Clinical trial NCT01045135: The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
Official title: The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric; Injury Pelvic Floor
Keywords: Pelvic organ prolapse
Levator hiatus
3 and 4 dimensional ultrasound
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: South-Eastern Norway Regional Health Authority
First posted: 2010-01-08
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women giving birth to their first child at Akershus University Hospital, Norway

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.


Eligibility 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

Primary outcomes:
measure: Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37.
timeFrame: 21 weeks and 37 weeks of gestation
measure: Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37
timeFrame: 21 weeks and 37 weeks of gestation
measure: Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound
timeFrame: gestational week 21 and 37
Secondary outcomes:
measure: Change in Bladder Neck Mobility Measured Via 3D Ultrasound
timeFrame: gestational week 21 and 37
Other outcomes:
measure: Health Related Complaints
timeFrame: 20 months
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Marie E Engh, M.D., PhD
role: STUDY_DIRECTOR
References:
citation: 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.