Hands-on versus hands-off perineal protection during vaginal birth
Official title: The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.
Run by Azienda ULSS 8 Berica · NCT07492940 · Data updated 2026-11-12
This study will test whether hands-on or hands-off perineal support during vaginal birth better prevents perineal tears and affects newborn well-being for women delivering head-first at term.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 737 (estimated) |
| Sponsor | Azienda ULSS 8 Berica Academic / other |
| Locations | 1 site (Vicenza, Vicenza) |
| Status | Recruiting |
| Started | March 5, 2026 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT07492940 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women at term with a cephalic (head-first) fetus planning a spontaneous (eutocic) vaginal delivery at the study hospital are the ideal candidates.
✕Probably not a fit
Women with preterm labor, non-cephalic presentation, those requiring operative delivery (vacuum/forceps/cesarean), shoulder dystocia, or planned episiotomy are unlikely to benefit from these findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Perineal tears are common during vaginal childbirth and clinicians use either active manual support of the perineum and fetal head (hands-on) or an expectant approach without manual intervention (hands-off). This observational study compares maternal perineal integrity (intact through 4th-degree lacerations) and neonatal outcomes (umbilical cord pH and 5-minute Apgar ≥7) between the two approaches. Investigators will record parity, ethnicity, duration of the second stage, fetal position and presentation, pushing technique, maternal position, water birth use, warm compresses, lubricants, and operator assistance to adjust analyses. The aim is to identify which approach is associated with fewer severe perineal injuries while maintaining acceptable neonatal measures.
Why it matters
Potential benefit: If one technique is shown to be safer, adopting it could reduce perineal tears and improve short-term neonatal outcomes for term vaginal births.
How similar studies have gone: Previous randomized trials and meta-analyses have reported mixed results, so there is no definitive consensus on which technique is superior.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Ospedale San Bortolo
Vicenza, Vicenza, Italy Recruiting
Study contacts
- Principal investigator: Laura Tregnago, dottoressa — Aulss8 Berica
- Study coordinator: Jessica Greco, dottoressa
- Email: jessica.greco@aulss8.veneto.it
- Phone: 00390444752628
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.