive the usual maternity care, that includes suturing the injury and analgesic medication, and the Intervention Group will receive the usual care combined with a physiotherapy protocol of PFMT and cryotherapy, starting in the immediate postpartum period and lasting 3 months. The primary outcome of the study will be the change in perineal pain intensity assessed using an 11-point Numerical Rating Scale; and the secondary outcomes will be self-reported pelvic floor dysfunction, recovery from injury, functionality, health-related quality of life, use of pain medication, genital self-image and implementation outcomes (satisfaction, acceptability, adequacy, feasibility, equity and adherence to the protocol). Assessments will be carried out by a group of health professionals, including physiotherapists and physicians, at 11 points up to 6 months after delivery. Two doctors from the service will be responsible for carrying out the transperineal ultrasound examination to assess the injury, which will be sent to a third international collaborating physician (SD) to assess the results blindly. The other assessments will be carried out by two physiotherapists.Descriptive statistics will be used, including the ANOVA test to confirm homogeneity between the groups, the chi-square test or Fisher's test for categorical variables and Student's t-test or Wilcoxon's non-parametric test for independent samples for quantitative variables.",[28,154,155,156,157,158,159,160],"Lacerations Perineal","Obstetric Anal Sphincter Injury","Perineal Injury","Perineal Laceration, Tear, or Rupture During Delivery","Perineal Pain","Perineal Tear Resulting From Childbirth","Perineal Tear and Episiotomy",[162,163,164,165,166,167],"pelvic floor dysfunction","woman's health","perineal pain","vaginal birth","perineal tear","postpartum","2025-11-24",{"date":170,"type":42},"2025-11-26",{"date":172,"type":42},"2025-11-11",{"date":174,"type":22},"2029-03-20",{"name":176,"class":49},"University of Sao Paulo",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":184,"minAge":19,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100564183","evaluation-of-interventions-based-on-behavioral-sciences-to-reduce-episiotomy-use-100564183","NCT06625866","Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use","Design, Implementation, and Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use: a Pilot Study","Inclusion Criteria:\n\n* Healthcare personnel involved in decision-making associated with performing episiotomies who work in the hospital selected to pilot the proposed intervention.\n\nExclusion Criteria:\n\n* Healthcare personnel who are not involved in the decision-making process over performing episiotomy during delivery.","ALL",{"count":186,"type":22},2,[25],"This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.",[28,190,191,192],"Episiotomy Extended by Laceration","Episiotomy Infection","Episiotomy Wound","2024-10-01",{"date":195,"type":42},"2024-10-03",{"date":197,"type":22},"2024-10",{"date":199,"type":22},"2025-10",{"name":201,"class":49},"Universidad Panamericana",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":50},"100559757","lignocaine-vs-bupivacaine-infiltration-for-postpartum-perineal-pain-after-vaginal-delivery-with-episiotomy-in-primigravidae-100559757","NCT06568289","Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae","Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae: A Prospective Randomized, Double-Blind, Clinical Trial","Inclusion Criteria:\n\n* Primigravidae with the full term undergoing vaginal delivery with episiotomy.\n* Pregnancies and singleton vertex cephalic fetuses.\n* In the active phase of the first stage of labor.\n\nExclusion Criteria:\n\n* Patients with history of drug allergies to study drugs as this will increase the risk of complications.\n* Patients undergoing vaginal delivery under epidural or spinal anesthesia as they will affect post-operative pain and interfere with assessment of efficacy of local infiltration of the study drugs.\n* Evidence of local infection at site of injection as this will interfere with the action of the study drug and will increase the risk of complications.\n* Inability to cooperate as this will affect our assessment.\n* Patient's refusal.\n* Any intraoperative complications that will affect our outcome criteria (bleeding, organ injury) as they will affect patient's vital data and affect our assessment.\n* Neurological comorbidities (chronic pain disorder, chronic systemic disease, neurological disorder, neuropathic pain) as they will need more analgesia.\n* Drug abuse as they will be tolerant to the used analgesics.","40 Years",{"count":59,"type":22},[25],"In this study, we will compare the effect and safety of lignocaine versus bupivacaine infiltration for postpartum perineal pain after vaginal delivery with episiotomy in primigravidae.",[214,215,216,217,28,218],"Lignocaine","Bupivacaine","Postpartum Perineal Pain","Vaginal Delivery","Primigravidae","2024-08-22",{"date":221,"type":42},"2024-08-23",{"date":223,"type":42},"2024-03-01",{"date":225,"type":22},"2024-09-01",{"name":227,"class":49},"Ain Shams University"]