Pelvic Floor Ultrasound Before Induction of Labour and Labour Outcome

Condition(s) studied

Investigational drug(s) / intervention(s)

Three-dimensional transperineal pelvic floor ultrasound: Transperineal acquisition of 3D/4D pelvic floor volumes at rest, on maximum pelvic floor contraction and on maximum Valsalva manoeuvre, using a transabdominal volumetric probe applied translabially with the woman in the lithotomy position and an empty bladder. Levator hiatal area and diameters are measured offline on the plane of minimal hiatal dimensions using automated segmentation software, with manual tracing as a quality control. No vaginal or rectal probe is used and no ionising radiation is involved. - Other names: TPUS; pelvic floor ultrasound

Study summary

Pregnancy and vaginal birth are the main causes of pelvic floor disorders such as urinary incontinence and pelvic organ prolapse. The levator hiatus - the opening in the pelvic floor muscles through which the baby passes - can be measured on three-dimensional transperineal ultrasound at rest, during pelvic floor contraction and during a Valsalva manoeuvre. Its size and its ability to stretch have been related to how long labour lasts and to how the baby is eventually born, but the evidence comes mostly from women in spontaneous labour, in whom the exact time labour began cannot be established.

Women having their labour induced offer a better model, because the time each stage of labour begins is documented. Recently, automated software has made the measurement of the levator hiatus fast and reproducible, which makes it realistic to use in everyday practice.

This prospective observational study will enrol 140 women with a singleton pregnancy at 36 weeks or more who are scheduled for induction of labour. Before induction begins, each woman will have a transperineal ultrasound scan of the pelvic floor at rest, on maximum contraction and on maximum Valsalva. The scan does not involve any vaginal probe, radiation or injection, and takes about 15 minutes. The times of each phase of labour, the way the baby is born and the condition of the perineum after birth will be recorded prospectively from the clinical record. The scan will be repeated before hospital discharge and about one month after birth, together with validated pelvic floor symptom questionnaires.

The main question is whether the area of the levator hiatus measured on Valsalva before induction is related to the duration of the active, pushing phase of the second stage of labour. The study will also examine the duration of the first stage, the mode of delivery, and how the pelvic floor changes in the first month after an induced birth.

Study procedures do not influence clinical care in any way: induction and labour are managed according to standard departmental protocols, and the research ultrasound results are not disclosed to the clinical team.

Eligibility

Primary outcome measure(s)

• Duration of the active (pushing) second stage of labour — From the onset of active pushing to delivery, assessed up to 4 hours
  Time elapsed from the onset of active maternal pushing to delivery of the fetus, recorded in minutes from the clinical record, analysed in relation to the levator hiatal area measured on maximum Valsalva before induction

Trial sites (1)

More University of Roma La Sapienza trials in Italy

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