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
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • 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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045135

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

Locations
Norway
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
Investigators
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 August 01, 2014