Clinical trial · Observational
Pelvic Floor Ultrasound Before Induction of Labour and Labour Outcome
Antepartum Three-Dimensional Transperineal Ultrasound Assessment of the Levator Hiatus and Labour Outcome in Women Undergoing Induction of Labour: A Prospective Observational Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Induced Labor | — | UNRESOLVED | — |
| Labor | — | UNRESOLVED | — |
| Labor Stage, Second | — | UNRESOLVED | — |
| Levator Ani Muscle Injury | — | UNRESOLVED | — |
| Pelvic Floor | — | UNRESOLVED | — |
| Pelvic Floor Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Three-dimensional transperineal pelvic floor ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women undergoing induction of labour
- description
- Women with a singleton cephalic pregnancy at 36 weeks of gestation or more, admitted for induction of labour with the intention of vaginal birth, assessed by three-dimensional transperineal pelvic floor ultrasound before induction, before hospital discharge and one month after delivery.
- interventionNames
- Diagnostic Test: Three-dimensional transperineal pelvic floor ultrasound
Primary outcomes (1)
- measure
- Duration of the active (pushing) second stage of labour
- timeFrame
- From the onset of active pushing to delivery, assessed up to 4 hours
- description
- 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
Secondary outcomes (10)
- measure
- Duration of the active phase of the first stage of labour
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria - * Age 18 years or older * Singleton pregnancy with cephalic presentation * Gestational age of 36 weeks 0 days or more, dated by first-trimester crown-rump length * Scheduled for induction of labour with a planned attempt at vaginal delivery, for any clinical indication * Ultrasound assessment feasible before administration of the first cervical ripening agent * Written informed consent Exclusion Criteria - Multiple pregnancy or non-cephalic presentation * Known fetal structural or chromosomal anomaly * Previous caesarean section or previous uterine surgery * Planned caesarean section or a contraindication to vaginal delivery arising before the ultrasound assessment * Connective tissue disease, neuropathy or neuromuscular disease affecting the pelvic floor * Previous pelvic floor or anti-incontinence surgery - Active labour, or ruptured membranes with regular contractions, at the time of the scheduled assessment * Inability to perform an adequate Valsalva manoeuvre or pelvic floor contraction after standardised instruction * Inability to provide informed consent or to understand the study questionnaires
References
Publications (5)
- RESULTDietz HP, Shek C, Clarke B. Biometry of the pubovisceral muscle and levator hiatus by three-dimensional pelvic floor ultrasound. Ultrasound Obstet Gynecol. 2005 Jun;25(6):580-5. doi: 10.1002/uog.1899. PMID 15883982
- RESULTIshii K, Futaki S, Uchiyama H, Nagasawa K, Andoh T. Mechanism of inhibition of mammalian DNA topoisomerase I by heparin. Biochem J. 1987 Jan 1;241(1):111-9. doi: 10.1042/bj2410111. PMID 3032152
- RESULTBrunelli E, Del Prete B, Casadio P, Pilu G, Youssef A. The dynamic change of the anteroposterior diameter of the levator hiatus under Valsalva maneuver at term and labor outcome. Neurourol Urodyn. 2020 Nov;39(8):2353-2360. doi: 10.1002/nau.24494. Epub 2020 Aug 31. PMID 32865824
- RESULTYoussef A, Brunelli E, Pilu G, Dietz HP. The maternal pelvic floor and labor outcome. Am J Obstet Gynecol MFM. 2021 Nov;3(6S):100452. doi: 10.1016/j.ajogmf.2021.100452. Epub 2021 Aug 6. PMID 34365028
- RESULTResta S, De Vito M, Patelli C, Lu JLA, Gabrielli G, Chiodo E, Mappa I, Rizzo G. Validation of an automated software (Smartpelvic) in assessing hiatal area from three dimensional transperineal pelvic volumes of pregnant women: comparison with manual analysis. J Perinat Med. 2023 Nov 9;52(2):165-170. doi: 10.1515/jpm-2023-0323. Print 2024 Feb 26. PMID 37938105