Clinical trials: Obstetric Anal Sphincter Injury
Anal Sphincter Injury, Obstetrics Trauma
External Phase MRI in Diagnosis of OASI
There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in Finland complicate in a Grade III- IV perineal tear.
- Trial name
- NCT03039374
- Testing
- Magnetic resonance imaging
- Volunteers
- 53 people
- Sponsor
- University of Turku
Perineal Trauma, Hands-on Technique
Hands-on vs Hands-off Techniques in Perineal Protection
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.
- Conditions
- Perineal Trauma, Hands-on Technique, Hands-of Technique, Manual Perineal Protection
- Trial name
- MPP (NCT07492940)
- Where
- Italy
- Volunteers
- 737 people
- Sponsor
- Azienda ULSS 8 Berica
Obstetric Trauma, Anal Sphincter Injury
Anal Incontinence After Obstetrical Anal Sphincter Injury
Obstetrical Anal Sphincter Injury is an identified risk factor for anal incontinence. The mechanisms and the risk factors for anal incontinence in Obstetrical Anal Sphincter Injury women are not well known.
- Conditions
- Obstetric Trauma, Anal Sphincter Injury, Anal Incontinence
- Trial name
- INCONT-LOSA (NCT04940494)
- Testing
- collection of data
- Where
- France
- Volunteers
- 227 people
- Sponsor
- University Hospital, Angers
Obstetric Anal Sphincter Injury, Episiotomy Wound
Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery
Literature is contradictory about the impact of mediolateral episiotomy during operative vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence of international guidelines.
- Conditions
- Obstetric Anal Sphincter Injury, Episiotomy Wound, Anal Incontinence, Pelvic Floor Disorders
- Trial name
- INSTRUMODA (NCT04446780)
- Testing
- Mediolateral episiotomy
- Where
- France
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Poitiers University Hospital
Obstetric Anal Sphincter Injury, Severe Perineal Trauma
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.
- Conditions
- Obstetric Anal Sphincter Injury, Severe Perineal Trauma, Grade 3 Perineal Tear, Grade 4 Perineal Tear
- Trial name
- CArE for OAsI (NCT06143072)
- Where
- United Kingdom
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- London North West Healthcare NHS Trust
Perineal Trauma, Pelvic Floor Dysfunction
Pelvic Floor Training Program and Perineal Trauma During Vaginal Birth
This study aims to determine whether a structured pelvic floor muscle training program during pregnancy can reduce perineal trauma during vaginal birth.
- Conditions
- Perineal Trauma, Pelvic Floor Dysfunction, Labor Complications, Pelvic Floor Muscle Training
- Trial name
- PFTP (NCT07292948)
- Testing
- Pelvic Floor Muscle Training Program
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Mehmet Incebıyik
Obstetric Anal Sphincter Injury, Delivery, Obstetric
Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective.
- Trial name
- NCT03769792
- Testing
- Blood and faeces tests, Impedance spectroscopy test, Full gynecological and proctological examination
- Where
- Poland
- Volunteers
- 20 people
- Sponsor
- OASIS Diagnostics S.A.
Obstetric Anal Sphincter Injury
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.
- Trial name
- 3D_TV_OASIS (NCT06773520)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Obstetric Anal Sphincter Injury, Vaginal Electrical Stimulation
Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery
For too many women, childbirth results in devastating consequences: involuntary loss of feces or urine (fecal or urinary incontinence).
