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

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ClinicalTrials.gov Identifier: NCT01045135
Recruitment Status : Unknown
Verified December 2009 by University Hospital, Akershus.
Recruitment status was:  Recruiting
First Posted : January 8, 2010
Last Update Posted : January 8, 2010
Information provided by:

Study Description
Brief Summary:

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 or disease
Pelvic Floor

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
Study Start Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Groups and Cohorts

first time delivery
Women giving birth to their first child

Outcome Measures

Primary Outcome Measures :
  1. Levator hiatus dimensions [ Time Frame: 20 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045135

Contact: Jette Stær-Jensen, M.D. +47-41140032

Akershus University Hospital Recruiting
Lørenskog, Akershus, Norway
Contact: Jette Stær-Jensen, M.D.    +47-41140032      
Sponsors and Collaborators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: January 8, 2010
Last Verified: December 2009

Keywords provided by University Hospital, Akershus:
Pelvic organ prolapse
Levator hiatus
3 and 4 dimensional ultrasound