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NCT07797387

Pelvic Floor Ultrasound Before Induction of Labour and Labour Outcome

Sponsor: University of Roma La Sapienza

View on ClinicalTrials.gov

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.

Official title: Antepartum Three-Dimensional Transperineal Ultrasound Assessment of the Levator Hiatus and Labour Outcome in Women Undergoing Induction of Labour: A Prospective Observational Cohort Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

140

Start Date

2026-10-01

Completion Date

2028-11-01

Last Updated

2026-09-03

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

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

Locations (1)

Azienda Ospedaliero-Universitaria Policlinico Umberto I, Department of Maternal and Child Health and Urological Sciences

Roma, RM, Italy