Pelvic Floor Ultrasound Before Induction of Labour and Labour Outcome
NCT07797387 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 140
Last updated 2026-09-03
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.
Conditions
- Labor
- Pelvic Floor Disorder
- Labor Stage, Second
- Induced Labor
- Pelvic Floor
- Levator Ani Muscle Injury
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
Sponsors & Collaborators
-
University of Roma La Sapienza
lead OTHER
Principal Investigators
-
Giuseppe Rizzo · Università Roma Sapienza
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-10-01
- Primary Completion
- 2028-10-01
- Completion
- 2028-11-01
Countries
- Italy
Study Locations
More Related Trials
-
Levator Hiatal Dimensions and Mode of Delivery
NCT05849584 ·Status: WITHDRAWN
-
Intrapartum Ultrasound for Assessment of Fetal Progression
NCT05718180 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Prediction of Delivery Mode by Ultrasound-assessed Fetal Position in Nulliparous Women With Prolonged First Stage of Labor.
NCT05206409 ·Status: COMPLETED
-
Role of Intrapartum Ultrasound in Instrumental Delivery
NCT02899481 ·Status: TERMINATED ·Phase: NA
-
Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
NCT05832268 ·Status: ENROLLING_BY_INVITATION
-
Evaluation of Labor Related Pelvic Floor Changes: A 3D Transperineal Ultrasound Study
NCT02391753 ·Status: COMPLETED
-
Evaluation of Transperineal US in Labour
NCT03471780 ·Status: UNKNOWN
-
Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
NCT03769792 ·Status: COMPLETED ·Phase: NA
-
In Vivo Assessment of the Elastic Properties of Women's Pelvic Floor During Pregnancy
NCT03602196 ·Status: UNKNOWN ·Phase: NA
-
Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure: Pilot Observational Study.
NCT04544488 ·Status: UNKNOWN ·Phase: NA
-
Impact of Pelvic Floor Musculature on Peripartum Outcomes
NCT01208246 ·Status: COMPLETED
-
Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care
NCT01905644 ·Status: COMPLETED ·Phase: NA
-
Value of Measuring Cervical Angle and Length by Ultrasound in Prediction of Successful Induction of Delivery
NCT03113227 ·Status: COMPLETED ·Phase: NA
-
Normal and Pathological Values of Postvoiding Residual Volume in Early Postpartum Period and Their Predisposing Factors
NCT03958279 ·Status: TERMINATED
-
INTRAPARTUM TRANSPERINEAL ULTRASOUND MEASUREMENT OF HEAD-PERINEUM DISTANCE
NCT07736183 ·Status: COMPLETED
-
Sonopartogram. The Next Step in the Delivery Room
NCT02326077 ·Status: SUSPENDED
-
Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation
NCT06296134 ·Status: RECRUITING ·Phase: NA
-
Prediction of Preterm Delivery With Serial Cervical Length Measurements After Threatened Preterm Labor
NCT05044143 ·Status: COMPLETED
-
Intrapartum Ultrasonography in Evaluation of the Progress of Labor
NCT05823610 ·Status: UNKNOWN
-
Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma
NCT03518684 ·Status: COMPLETED ·Phase: PHASE4
-
Decision-Making in Labor Admission Using Transperineal Ultrasound vs. Vaginal Examination
NCT07278271 ·Status: RECRUITING ·Phase: NA
-
The Effect of Crowning Time on Levator Ani Muscle Avulsion
NCT07210788 ·Status: RECRUITING
-
Diagnosis of Obstetric Anal Sphincter Injuries (OASIs) Using Transperineal Ultrasound Scan (TPUS)
NCT03912142 ·Status: COMPLETED
-
Maternal and Perinatal Outcome in Women With History of Premature Labor in Previous Pregnancy
NCT01375439 ·Status: COMPLETED ·Phase: NA
-
Can Ultrasound Predict Labor Outcome in Operative Vaginal Deliveries?
NCT01878591 ·Status: COMPLETED