UnknownNot Applicable

TRESPASS Clinical Study

Italy154 participantsStarted 2024-04-19

Plain-language summary

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

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of intact perineum and perineal tears (classified on the basis of RCOG classification) in the two groups

Timeframe: At the delivery

Trial details

NCT IDNCT06443736

SponsorAzienda Sanitaria-Universitaria Integrata di Udine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-19

Contact for this trial

Martina Arcieri

+00393478114704 martina.arcieri@asufc.sanita.fvg.it

View on ClinicalTrials.gov More Perineal Laceration, Tear, or Rupture During Delivery trials