Clinical Trial Radar

Name: The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.
Creator: Azienda ULSS 8 Berica
Published: 2026-03-25
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07492940 (MPP) for Perineal Trauma, Hands-on Technique, Hands-of Technique, Manual Perineal Protection is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Hands-on vs Hands-off Techniques in Perineal Protection (MPP) 737

Recruiting

Clinical Trial NCT07492940 (MPP) is an observational study for Perineal Trauma, Hands-on Technique, Hands-of Technique, Manual Perineal Protection that is recruiting. It started on 5 March 2026 with plans to enroll 737 participants. Led by Azienda ULSS 8 Berica, it is expected to complete by 1 March 2027. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.

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.

Detailed Description

Perineal trauma remains a frequent occurrence during vaginal childbirth, leading clinicians to adopt various protective strategies. The two primary approaches are the hands-on technique, characterized by active manual support of the perineum and fetal head, and the hands-off (or expectant) technique, which prioritizes spontaneous delivery without manual intervention.

The objective of this study is to compare these t...

Official Title

The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.

Conditions

Perineal TraumaHands-on TechniqueHands-of TechniqueManual Perineal Protection

Other Study IDs

MPP
MF 11
Prot. n. 9674 (Other Identifier) (COMITATO ETICO TERRITORIALE AREA SUD OVEST VENETO)

NCT ID Number

NCT07492940

Start Date (Actual)

2026-03-05

Last Update Posted

2026-03-25

Completion Date (Estimated)

2027-03

Enrollment (Estimated)

737

Study Type

Observational

Status

Recruiting

Keywords

Perineal trauma
Perineal injury
Perineal lacerations
Perineal tears
Obstetric anal sphincter injuries
OASIS
Genital tract trauma
Labial lacerations
Labial tears
Vaginal tears
Pelvic floor muscle injury
Levator ani muscle avulsion
First-degree perineal tear
Second-degree perineal tear
Third-degree perineal tear
Fourth-degree perineal tear
hands on
hands off
hands-on technique
hands-off technique

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
Hands-off group Women receiving hands-off perineal support	N/A
Hands-on group Women receiving hands-on perineal support	N/A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Birth with occiput in sacral rotation		periprocedural
Presence of limb association		periprocedural
Time from head to shoulders delivery		From the delivery of the fetal head until the completion of birth
Birth occurring with the same contraction as the head (single contraction)		From the delivery of the fetal head until the completion of birth.
Type of assistance provided (Hands-on / Hands-off)		Periprocedural
Use of a birthing pool during the expulsive phase or water birth		During active labor and the second stage
Use of lubricants during delivery		During the full duration of the second stage of labor
Application of warm perineal compresses during the expulsive phase		During the full duration of the second stage of labor
Maternal pushing technique and type of assistance provided by the operator		During the full duration of the second stage of labor

Participation Assistant

Eligibility Criteria

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

Azienda ULSS 8 Berica

Study Central Contact

Contact: Jessica Greco, dottoressa, 00390444752628, [email protected]

Contact: Laura Tregnago, dottoressa, 00390444752628, [email protected]

1 Study Locations in 1 Countries

Italy

Vicenza

Ospedale San Bortolo, Vicenza, Vicenza, 36100, Italy

Francesca Carolo, dottoressa, Contact, 0039444757088, [email protected]

Francesca Rigo, dottoressa, Contact, 0039444753053, [email protected]

Recruiting