- Trial name
- VESPR (NCT02701413)
- Testing
- ApexM (Stimulation) Device
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Northwestern University
Obstetric Anal Sphincter Injury
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…
- Trial name
- NCT07062731
- Testing
- Supervised pelvic floor muscle exercises
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- King's College Hospital NHS Trust
Obstetric Complication, Obstetric Trauma
Consequences of Obstetric Anal Sphincter Injuries on Maternal Psychology and Relationship Experience
The aim is to ascertain whether sustaining an Obstetric Anal Sphincter Injury negatively impacts intra-family relationships and increases the risk of mental health conditions, including a women's perception of herself and her…
- Conditions
- Obstetric Complication, Obstetric Trauma, Perineal Tear, Incontinence
- Trial name
- COMPaRE (NCT05935371)
- Where
- United Kingdom
- Volunteers
- 87 people
- Sponsor
- London North West Healthcare NHS Trust
Anal Sphincter Injury
The Effect of Episiotomy on Maternal and Fetal Outcomes (EPITRIAL)
This study is aimed to evaluate the influence of episiotomy on various maternal and neonatal outcomes. Half of the participants will undergo selective episiotomy (according to routine delivery management at the particular…
- Trial name
- NCT02356237
- Testing
- No episiotomy
- Where
- Israel
- Volunteers
- 676 people
- Sponsor
- Lena Sagi-Dain
Obstetric Anal Sphincter Injury
Primary Repair of Obstetric Anal Sphincter Injuries (OASIS) by Surgeons (PROS Study)
Third- or fourth-degree perineal tears, collectively known as Obstetric Anal Sphincter Injuries or OASIS, may occur following a vaginal birth. OASIS may have catastrophic consequences, including anal incontinence.
- Trial name
- PROS (NCT05898945)
- Where
- United Kingdom
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- London North West Healthcare NHS Trust
Obstetric; Injury Pelvic Floor, Sexual Dysfunction
Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery
Obstetric anal sphincter injuries (OASIS) cause significant morbidity and are well known risk factors for sexual dysfunction, urinary and anal incontinence.
- Conditions
- Obstetric; Injury Pelvic Floor, Sexual Dysfunction, Anal Incontinence, Urinary Incontinence
- Trial name
- NCT05317364
- Testing
- Estradiol 0.01% Vag Cream
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Alabama at Birmingham
Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
The goal of this observational study is to understand long-term pelvic floor symptoms and sexual dysfunction after childbirth-related anal sphincter injury in women who gave birth at Tampere University Hospital between 2009 and…
- Conditions
- Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries, Pelvic Floor Disorders
- Trial name
- NCT07646340
- Where
- Finland
- Volunteers
- 600 people
- Sponsor
- Tampere University Hospital
Pain, Postpartum Depression
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term.
- Trial name
- NCT03470675
- Testing
- Epidural saline + IV saline, Epidural morphine 3 mg + IV saline, Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Northwestern University
Fecal Incontinence
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal…
- Trial name
- DigniFI (NCT05776277)
- Testing
- Iltamiocel
- Where
- 25 sites in United States
- Volunteers
- 200 people
- Sponsor
- Cook MyoSite
Postpartum Quality of Life, Peripartal Maternal Trauma
Improving Postpartum Quality of Life Through Enhanced Perineal Care Training
This prospective interventional before and after study evaluates whether structured obstetric training-covering perineal protection, improved episiotomy technique, systematic detection of obstetric anal sphincter injuries (OASI)…
- Trial name
- NCT07865065
- Testing
- Obstetric training
- Where
- Czechia
- Volunteers
- 380 people
- Sponsor
- University Hospital Hradec Kralove
Obstetric Anal Sphincter Injury
Use of 3D Ultrasound to Predict Anal Sphincter Defects
Injury to the muscles of the back passage (anal canal) is a relatively common problem. This injury can result in problems with bowel control later in life and usually occurs during vaginal childbirth (commonly referred to as 3rd…
- Trial name
- NCT02655900
- Testing
- Pelvic Floor Ultrasound
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Croydon University Hospital
Anal Sphincter Injury
Prevalence of Obstetric Anal Sphincter Injury With a Reducing Episiotomy Rate
Obstetric anal sphincter injury (OASIS) is a serious complication of a vaginal delivery. High proportion of women, 40-59%, suffer from faecal incontinence (FI) after this type of injury.1-3 OASIS and FI have a negative impact on…
- Trial name
- NCT05436171
- Testing
- No intervention
- Where
- Hong Kong
- Volunteers
- 6,700 people
- Sponsor
- Chinese University of Hong Kong