levator avulsion
Conditions
Interventions
None listed
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: primiparous at least 6 months after spontanuous vaginal delivery with or without mediolateral episiotomy single birth
Exclusion criteria
Exclusion criteria: Unable to give informed consent instrumental delivery cesarean section predates multiparity malpresentation (non cephalic)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint The differences of a levator avulsion and hiatal dimensions between both groups All analysis of the ultrasound volumes will be performed off line. The investigators will be blinded against the participants* clinical data and therefore unaware of the delivery outcome and if the participant had a mediolateral episiotomy. Levator avulsion will be scored using a scoring system based on Tomographic Ultrasound Imaging. To assess a levator avulsion ultrasound volumes on maximum pelvic floor contraction (PFMC) are used. A multislice technique comparable with the computed tomography is utilized. Slices has to be obtained in the axial plane at 2.5-mm slice intervals, from 5 mm below the plane of minimal hiatal dimensions (see figure 3) to 12.5 mm above that plane, to encompass the entire puborectalis muscle.(29) Levator avulsion is diagnosed if three central slices (reference slice and the slices 2.5 and 5 mm cranial) (i.e. slices 3-5 in figure 4) showed a clearly abnormal muscle insertion, a methodology that has been validated against pelvic organ support data.(30) Good repeatability of the sonographic diagnosis of levator avulsion (* >= 0.7) has been demonstrated by the authors and others. (31-32) Figure 3: Normal anatomy, on the right a midsagittal 2D section and on the left a 3D section. Depicted line is level of minimal hiatal dimension. Figure 4: Tomographic ultrasound imaging, with a slice interval of 2.5 mm, showing a normal levator ani on the right(A) and a right-sided avulsion (marked by *) on the left (B). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in quality of life and pelvic floor symptoms questionnaires between both groups Hiatal measurements of the levator hiatus in contraction, rest and in valsalva. These measurements will be performed whilst doing the off line blinded analysis for detecting levator avulsion. These measurements are shown in figure 5. Figure 5: Measurements in 3D volumes of the anatomy of the pelvic floor and levator ani. Measurement 1 shows the AP(anterior-posterior) diameter of the levator hiatus, measurement 2 the LRI(left-right) diameter of the levator and measurement 3 the hiatal area. | — |
Countries
Netherlands
Outcome results
None listed