Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT06443736

TRESPASS Clinical Study

Led by Azienda Sanitaria-Universitaria Integrata di Udine · Updated on 2024-06-05

154

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to assess the superiority of a standardized perineal massage in the decrease in vagino-perineal lacerations.

CONDITIONS

Official Title

TRESPASS Clinical Study

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Single pregnancy
  • Baby positioned head-down (cephalic presentation)
  • Age between 18 and 40 years
  • Pre-pregnancy body mass index (BMI) between 18 and 29.9
  • Understanding of the Italian language
  • Estimated fetal weight between the 3rd and 97th percentile according to Intergrowth
Not Eligible

You will not qualify if you...

  • Previous pregnancies (multipara)
  • Age under 18 years or over 40 years
  • Pre-existing bladder, sphincter, or perineal disorders
  • Medical reasons preventing vaginal delivery
  • Delivery by cesarean section
  • Pre-pregnancy BMI over 30
  • Estimated fetal weight below the 3rd percentile or above the 97th percentile (over 4500 g) according to Intergrowth
  • Fetal weight at birth over 4500 g
  • Twin pregnancy
  • Preterm delivery before 37 weeks gestation
  • Personal history of connective tissue disease
  • No signed informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ostetrica e Ginecologica Udine

Udine, Italy, 33100

Actively Recruiting

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Research Team

M

Martina Arcieri

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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TRESPASS Clinical Study | DecenTrialz