Health TrialsbyHealthPanel

Hands-on vs Hands-off Techniques in Perineal Protection

ConditionsPerineal TraumaHands-on TechniqueHands-of TechniqueManual Perineal Protection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAzienda ULSS 8 Berica

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Donne incinte nullipare o multipare

Gravidanza a termine

Feto nella presentazione cefalica

Consegna eutocic (spontanea)

Disqualifiers

None

Trial population

Full-term women with spontaneous vaginal birth (SVB)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

737 Participants
are grouped into 2 trial groups
Group A: Hands-off group
Group B: Hands-on group

Trial outcomes

Primary outcomes

1

Perineal outcomes: intact perineum; first-, second-, third-, and fourth-degree perineal tears

Time frame
Within two hours post-delivery
2

Neonatal outcomes: umbilical cord pH

Time frame
within 5 minutes of delivery
3

Neonatal outcomes: Apgar score

Apgar score ≥ 7 at 5 minutes.

Time frame
within 5 minutes of birth

Secondary outcomes

1

Parity

Time frame
Baseline
2

Ethnicity

Time frame
Baseline
3

Fetal malpositions during labor

Time frame
Throughout the entire course of labor
4

Maternal positions assumed during the expulsive phase

Time frame
During the full duration of the second stage of labor

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda ULSS 8 Berica

Lead sponsor

Source ClinicalTrials.gov
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