Obstetric; Injury Pelvic Floor
Conditions
Keywords
Pelvic organ prolapse, Levator hiatus, 3 and 4 dimensional ultrasound
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.
Interventions
None listed
Sponsors
The Research Council of Norway
South-Eastern Norway Regional Health Authority
University Hospital, Akershus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37. | 21 weeks and 37 weeks of gestation | 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 |
| Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37 | 21 weeks and 37 weeks of gestation | 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. |
| Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bladder Neck Mobility Measured Via 3D Ultrasound | 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. 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. |
Other
| Measure | Time frame |
|---|---|
| Health Related Complaints | 20 months |
Countries
Norway
Participant flow
Recruitment details
January 2010 - july 2011
Participants by arm
| Arm | Count |
|---|---|
| First Time Delivery Women giving birth to their first child | 300 |
| Total | 300 |
Baseline characteristics
| Characteristic | First Time Delivery |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 300 Participants |
| Age, Continuous | 28.6 years STANDARD_DEVIATION 4.2 |
| Region of Enrollment Norway | 300 participants |
| Sex: Female, Male Female | 300 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 21 weeks and 37 weeks of gestation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primiparous Women Levator Hiatus Area During Valsalva Maneuver | Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37 | 1.2 cm | Standard Deviation 1.2 |
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
Time frame: 21 weeks and 37 weeks of gestation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primiparous Women Levator Hiatus Area During Valsalva Maneuver | Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37. | 2.0 cm | Standard Deviation 1.7 |
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.
Time frame: gestational week 21 and 37
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primiparous Women Levator Hiatus Area During Valsalva Maneuver | Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound | 3.3 cm | Standard Deviation 3.5 |
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.
Time frame: gestational week 21 and 37
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primiparous Women Levator Hiatus Area During Valsalva Maneuver | Change in Bladder Neck Mobility Measured Via 3D Ultrasound | -0.11 cm | Standard Deviation 0.8 |
Other Pre-specified
Health Related Complaints
Time frame: 20 months