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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Perineal Trauma; Hands-on Technique; Hands-of Technique; Manual Perineal Protection

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 two methods by evaluating their impact on both maternal and neonatal health.

Study Endpoints

The research focuses on primary outcomes related to perineal integrity-ranging from an intact perineum to varying degrees of lacerations (1st through 4th degree)-and neonatal well-being, specifically monitoring umbilical cord pH and Apgar scores (≥ 7 at 5 minutes).

To ensure a comprehensive analysis, the study also accounts for several secondary variables that may influence these outcomes:

Maternal & Clinical Factors: Parity, ethnicity, and the duration of the second stage of labor.

Delivery Dynamics: Fetal malpositions, presentation at birth (including occiput posterior/sacral rotation), limb associations, and the transition time from head to shoulder delivery.

Procedural Interventions: The specific pushing technique used, maternal positions during the expulsive phase, and the use of water (birthing pool or water birth).

Supportive Measures: The application of warm compresses, the use of lubricants, and the specific assistance provided by the healthcare operator during the final contraction.

• Study Type: Observational
• Enrollment (Estimated): 737

Contacts and Locations

• Study Contact: Name: Jessica Greco, dottoressa; Phone Number: 00390444752628; Email: jessica.greco@aulss8.veneto.it
• Study Contact Backup: Name: Laura Tregnago, dottoressa; Phone Number: 00390444752628; Email: laura.tregnago@aulss8.veneto.it

Study Locations

• Italy
  • Vicenza
    • Vicenza, Vicenza, Italy, 36100
      • Recruiting
      • Ospedale San Bortolo
      • Contact: Francesca Carolo, dottoressa; Phone Number: 0039444757088; Email: francesca.carolo@aulss8.veneto.it
      • Contact: Francesca Rigo, dottoressa; Phone Number: 0039444753053; Email: francesca.rigo@aulss8.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Full-term women with spontaneous vaginal birth (SVB)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hands-off group; Women receiving hands-off perineal support
Hands-on group; Women receiving hands-on perineal support

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	Time Frame
Ethnicity	Baseline
Parity	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

Collaborators and Investigators

• Sponsor: Azienda ULSS 8 Berica
• Investigators: Study Director: Jessica Greco, dottoressa, Aulss8 Berica; Principal Investigator: Laura Tregnago, dottoressa, Aulss8 Berica

Study record dates

Study Major Dates

• Study Start (Estimated): March 5, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: OASIS; Perineal trauma; Perineal tears; Pelvic floor muscle injury; Obstetric anal sphincter injuries; Perineal injury; Perineal lacerations; Genital tract trauma; Labial lacerations; Labial tears; Vaginal tears; 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
• Other Study ID Numbers: MF 11; Prot. n. 9674 (Other Identifier: COMITATO ETICO TERRITORIALE AREA SUD OVEST VENETO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No