Hands-on versus hands-off perineal protection during vaginal birth
The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.
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 |
|---|---|
| Enrollment | 737 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Azienda ULSS 8 Berica Academic / other |
| Locations | 1 site (Vicenza, Vicenza) |
| Trial ID | NCT07492940 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous randomized trials and meta-analyses have reported mixed results, so there is no definitive consensus on which technique is superior.
Eligibility criteria
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 this trial is running
Vicenza, Vicenza
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.