Clinical trials: Obstetric Anal Sphincter Injury
Perineal Tear, Obstetric Trauma
Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture
Anovaginal distance measured by palpation and perineal ultrasound are similar.
- Trial name
- AVD and OASR (NCT03039582)
- Testing
- Bidigital palpation, Perineal ultrasound
- Volunteers
- 151 people
- Sponsor
- Ostergotland County Council, Sweden
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 Anal Sphincter Injury
Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy
The risk prediction of obstetric anal sphincter injury couyl be optimized by considering pregnant women's anal sphincter intrinsic viscoelastic properties.
- Trial name
- SEA ELASTO 1 (NCT04350632)
- Testing
- Shear wave elastography assessment of the external anal sphincter
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Poitiers University Hospital
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 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, 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
Pelvic Floor Disorders, Obstetric Trauma
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
This is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into…
- Conditions
- Pelvic Floor Disorders, Obstetric Trauma, Urinary Incontinence, Anal Incontinence
- Trial name
- DeliverUU (NCT05530681)
- Testing
- Questionnaire, Pelvic floor ultrasound
- Where
- Belgium
- Volunteers
- 320 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Complication of Labor and Delivery
Palestinian Perineum and Birth Complication Study
In this study the investigators want to assess complications associated to pregnancy and delivery, and interventions used during labor. Pregnancy and delivery related complications are a major health problem globally.
- Trial name
- PPS (NCT02427854)
- Testing
- Education by animated training video, Interactive hands-on bedside training
- Where
- 4 sites in Palestinian Territories
- Volunteers
- 51,041 people
- Sponsor
- Oslo University Hospital
Anal Sphincter Tear Complicating Delivery
Peripartum Ultrasound in the Prediction and Diagnosis of OASIs
To determine the value of peripartum scan measurement(s) in the prediction and diagnosis of Obstetric Anal Sphincter Injuries (OASIs)
- Trial name
- NCT05046704
- Testing
- peripartum transperineal Ultrasound
- Where
- Egypt
- Volunteers
- 1,250 people
- Sponsor
- Cairo University
Obstetric Anal Sphincter Injury
A Comparison of THD® Anopress With High Resolution Anorectal Manometry
Currently, high resolution anorectal manometry (HDARM) is used as gold standard to measure anal sphincter pressures in women who have sustained a third or fourth degree perineal tears (obstetric anal sphincter injuries).
- Trial name
- NCT07083908
- Testing
- THD® Anopress (Sensyprobe) first, High Resolution Anorectal Manometry first
- Where
- United Kingdom
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- King's College Hospital 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
Sphincter (Anal); Perineal Rupture, Obstetric, Perineal Tear
One Plus One Equals Two, Will That do?
A new clinical practice to reduce perineal trauma has been adopted by many maternity wards in Sweden. This practice involves collegial midwifery assistance during the second stage of labor and the birth of the baby.
- Conditions
- Sphincter (Anal); Perineal Rupture, Obstetric, Perineal Tear, Pelvic Floor Disorders, Experience, Life
- Trial name
- Oneplus (NCT03770962)
- Testing
- Two midwives
- Where
- 4 sites in Sweden
- Volunteers
- 3,058 people
- Sponsor
- Region Skane
Fecal Incontinence
Treatment of Fecal Incontinence After Obstetric Anal Sphincter Injuries
Fecal incontinence (FI), the involuntary loss of solid or liquid stool, is a stigmatising condition. It can have a distressing impact and restriction on quality of life.
- Trial name
- KISS (NCT01528995)
- Testing
- Medtronic Interstim II-3058, Anal bulking injection
- Where
- Norway
- Volunteers
- 68 people
- Sponsor
- University Hospital of North Norway
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
Anal Incontinence
Impact on Postpartum Anal Incontinence of an Educational Program for Delivery Room Staff
Obstetric anal sphincter injuries are a source of significant short-term (pain, bleeding, infection, suture dehiscence), medium-term (anorectovaginal fistulas, sexual dysfunction), and long-term (anal incontinence in 30-60% of…
- Trial name
- IIA-LOSA (NCT07336017)
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Strasbourg, France
Delivery, Obstetric
The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury
Single-nucleotide polymorphisms (SNP's) in connective tissue components are associated with increased risk of pelvic organ prolapse (POP).
- Trial name
- NCT04047433
- Testing
- screening for single nucleotide polymorphism, whole exome sequencing
- Where
- Israel
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- HaEmek Medical Center, Israel
Sphincter Ani Incontinence, Obstetric Trauma
Physical Therapy for Women With Obstetric Trauma and Anal Incontinence
Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically…
- Trial name
- NCT01672697
- Testing
- Physical Therapy (PT) and Behavioral Therapy (BT)
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- TriHealth Inc.
Obstetric Anal Sphincter Injury
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.
- Trial name
- ADAPT (NCT07667660)
- Testing
- Group Session
- Where
- Denmark
- Volunteers
- 110 people
- Sponsor
- Hanna Jangö
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
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