[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"obstetric-anal-sphincter-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:obstetric-anal-sphincter-injury":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,74,111,134,170],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100643892","postpartum-health-trajectories-the-first-year-after-obstetric-anal-sphincter-injury-and-the-impact-of-a-group-based-intervention-100643892",false,"NCT07667660","Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention","Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention: The ADAPT Randomized Controlled Trial","ADAPT","Inclusion Criteria:\n\n* Obstetric Anal Sphincter Injury (OASI - Grade 3-4 tear) and clinical follow-up postpartum at the \"Pelvic Clinic\" at Herlev Hospital\n* 18 years of age or above and the capacity to provide informed consent\n* Fluent in Danish language\n\nExclusion Criteria:\n\n* Referred patients from other hospitals due to complicated healing\n* Patients where other Hospitals are responsible for the clinical follow-up","FEMALE","18 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of the ADAPT study is to investigate whether a structured, group-based follow-up programme can improve quality of life related to anal incontinence in women with OASI during the first year after childbirth. The study will also describe how symptoms change over time and assess effects on mental health, sexual function, symptoms of prolapse and urinary incontinence, and body image.",[27],"Obstetric Anal Sphincter Injury",[29,30,31,32],"obstetric tear","women's health","anal incontinence","obstetric anal sphincter injury","NOT_YET_RECRUITING","2026-06-18",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":21},"2026-08-01",{"date":41,"type":21},"2029-08-31",{"name":43,"class":44},"Hanna Jangö","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100643236","papaverine-for-prevention-of-perineal-trauma-100643236","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","45 Years",{"count":55,"type":21},412,[24],"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.",[59,27],"Perineal Trauma",[61,59,62,63],"Papaverine","Labor","Vaginal Delivery","2026-06-06",{"date":66,"type":37},"2026-06-11",{"date":68,"type":21},"2026-06-03",{"date":70,"type":21},"2027-06-03",{"name":72,"class":73},"Dr Raneen Abu Shqara","OTHER_GOV",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":94,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":45},"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":83,"type":21},82,[24],"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.",[87,88,27,89,90,91,92,93],"Episiotomy","Lacerations Perineal","Perineal Injury","Perineal Laceration, Tear, or Rupture During Delivery","Perineal Pain","Perineal Tear Resulting From Childbirth","Perineal Tear and Episiotomy",[95,96,97,98,99,100],"pelvic floor dysfunction","woman's health","perineal pain","vaginal birth","perineal tear","postpartum","RECRUITING","2025-11-24",{"date":104,"type":37},"2025-11-26",{"date":106,"type":37},"2025-11-11",{"date":108,"type":21},"2029-03-20",{"name":110,"class":44},"University of Sao Paulo",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":45},"100597764","pelvic-floor-exercises-for-suboptimal-anorectal-manometry-100597764","NCT07062731","Pelvic Floor Exercises for Suboptimal Anorectal Manometry","Effect of Pelvic Floor Muscle Exercises on Women With Suboptimal Anorectal Manometry Results After an Obstetric Anal Sphincter Injury (OASI)","Inclusion Criteria:\n\n1. Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:\n\n   1. Are at least 6 weeks postpartum\n   2. Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist postpartum\n2. Either able to speak, read and write in English, or has a professional interpreter present at the time of appointment.\n3. Capable of understanding and signing the informed consent form after full discussion of the investigations and its risks and benefits.\n4. Able and willing to complete the St Mark's Score, ICIQ-UI SF and other trial related questionnaires, comply with scheduled clinic visits and manometry studies.\n\nExclusion Criteria:\n\n* Inclusion Criteria\n\n  1. Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:\n\n     1. Are at least 6 weeks postpartum\n     2. Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist postpartum\n  2. Either able to speak, read and write in English, or has a professional interpreter present at the time of appointment.\n  3. Capable of understanding and signing the informed consent form after full discussion of the investigations and its risks and benefits.\n  4. Able and willing to complete the St Mark's Score, ICIQ-UI SF and other trial related questionnaires, comply with scheduled clinic visits and manometry studies.\n\nExclusion Criteria\n\n1. Women who have sustained an obstetric anal sphincter injury more than a year ago\n2. Women who have had another vaginal delivery after sustaining an obstetric anal sphincter injury in a previous delivery.\n3. Existing anal pain precluding anorectal examination\n4. Existing neurological, musculoskeletal disorders which impedes ability to perform pelvic floor muscle exercises\n5. Age \\\u003C18 years old\n6. Currently pregnant\n7. Inability to comply with pelvic floor muscle exercises",{"count":119,"type":21},50,"OBSERVATIONAL","Currently, guidelines from the Royal College of Obstetricians and Gynaecologists stipulate that all women who have sustained an obstetric anal sphincter injury in a previous pregnancy and who are symptomatic or have abnormal endoanal ultrasonography and\u002F or manometry should be counselled regarding the option of an elective Caesarean section. An abnormal endoanal ultrasonography is currently considered to be a defect of the external anal sphincter (EAS) of more than 30 degrees while an abnormal anorectal manometry would be an incremental squeeze pressure of less than 20mmHg.