Primary Objective: 3D ultrasound imaging of the morphological changes of the pelvic floor and the arising of possible defects during labour.
ID
Source
Brief title
Condition
- Other condition
- Maternal complications of labour and delivery
Synonym
Health condition
urine/faecale incontinentie en prolaps ( bekkenbodem)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Not applicable (observational study)
Secondary outcome
Not applicable (observational study)
Background summary
Vaginal delivery may cause denervation of the pelvic floor as well as direct
injury to muscles and connective tissue. These injuries may lead to the
development of stress urinary incontinence, faecal incontinence, voiding
difficulties, chronic obstipation and/or urogenital prolapse. Until now most
studies focused on anal sphincter rupture. Recently researchers have shown more
interest into injuries of the levator ani. Most authors assume that such
defects arise at the time of crowning of the fetal head1. However, proof for
this hypothesis has been lacking due to the inherent limitations of magnetic
resonance imaging and the logistic problems of performing MRI in young
asymptomatic nulliparous pregnant women in late gestation. Nowadays
3-dimensional and 4-dimensional pelvic floor ultrasound is capable of
demonstrating the pubovisceral muscle complex at little cost and with minimal
inconvenience to the patient.
The 3D ultrasound will enable us to examine what happens at which moment to the
pelvic floor during labour.
Study objective
Primary Objective: 3D ultrasound imaging of the morphological changes of the
pelvic floor and the arising of possible defects during labour.
Study design
This study is designed as a pilot observational study and will be conducted in
the Erasmus Medical Centre. We will include ten healthy primimara women and
perform a 3-dimensional transperineal pelvic floor ultrasound once before
labour, two times during labour (3-5 cm dilation and 5-9 cm dilation), and
three times after labour (2-24 hours after delivery, 6 weeks after delivery, 3
months after delivery). By this means we will hopefully learn more about the
pelvic floor dynamics during labour, our special interest concerns the levator
ani.
Study burden and risks
We will perform six transperineal 3D ultrasound examinations in all subjects.
The first examinations will be performed before labour, the second and third
during labour. They will have no influence on the progress or timepath of
labour. There are no further risks for mother or child.
The first examination after labour will still take part in the delivery room
(2-24 hours after delivery). The ultrasound six weeks after delivery will be
combined with the general follow-up. There will be one extra appointment for
the examination three months after the delivery.
Buitenwatersloot 108
2613 SV Delft
Nederland
Buitenwatersloot 108
2613 SV Delft
Nederland
Listed location countries
Age
Inclusion criteria
primiparous women
>37weeks PMA
induction of labour
Exclusion criteria
Multiparous women
<37 weeks PMA
malpresentation (non cephalic presentation)
previous pelvic floor trauma
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 | NL24205.078.08 |