[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perineal-laceration-tear-or-rupture-during-delivery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perineal-laceration-tear-or-rupture-during-delivery":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100606012","physiotherapeutic-protocol-compared-to-usual-care-in-the-treatment-of-primiparas-after-perineal-trauma-100606012",false,"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.","FEMALE","18 Years",{"count":20,"type":21},82,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32,33,34],"Episiotomy","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",[36,37,38,39,40,41],"pelvic floor dysfunction","woman's health","perineal pain","vaginal birth","perineal tear","postpartum","RECRUITING","2025-11-24",{"date":45,"type":46},"2025-11-26","ACTUAL",{"date":48,"type":46},"2025-11-11",{"date":50,"type":21},"2029-03-20",{"name":52,"class":53},"University of Sao Paulo","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100587996","the-effect-of-birth-ball-and-perineal-massage-on-perineal-pain-perineal-trauma-and-birth-satisfaction-100587996","NCT06935643","The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfaction","The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfaction During the Intrapartum Period","Inclusion Criteria:\n\n* Between 18-35 years old\n* Active phase\n* Multipar\n* Singleton pregnancy\n* No risky pregnancy\n* No complications for vaginal delivery\n* Gestational week between 37-42\n* The amniotic membrane has not opened\n* No perineal scar tissue\n* The anterior cephalic position of the fetal head\n* Can speak and understand Turkish\n* Pregnant women who agreed to participate in the study\n\nExclusion Criteria:\n\n* Macrosomic fetus (birth weight over 4000 grams according to ultrasound calculation)\n* Vaginal infection and\u002For sexually transmitted disease\n\nResearch Termination Criteria\n\n* Cesarean section decision following trauma (due to fetal distress etc.)\n* Pregnant women who develop complications during labor (instrumental delivery, etc.)\n* Pregnant women who wish to withdraw from work",true,"35 Years",{"count":65,"type":21},144,[24],"One of the important causes of perineal trauma is perineal tension. By reducing this tension, perineal trauma can be prevented. Perineal trauma is a birth complication that can be prevented with midwifery approaches. The aim of this study was to investigate the effect of birth ball and perineal massage on perineal pain, perineal trauma and labor satisfaction in the intrapartum period.",[32,69,31],"Birth Satisfaction",[69,71,72,73,74],"Perineal trauma","Birth Ball","The Effect of perineal massage","The Effect of birth ball","NOT_YET_RECRUITING","2025-04-20",{"date":78,"type":46},"2025-04-24",{"date":80,"type":21},"2025-05-01",{"date":82,"type":21},"2025-10-01",{"name":84,"class":53},"Istanbul University - Cerrahpasa"]