Aim of the study is to get informed on the outcome of women treated in the MUMC for obstetric anal sphincter injury between 2005 and 2012. The controlgroup is matched for maternal age at delivery, parity, mode of delivery and child weigth.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
- Maternal complications of labour and delivery
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
anal incontinence
Secondary outcome
abnormalities in the sphincter on endoanal ultrasound (persistent defects)
abnormalities in sphincter function om endoanal manometry
risc factors for developing anal incontinence after obstyetric anal sphincter
injury
risk of recurrent obstetric anal sphincter defect in a subsequent vaginal
delivery
incidence of urine incontinence
Background summary
The last Dutch study on outcome after obstetric anal sphincter injury is
published in 2001 and described a prevalence of fecal incontinence after
obstetric anal injury of 31%(de Leeuw et al). As a result of publications on
the bad outcome of women after obstetric anal sphincter injury there has been a
growing attention for this subject the last 20 years. The recognition of
sphincter injuries, the importance of both the internal and external sphincter
and the pros and cons of different suture techniques have been under the
attention. It is possible that the incidence of anal incontinence after
obstetric anal sphincter injury has changed and perhaps has improved.
Since there is no structural follow-up of these women, the outcome for women in
the current time in the netherlands is unknown.
Study objective
Aim of the study is to get informed on the outcome of women treated in the MUMC
for obstetric anal sphincter injury between 2005 and 2012. The controlgroup is
matched for maternal age at delivery, parity, mode of delivery and child
weigth.
Study design
An observational retrospective cohort study and case control study, with
prospective follow-up.
Study burden and risks
The endoanal ultrasonography and anorectal manometry are both invasive
diagnostic tools, which are painless and without any risk, but can be a burden
for a patient undergoing the exams. Filling in the questionnaires is time
consuming and can be a burden because personal questions are asked on
continence status. The risk for any adverse event in the study is very low.
There is no benefit for the subjects in joining the study.
Debyelaan 25
Maastricht 6202 AZ
NL
Debyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
- All women with a history of a first-ever obstetric anal sphincter injury in the period 2005-2012.
- Diagnosis and treatment of an obstetric anal sphincter injury in the MUMC
- Willing to give informed consent
- Capable of understanding the Dutch language and the given information
- Minimum age of 18 years ;Control group:
- All women with a delivery in the period 2005-2012 in the MUMC
- No diagnosis and treatment of an obstetric anal sphincter injury.
- Permission to informed consent
- Capable of understanding the Dutch language and the given information
- Minimum age of 18 years
Exclusion criteria
- no Permission to informed consent
- not Capable of understanding the Dutch language and the given information
- age < 18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47537.068.13 |