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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
| South-Eastern Norway Regional Health Authority | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| first time delivery | Women giving birth to their first child |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Complaints | 20 months |
Inclusion Criteria:
Exclusion Criteria:
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Women giving birth to their first child at Akershus University Hospital, Norway
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| Name | Affiliation | Role |
|---|---|---|
| Marie E Engh, M.D., PhD | University Hospital, Akershus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | Akershus | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25100734 | Derived | 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. |
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January 2010 - july 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | First Time Delivery | Women giving birth to their first child |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | First Time Delivery | Women giving birth to their first child |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | cm | 21 weeks and 37 weeks of gestation |
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Serious and other (non-serious) adverse effects were not collected/assessed, as this was an observational cohort study with no intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | First Time Delivery | Women giving birth to their first child |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Jette Stær-Jensen, Dr. Franziska Siafarikas | Akershus University Hospital | +47-6796000 | jett@ahus.no |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 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. | Posted | Mean | Standard Deviation | cm | 21 weeks and 37 weeks of gestation |
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| Other Pre-specified | Health Related Complaints | Not Posted | 20 months | Participants |
| 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. | Posted | Mean | Standard Deviation | cm | gestational week 21 and 37 |
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| 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. | Posted | Mean | Standard Deviation | cm | gestational week 21 and 37 |
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