Obstetric Anal Sphincter Injury Clinical Trial
Official title:
Diagnosis of Obstetric Anal Sphincter Injuries (OASIs) Using Transperineal Ultrasound Scan (TPUS)
NCT number | NCT03912142 |
Other study ID # | 196995 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 27, 2017 |
Est. completion date | July 30, 2018 |
Verified date | November 2019 |
Source | Lewisham and Greenwich NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
It is common for women to sustain perineal trauma following their first vaginal delivery. Sometimes these can extend to the anal sphincter, and these are referred to as Obstetric Anal Sphincter Injuries (OASIs). Occasionally OASIs may not be detected at delivery. If these tears are missed they would not be repaired and this may lead to incontinence of wind (flatus) or of faeces, both of which can have a significant impact on quality of life. The investigators would like to establish whether a 3D ultrasound scan probe placed outside the vagina can identify the anal sphincter defects and to investigate whether the use of TPUS immediately after primary repair of OASIs is an useful tool to minimise an inadequate repair. The investigators would also like to look at changes that occur to the pelvic floor muscles during labour and to identify injuries to the pelvic floor muscle (levator ani) by ultrasound. Such injury to pelvic floor muscle is associated with vaginal prolapse.
Status | Completed |
Enrollment | 264 |
Est. completion date | July 30, 2018 |
Est. primary completion date | June 29, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - women who are undergoing their first vaginal delivery - 37 weeks of gestation or more - a singleton pregnancy - cephalic presentation - maternal age 18 years old or more and being able to read and understand English. Exclusion Criteria: - Exclusion criteria are those who do not fit in the inclusion criteria. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Lewisham | London |
Lead Sponsor | Collaborator |
---|---|
Lewisham and Greenwich NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic test accuracy of three dimensional and transperineal ultrasound (TPUS) for diagnosing Obstetric Anal Sphincter injurieS (OASIS) | To calculate the diagnostic test characteristics (e.g sensitivity, specificity, positive predictive value, negative predictive value) to enable comparison of 3D TPUS assessment with clinical examination findings of the anal sphincter following vaginal delivery | immediately Postpartum | |
Secondary | Prevalence of Levator Ani Muscle Injury in women who delivered vaginally and by caesarean section | To calculate the prevalence of levator ani muscle avulsion in women after caesarean section and vaginal delivery. | during first and second stage of labour, immediately Postpartum, 3 months Postpartum and 10-12 weeks Postpartum (in women who deliver vaginally) | |
Secondary | Levator ani muscle hiatus area (cm2) | Levator hiatal dimensions can be determined on three dimensional transperineal ultrasound by identifying the plane of minimal dimensions. | during first and second stage of labour, immediately Postpartum, 3 months Postpartum and 10-12 weeks Postpartum (in women who deliver vaginally) | |
Secondary | Fetal head position | Fetal head position is assessed by clinical examination and transabdominal ultrasound. The possible outcomes of both assessments are occiput anterior, occiput posterior or occiput transverse. | during first and second stage of labour | |
Secondary | Fetal head station assessed by clinical examination | Fetal head station is assessed by clinical examination. The fetal station is the relationship of the presenting part to the ischial spines. It is measured in centimetres above or below the ischial spines (+2,+1,0,-1 or -2). | during first and second stage of labour | |
Secondary | Fetal head station assessed by transperineal ultrasound | Transperineal ultrasound is used to assess fetal head station by measuring the angle of progression. Angle of progression is the angle between the longitudinal axis of the pubic bone and a line joining the lowest edge of the pubis to the fetal skull contour. | during first and second stage of labour |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05832268 -
Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
|
||
Completed |
NCT04181840 -
Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection
|
N/A | |
Completed |
NCT04903977 -
Detection of Obstetric Anal Sphincter Injuries With ONIRY Device
|
N/A | |
Recruiting |
NCT04350632 -
Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy
|
N/A | |
Recruiting |
NCT06143072 -
CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence
|
||
Completed |
NCT03769792 -
Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
|
N/A | |
Completed |
NCT02701413 -
Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery
|
N/A | |
Completed |
NCT02655900 -
Use of 3D Ultrasound to Predict Anal Sphincter Defects
|
N/A | |
Completed |
NCT05898945 -
Primary Repair of Obstetric Anal Sphincter Injuries (OASIS) by Surgeons (PROS Study)
|
||
Recruiting |
NCT04446780 -
Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery
|