RecruitingNot 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 range18 Years – 40 Years

SexFEMALE

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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

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