\n\nThis study aims to evaluate if a course of guided pelvic floor exercises could improve anal sphincter function on those with suboptimal or abnormal anal incremental squeeze pressures, and subsequently expand their options for future modes of delivery (vaginal delivery not contraindicated)",[27],[124],"pelvic floor muscle exercises","2025-07-03",{"date":127,"type":37},"2025-07-14",{"date":129,"type":37},"2025-06-15",{"date":131,"type":21},"2027-09-15",{"name":133,"class":44},"King's College Hospital NHS Trust",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":17,"minAge":18,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":45},"100527077","care-for-oasi-study-care-pathways-and-anorectal-evaluation-for-oasi-associated-incontinence-100527077","NCT06143072","CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence","Referral Pathways and Care Provision for Patients Who Develop OASI Associated Incontinence in the First Five Years Following a Vaginal Delivery","CArE for OAsI","Part 1 of Study\n\nInclusion Criteria:\n\n* • Fertile women ≥ 18 years and ≤50 who have developed OASI related incontinence following a vaginal delivery in the preceding five years (N.B. the average age of menopause in the UK is 51)\n\n  * Tertiary referrals to the specialist perineal clinic as well as patients who have 'slipped' through the existing pathway of referral\n  * Capacity to consent (able to comprehend and retain information, weight out the risks and benefits and communicate a decision back to the researcher)\n  * English-speaking and able to comprehend and read English\n  * Primiparous\u002Fmulti-parous\n\nExclusion Criteria:\n\n* • Women who are unable to consent or who have severe mental illness, as decided by the screening clinician\n\n  * Patients who do not speak, read or understand English\n  * Patients with an alternative documented cause for their FI that is non obstetric trauma related.\n  * Post-menopausal women who may develop late onset symptoms of incontinence relating to a previous OASI (clinically silent injuries that manifest in later life secondary to hormonal influences or advancing age for example).\n  * Women with an OASI who have been referred directly from the maternity unit at the same trust as the specialist perineal clinic, where an existing trust policy exists for direct referral of these patients from the maternity unit to the perineal clinic.\n\nPart 2 of study:\n\nInclusion criteria:\n\n• urogynaecologists\u002Fobstetricians who oversee the care of or look after patients with OASI and who are practising in UK NHS hospitals at the time of completion of the survey. They must be on the GMC specialist register to be eligible to participate\n\nExclusion criteria:\n\n• trainees, obstetricians\u002Fgynaecologists not routinely involved in the care of OASI patients.",true,"50 Years",{"count":145,"type":21},112,"The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be safeguarded by the presence of robust care pathways that ensure adequate follow up and care provision.\n\nAs obstetric anal sphincter injuries have been associated with increased litigation rates over the years, positive interventions towards patient care will help ameliorate the financial burden that litigation carries on the National Health Service. It is noteworthy of mention that perineal injury, in itself, may not be suggestive of negligent care and is a recognized complication of vaginal delivery. However, a failure to adequately manage the injury may carry medicolegal implications.",[27,148,149,150,151,152,153,154,155,156,157,158,159,160],"Severe Perineal Trauma","Grade 3 Perineal Tear","Grade 4 Perineal Tear","Anal Incontinence","Faecal Incontinence","Urgency","Deferral Time","Pathways","Follow-up","Review","Endo-anal Ultrasound","Urogynaecology","Biofeedback","2025-05-21",{"date":163,"type":37},"2025-05-25",{"date":165,"type":37},"2024-01-01",{"date":167,"type":21},"2025-07-01",{"name":169,"class":44},"London North West Healthcare NHS Trust",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":45},"100575533","use-of-three-dimensional-transvaginal-ultrasound-for-anal-sphincter-evaluation-100575533","NCT06773520","Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation","Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation: \"A New Technique\"","3D_TV_OASIS","Inclusion Criteria:\n\n* Pregnant nulliparous or primiparous women;\n* Age between 18 and 44 years\n* Acquisition of informed consent form\n\nExclusion Criteria:\n\nNone","44 Years",{"count":180,"type":21},200,"The goal of this observational study is to evaluate the reproducibility of new 3D\u002F4D ultrasound volume analysis techniques in the assessment of anal sphincter integrity and thickness in both pregnancy and immediate postpartum.\n\nThe negative impact that OASISs (Obstetric Anal Sphincter Injuries), and possible subsequent anal incontinence, have on women's quality of life has stimulated research in this field in recent decades. However, there are still few studies concerning the topic. The transperineal approach by means of the transvaginal probe in the study of the pelvic floor, anal sphincter and related lesions has helped us to make strides in our knowledge of the anatomy of the pelvic floor and in defining the lesions that may affect it.",[27],[184],"3D untrasound","2025-01-13",{"date":187,"type":37},"2025-01-14",{"date":189,"type":37},"2023-11-21",{"date":191,"type":21},"2027-08-31",{"name":193,"class":44},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]