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The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University Hospital, Akershus.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Research Council of Norway
South-Eastern Norway Regional Health Authority
Information provided by:
University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01045135
First received: January 7, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted

January 7, 2010
January 7, 2010
December 2009
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Levator hiatus dimensions [ Time Frame: 20 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Women giving birth to their first child at Akershus University Hospital, Norway

Pelvic Floor
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first time delivery
Women giving birth to their first child
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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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
Female
18 Years to 50 Years
Yes
Contact: Jette Stær-Jensen, M.D. +47-41140032
Norway
 
NCT01045135
Pelvic floor ultrasound
No
Marie Ellstrøm Engh, Phd, associate professor, Akershus University Hospital
University Hospital, Akershus
  • The Research Council of Norway
  • South-Eastern Norway Regional Health Authority
Study Director: Marie E Engh, M.D., PhD University Hospital, Akershus
University Hospital, Akershus
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP