Obstetric Anal Sphincter Injury Clinical Trial
Official title:
Diagnosis of Obstetric Anal Sphincter Injuries (OASIs) Using Transperineal Ultrasound Scan (TPUS)
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.
Following the first vaginal delivery 85% of women will sustain perineal trauma (1). 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.
Endoanal ultrasound (where an ultrasound probe is inserted directly into the back passage) is
the gold standard diagnostic tool to detect OASIs. It is however not available in most
obstetric units. Transperineal ultrasound (where an ultrasound probe is placed on the
perineum)(TPUS) in contrast is available in most obstetric units and therefore we wish to
determine whether TPUS in addition to a routine clinical examination will increase the
detection rate of OASIs.
Anal incontinence can also occur if the anal sphincter are not repaired adequately. Therefore
we want to investigate whether the use of TPUS immediately after primary repair of OASIs is
an useful tool to minimise an inadequate repair.
The other aim of the study is to look at changes that occur to the pelvic floor muscles
during labour by ultrasound. It is known that certain muscle changes may lead to urinary
incontinence and pelvic organ prolapse. However limited studies have evaluated the natural
history of the pelvic floor muscles in labour. We therefore wish to perform a transperineal
ultrasound each time the midwife or doctor caring for the woman in labour decides the woman
in labour needs a vaginal examination. This will provide important information regarding
changes that occur to the muscles of the pelvic floor during normal labour.
References:
1)Byrd L,Hobbiss J,Tasker M. Is it possible to predict or prevent third degree tears?
Colorectal Dis 2005;7:311-8.
;
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
|