Obstetric Anal Sphincter Injury

6

Review clinical trials related to Obstetric Anal Sphincter Injury. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention

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.

Participants needed: 110
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Hanna JangöUpdated: Jun 25, 2026Locations: 1
Eligibility criteria

Obstetric Anal Sphincter Injury (OASI - Grade 3-4 tear) and clinical follow-up p... [+2]

Referred patients from other hospitals due to complicated healing [+1]

Status: Not yet recruiting

Papaverine for Prevention of Perineal Trauma

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. This 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.

Participants needed: 412
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Dr Raneen Abu ShqaraUpdated: Jun 11, 2026
Eligibility criteria

Primiparous patients aged 18 years or older [+5]

Multiple gestation [+9]

Status: Recruiting

Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma

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.

Participants needed: 82
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of Sao PauloUpdated: Nov 26, 2025Locations: 1
Eligibility criteria

The study will include female at birth aged 18 years or older, primiparous (no p...

Women with conditions such as severe pre-eclampsia or infections, sick newborns...

Status: Recruiting

Pelvic Floor Exercises for Suboptimal Anorectal Manometry

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/ 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. This 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)

Participants needed: 50
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: King's College Hospital NHS TrustUpdated: Jul 14, 2025Locations: 1
Eligibility criteria

Are at least 6 weeks postpartum [+4]

Inclusion Criteria [+12]

Status: Recruiting

CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence

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. As 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.

Participants needed: 112
Trial details
Age: 18-50Biological sex: FemaleType: ObservationalSponsor: London North West Healthcare NHS TrustUpdated: May 25, 2025Locations: 1
Eligibility criteria

• Fertile women ≥ 18 years and ≤50 who have developed OASI related incontinence... [+4]

• Women who are unable to consent or who have severe mental illness, as decided... [+4]

Status: Recruiting

Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation

The goal of this observational study is to evaluate the reproducibility of new 3D/4D ultrasound volume analysis techniques in the assessment of anal sphincter integrity and thickness in both pregnancy and immediate postpartum. The 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.

Participants needed: 200
Trial details
Age: 18-44Biological sex: FemaleType: ObservationalSponsor: IRCCS Azienda Ospedaliero-Universitaria di BolognaUpdated: Jan 14, 2025Locations: 1
Eligibility criteria

Pregnant nulliparous or primiparous women; [+2]