NCT07492940

Brief Summary

Perineal tears are frequent during vaginal delivery. This study evaluates the impact of hands-on versus hands-off techniques on perineal and neonatal outcomes to determine the most effective protective strategy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
737

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Mar 2026Mar 2027

Study Start

First participant enrolled

March 5, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 13, 2026

Last Update Submit

March 20, 2026

Conditions

Perineal TraumaHands-on TechniqueHands-of TechniqueManual Perineal Protection

Keywords

Perineal traumaPerineal injuryPerineal lacerationsPerineal tearsObstetric anal sphincter injuriesOASISGenital tract traumaLabial lacerationsLabial tearsVaginal tearsPelvic floor muscle injuryLevator ani muscle avulsionFirst-degree perineal tearSecond-degree perineal tearThird-degree perineal tearFourth-degree perineal tearhands onhands offhands-on techniquehands-off technique

Outcome Measures

Primary Outcomes (3)

  • Perineal outcomes: intact perineum; first-, second-, third-, and fourth-degree perineal tears

    Within two hours post-delivery

  • Neonatal outcomes: umbilical cord pH

    within 5 minutes of delivery

  • Neonatal outcomes: Apgar score

    Apgar score ≥ 7 at 5 minutes.

    within 5 minutes of birth

Secondary Outcomes (14)

  • Parity

    Baseline

  • Ethnicity

    Baseline

  • Fetal malpositions during labor

    Throughout the entire course of labor

  • Maternal positions assumed during the expulsive phase

    During the full duration of the second stage of labor

  • Duration of the second stage of labor

    During the full duration of the second stage of labor

  • +9 more secondary outcomes

Study Arms (2)

Hands-off group

Women receiving hands-off perineal support

Hands-on group

Women receiving hands-on perineal support

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIndividuals identifying as women with birthing capacity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Full-term women with spontaneous vaginal birth (SVB)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Bortolo

Vicenza, Vicenza, 36100, Italy

RECRUITING

Study Officials

  • Jessica Greco, dottoressa

    Aulss8 Berica

    STUDY DIRECTOR

  • Laura Tregnago, dottoressa

    Aulss8 Berica

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Greco, dottoressa

CONTACT

00390444752628jessica.greco@aulss8.veneto.it

Laura Tregnago, dottoressa

CONTACT

00390444752628laura.tregnago@aulss8.veneto.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 25, 2026

Study Start

March 5, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

IT(1)