Actively Recruiting
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
Eligibility Criteria
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
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
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
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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