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

NCT01045135 | Completed Results

• 1 other identifier: Pelvic floor ultrasound
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric; Injury Pelvic Floor

Keywords

Pelvic organ prolapse; Levator hiatus; 3 and 4 dimensional ultrasound

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Change in Bladder Neck Mobility Measured Via 3D Ultrasound

  gestational week 21 and 37

Other Outcomes (1)

• Health Related Complaints

  20 months

Study Arms (1)

first time delivery

Women giving birth to their first child

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Women giving birth to their first child at Akershus University Hospital, Norway
• Must understand spoken and written Norwegian

You may not qualify if:

• Previous pregnancy of more than 16 weeks
• Serious illness mother or child
• Birth before pregnancy week 32

Sponsors & Collaborators

• University Hospital, Akershus: lead
• The Research Council of Norway: collaborator
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, Akershus, Norway

Location

Related Publications (1)

• Bo K, Hilde G, Staer-Jensen J, Siafarikas F, Tennfjord MK, Engh ME. Does general exercise training before and during pregnancy influence the pelvic floor "opening" and delivery outcome? A 3D/4D ultrasound study following nulliparous pregnant women from mid-pregnancy to childbirth. Br J Sports Med. 2015 Feb;49(3):196-9. doi: 10.1136/bjsports-2014-093548. Epub 2014 Aug 6.

  PMID: 25100734 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

We did not examine the women before they were pregnant and therefore do not have information about how the pelvic floor was before pregnancy. It is therefore possible that we have underestimated the change happening to the levator hiatus.

Results Point of Contact

• Title: Dr.Jette Stær-Jensen, Dr. Franziska Siafarikas
• Organization: Akershus University Hospital

jett@ahus.no

+47-6796000

Study Officials

• Marie E Engh, M.D., PhD

  University Hospital, Akershus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 8, 2010
• Study Start: December 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: June 1, 2013
• Last Updated: February 18, 2019
• Results First Posted: February 18, 2019

Record last verified: 2019-02

Locations

NO (1)