NCT07492940

Hands-on vs Hands-off Techniques in Perineal Protection

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 737 (estimated)
• Sponsor: Azienda ULSS 8 Berica · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Perineal Trauma
• Hands-on Technique
• Hands-of Technique
• Manual Perineal Protection

Timeline

• Start date: 2026-03-05
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: Italy