An observational study in Obstetric; Injury Pelvic Floor, sponsored by University Hospital, Akershus. Completed at 1 site in Norway. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by University Hospital, Akershus · Observational
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.
University Hospital, Akershus is the lead sponsor of 123 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women giving birth to their first child at Akershus University Hospital, Norway
Exclusion Criteria:
Women giving birth to their first child
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
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
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
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
Health Related Complaints
Time frame: 20 months
January 2010 - july 2011
| Milestone | First Time Delivery |
|---|---|
| Started | 300 |
| Completed | 274 |
| Not completed | 26 |
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
| cm | 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 ± 1.7 |
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.
| cm | Primiparous Women Bladder Neck Mobility Rest to Valsalva Maneu |
|---|---|
| Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37 | 1.2 ± 1.2 |
Results for this outcome have not been posted.
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.
| cm | Primiparous Women Levator Hiatus Area |
|---|---|
| Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound | 3.3 ± 3.5 |
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.
| cm | Primiparous Women Bladder Neck Mobility Rest to Valsalva Maneu |
|---|---|
| Change in Bladder Neck Mobility Measured Via 3D Ultrasound | -0.11 ± 0.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| First Time Delivery | — | — | — |
| Age, Categorical(Participants) | First Time Delivery |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 300 |
| >=65 years | 0 |
| Age, Continuous(years) | First Time Delivery |
|---|---|
| Mean | 28.6 ± 4.2 |
| Sex: Female, Male(Participants) | First Time Delivery |
|---|---|
| Female | 300 |
| Male | 0 |
| Region of Enrollment(participants) | First Time Delivery |
|---|---|
| Norway | 300 |
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Akershus