Obstetric; Injury Pelvic Floor Clinical Trial
Official title:
The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
Verified date | February 2019 |
Source | University Hospital, Akershus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to
urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%),
sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries
are not easy to diagnose as they are not visible when looking at surface anatomy during a
standard gynaecological examination. The investigators are therefore in urgent need of better
tools to diagnose these injuries. Having a reliable and easily accessible tool enables
studies of the consequences of such pelvic floor muscle injuries. It also makes it possible
for us to explore the effect of interventions such as pelvic floor muscle training and
surgery in patients with and without pelvic floor muscle injuries. The investigators have
previously presented data to support the reliability and the validity of the three and four
dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in
healthy volunteers and have now a tool to study women before and after delivery. At the
Department of Obstetrics and Gynaecology, Akershus University Hospital there are
approximately 4500 deliveries annually and 1500 women are giving birth for the first time.
Challenges: The invitation to participate in the study will be given to all women expecting
their first child fulfilling inclusion criteria. The biggest challenges in the project will
be logistical. To be able to inform, recruit and follow women having their first child is a
challenge in it self.
Applications: If it is possible to identify a risk group for pelvic floor injuries before
delivery, it might be ethical to recommend a prophylactic caesarean section to avoid
disabling incontinence and prolapse later in life.
Status | Completed |
Enrollment | 300 |
Est. completion date | June 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Women giving birth to their first child at Akershus University Hospital, Norway - Must understand spoken and written Norwegian Exclusion Criteria: - Previous pregnancy of more than 16 weeks - Serious illness mother or child - Birth before pregnancy week 32 |
Country | Name | City | State |
---|---|---|---|
Norway | Akershus University Hospital | Lørenskog | Akershus |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Akershus | South-Eastern Norway Regional Health Authority, The Research Council of Norway |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health Related Complaints | 20 months | ||
Primary | Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37. | 3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints giving 3 outcomes | 21 weeks and 37 weeks of gestation | |
Primary | Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37 | 3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints. | 21 weeks and 37 weeks of gestation | |
Primary | Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound | 3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints. | gestational week 21 and 37 | |
Secondary | Change in Bladder Neck Mobility Measured Via 3D Ultrasound | 3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Bladder neck mobility was measured at gestational week 21 and 37, at rest and during Valsalva maneuver . The change in mobility from rest to valsalva was computed between the two different timepoints. | gestational week 21 and 37 |
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