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

Obstetric; Injury Pelvic Floor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045135
• Other study ID #: Pelvic floor ultrasound
• Status: Completed
• Start date: December 2009
• Est. completion date: June 2013

Study information

• Verified date: February 2019
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric; Injury Pelvic Floor

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog	Akershus

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Akershus	South-Eastern Norway Regional Health Authority, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Related Complaints		20 months
Primary	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
Primary	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
Primary	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	Change in Bladder Neck Mobility Measured Via 3D Ultrasound	3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Bladder neck mobility was measured at gestational week 21 and 37, at rest and during Valsalva maneuver . The change in mobility from rest to valsalva was computed between the two different timepoints.	gestational week 21 and 37