TRESPASS Clinical Study

Launched by AZIENDA SANITARIA-UNIVERSITARIA INTEGRATA DI UDINE · May 30, 2024

Keywords

ClinConnect Summary

The TRESPASS Clinical Study is looking at a method called perineal massage to see if it can help reduce injuries to the vaginal and perineal area during childbirth. This study is currently recruiting women who are between 18 and 40 years old, are expecting their first baby (single pregnancy), and have an average body weight. Participants must also understand Italian and have a baby that is growing normally according to medical standards.

If you decide to take part in this study, you will receive standardized perineal massage during labor to see how it affects the likelihood of getting a laceration or tear. It's important to note that women with certain conditions, like those who have had previous pregnancies, are too young or old, or have complications with their pregnancy or delivery, won't be eligible to participate. This study aims to help improve delivery methods and outcomes for future mothers.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Single pregnancy
• • Part presented cephalic
• • Age between 18 and 40 years
• • Pregravid body mass index (BMI) between 18 and 29.9
• • Understanding of the Italian language
• • Estimated Fetal Weight in range (3rdcentile to 97thcentile according to Intergrowth)
• Exclusion Criteria:
• • Multipara
• • Age \< 18 years and age \> 40 years
• • Presence of pre-pregnancy bladder-sphincter-perineal disorders
• • Medical contraindications to vaginal delivery
• • Birth occurred by cesarean section
• • Pregravid BMI \> 30
• • Estimated Fetal Weight \< 3rdcentile (Small for Gestational Age/Intrauterine Growth Restriction fetus) or \> 97thcentile (\> 4500 g) according to Intergrowth
• • Fetal weight at birth \> 4500 g
• • Twin pregnancy
• • Preterm delivery (\< 37 weeks gestation)
• • Personal history of connective tissue disease
• • Lack of informed consent