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Midwife showdown: Hands-On vs Hands-Off for safer births

NCT ID NCT07492940

Knowledge-focused Sponsor: Azienda ULSS 8 Berica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two techniques midwives use during childbirth to protect the perineum from tearing: hands-on (actively supporting the area) and hands-off (letting the birth progress without touch). Researchers will track 737 women giving birth vaginally to see which method leads to fewer tears and better outcomes for both mother and baby. The goal is to identify the safest approach for routine practice.

What this could mean

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

What this could lead to
If successful, this could help midwives choose the best technique to reduce perineal tears during childbirth.
What could go wrong
This is an observational study, not a treatment trial. Results may not apply to all births or settings.

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 737 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

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

Full-term women with spontaneous vaginal birth (SVB)

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Criteri di inclusione: * Donne incinte nullipare o multipare * Gravidanza a termine * Feto nella presentazione cefalica * Consegna eutocic (spontanea) * Uso di ossitocina * Uso di analgesici Criteri di esclusione: * Parto prematuro: prematuro tardivo -Disagio fetale acuto durante la fase di espulsione- * Consegna della gretta * Distocia della spalla * Parto chirurgico (uso del vuoto ostetrico, manovra di Kristeller, taglio cesareo) --Episiotomia

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As listed by the trial registrant

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

Hands-of technique Hands-on technique Manual perineal protection Perineal trauma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ospedale San Bortolo

    RECRUITING

    Vicenza, Vicenza, 36100, Italy

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