[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perineal-trauma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perineal-trauma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100643236","papaverine-for-prevention-of-perineal-trauma-100643236",false,"NCT07641543","Papaverine for Prevention of Perineal Trauma","The Impact of Intrapartum Papaverine 80 mg on Perineal Trauma Among Primiparous Women: a Prospective Randomized Double-blind Study.","Inclusion Criteria:\n\n* Primiparous patients aged 18 years or older\n* Singleton pregnancy\n* Term pregnancy (37+0 to 42+0 weeks of gestation)\n* Cephalic presentation\n* Undergoing labor with at least with 2 cm cervical dilatation.\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Multiple gestation\n* Major fetal congenital anomalies\n* Contraindication to vaginal delivery\n* Known hypersensitivity or allergy to papaverine hydrochloride\n* Known supraventricular tachycardia (SVT)\n* Maternal tachycardia (heart rate \\>100 bpm) or clinically significant cardiac arrhythmia\n* Known liver disease or hepatic dysfunction\n* Active psychiatric condition impairing the ability to provide informed consent\n* Inability to provide written informed consent\n* Planned cesarean delivery","FEMALE","18 Years","45 Years",{"count":20,"type":21},412,"ESTIMATED","INTERVENTIONAL",[24],"NA","Perineal trauma is a common complication of vaginal delivery, particularly among primiparous patients, and may result in short- and long-term maternal morbidity, including pain, dyspareunia, and pelvic floor dysfunction. Papaverine hydrochloride, a smooth muscle relaxant with vasodilatory properties, has been shown to improve tissue relaxation and has been used safely in obstetric settings.\n\nThis prospective randomized double-blind placebo-controlled study aims to evaluate whether intrapartum intravenous papaverine hydrochloride (80 mg), administered at full cervical dilatation, reduces the rate of perineal trauma among primiparous patients undergoing vaginal delivery. Eligible participants will be randomized in a 1:1 ratio to receive either intravenous papaverine hydrochloride or placebo (normal saline). Maternal, obstetric, and neonatal outcomes, including the rate and severity of perineal trauma, obstetric anal sphincter injuries (OASIS), postpartum hemorrhage, and neonatal outcomes, will be assessed.",[27,28],"Perineal Trauma","Obstetric Anal Sphincter Injury",[30,27,31,32],"Papaverine","Labor","Vaginal Delivery","NOT_YET_RECRUITING","2026-06-06",{"date":36,"type":37},"2026-06-11","ACTUAL",{"date":39,"type":21},"2026-06-03",{"date":41,"type":21},"2027-06-03",{"name":43,"class":44},"Dr Raneen Abu Shqara","OTHER_GOV",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100630843","hands-on-vs-hands-off-techniques-in-perineal-protection-100630843","NCT07492940","Hands-on vs Hands-off Techniques in Perineal Protection","The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.","MPP","Criteri di inclusione:\n\n* Donne incinte nullipare o multipare\n* Gravidanza a termine\n* Feto nella presentazione cefalica\n* Consegna eutocic (spontanea)\n* Uso di ossitocina\n* Uso di analgesici\n\nCriteri di esclusione:\n\n* Parto prematuro: prematuro tardivo -Disagio fetale acuto durante la fase di espulsione-\n* Consegna della gretta\n* Distocia della spalla\n* Parto chirurgico (uso del vuoto ostetrico, manovra di Kristeller, taglio cesareo) --Episiotomia",{"count":54,"type":21},737,"OBSERVATIONAL","Perineal tears are frequent during vaginal delivery. This study evaluates the impact of hands-on versus hands-off techniques on perineal and neonatal outcomes to determine the most effective protective strategy.",[27,58,59,60],"Hands-on Technique","Hands-of Technique","Manual Perineal Protection",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"Perineal trauma","Perineal injury","Perineal lacerations","Perineal tears","Obstetric anal sphincter injuries","OASIS","Genital tract trauma","Labial lacerations","Labial tears","Vaginal tears","Pelvic floor muscle injury","Levator ani muscle avulsion","First-degree perineal tear","Second-degree perineal tear","Third-degree perineal tear","Fourth-degree perineal tear","hands on","hands off","hands-on technique","hands-off technique","RECRUITING","2026-03-20",{"date":85,"type":37},"2026-03-25",{"date":87,"type":21},"2026-03-05",{"date":89,"type":21},"2027-03",{"name":91,"class":92},"Azienda ULSS 8 Berica","OTHER",1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":101,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":103,"conditions":104,"keywords":110,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100629706","maternal-musculoskeletal-factors-of-the-hip-lumbopelvic-abdominal-and-pelvic-floor-regions-and-their-association-with-mode-of-delivery-and-postpartum-pelvic-floor-dysfunction-100629706","NCT07478159","Maternal Musculoskeletal Factors of the Hip, Lumbopelvic, Abdominal and Pelvic Floor Regions and Their Association With Mode of Delivery and Postpartum Pelvic Floor Dysfunction","Inclusion Criteria:\n\n* Pregnant women aged 18 years or older\n* Singleton pregnancy\n* Gestational age of 36 weeks at the time of the baseline assessment\n* Receiving prenatal care in primary healthcare centers of Zaragoza (Spain)\n* Ability to understand study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* High-risk pregnancy conditions that may affect labor progression or maternal musculoskeletal assessment (e.g., severe obstetric complications requiring planned cesarean section)\n* Previous pelvic floor surgery\n* Neurological or musculoskeletal disorders affecting the lumbopelvic or pelvic floor region\n* Inability to complete the assessment protocol or questionnaires",true,{"count":102,"type":21},376,"This prospective observational cohort study aims to investigate the association between maternal musculoskeletal factors of the hip, lumbopelvic, abdominal, and pelvic floor regions and childbirth outcomes, as well as their consequences on pelvic floor function during the postpartum period. A total of 376 pregnant women will be recruited at 36 weeks of gestation and followed until 12 weeks postpartum. Musculoskeletal assessments will include hip range of motion, lumbopelvic mobility, abdominal muscle function, and pelvic floor strength and morphology. Obstetric outcomes such as mode of delivery and perineal trauma will be recorded after childbirth. The study will analyze whether maternal musculoskeletal function during late pregnancy is associated with delivery mode and pelvic floor dysfunction in the postpartum period.",[105,106,27,107,108,109],"Pelvic Floor Disorders","Urinary Incontinence","Pelvic Floor Dysfunction","Pregnancy","Puerperium",[105,111,112,106],"Obstetric Labor","Complications Perineal Trauma","2026-03-12",{"date":115,"type":37},"2026-03-17",{"date":117,"type":21},"2026-05-01",{"date":119,"type":21},"2028-01-01",{"name":121,"class":92},"Universitat Internacional de Catalunya"]