The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Pelvic Floor |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound |
- Levator hiatus dimensions [ Time Frame: 20 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2009 |
| Groups/Cohorts |
|---|
|
first time delivery
Women giving birth to their first child
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Women giving birth to their first child at Akershus University Hospital, Norway
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
Contacts and Locations| Contact: Jette Stær-Jensen, M.D. | +47-41140032 |
| Norway | |
| Akershus University Hospital | Recruiting |
| Lørenskog, Akershus, Norway | |
| Contact: Jette Stær-Jensen, M.D. +47-41140032 | |
| Study Director: | Marie E Engh, M.D., PhD | University Hospital, Akershus |
More Information
No publications provided
| Responsible Party: | Marie Ellstrøm Engh, Phd, associate professor, Akershus University Hospital |
| ClinicalTrials.gov Identifier: | NCT01045135 History of Changes |
| Other Study ID Numbers: | Pelvic floor ultrasound |
| Study First Received: | January 7, 2010 |
| Last Updated: | January 7, 2010 |
| Health Authority: | Norway: Ethics Committee Norway: Data Protection Authority |
Keywords provided by University Hospital, Akershus:
|
Pelvic organ prolapse Levator hiatus 3 and 4 dimensional ultrasound |
ClinicalTrials.gov processed this record on May 22, 2013