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Ultrasound before induced labor may reveal delivery risks

NCT ID NCT07797387

Knowledge-focused Sponsor: University of Roma La Sapienza Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 01, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

Researchers are testing whether a 3D ultrasound of the pelvic floor, taken before labor is induced, can predict how long labor will last and how the baby will be born. The study will include 140 women with a single baby at 36 weeks or more who are scheduled for induction. Each woman will have a non-invasive ultrasound scan before induction, and the team will track labor times, delivery mode, and pelvic floor changes after birth. The goal is to see if the size and stretch of the levator hiatus, the muscle opening the baby passes through, relates to labor outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Three-dimensional transperineal pelvic floor ultrasound
What this could lead to
If it works, this could help doctors predict labor progress and delivery outcomes before induction, potentially guiding decisions and reducing complications.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The results may not apply to all women, and the ultrasound measurements may not reliably predict outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Consecutive women with a singleton cephalic pregnancy at 36 weeks of gestation or more admitted to the induction of labour service of a tertiary maternity unit, with the intention of vaginal birth, who consent to research pelvic floor ultrasound before the start of cervical ripening.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis Pelvic Floor Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Induced labor LABOR Labor stage, second Levator ani muscle injury Pelvic floor Pelvic floor disorder

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

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

    Roma, RM, 00161, Italy

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