TRESPASS Clinical Study

NARecruitingINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

April 19, 2024

Primary Completion Date

April 19, 2025

Study Completion Date

April 19, 2026

Conditions
Perineal Laceration, Tear, or Rupture During Delivery
Interventions
PROCEDURE

Standardized perineal massage

Patients in this arm will be educated in the perineal massage proposed by the authors; the training will be performed during a group session, (organized bimonthly) conducted by obstetrical staff specialists, in the presence of the principal investigator and/or co-authors. In these sessions, a brief lecture on aspects of primary prevention related to pelvic floor structures (healthy diet, body weight control, moderate physical activity avoiding excessive exertion, posture control, therapy minctional education) and then screened an explanatory video regarding the three-step perineal massage proposed by the authors. The adequately prepared patient should then apply such perineal massage at home from the 34th gestational week until delivery according to the procedural methods provided.

BEHAVIORAL

Primary prevention

Patients in this arm will be offered a group meeting in which aspects of primary prevention related to the structures of the pelvic floor (healthy diet, body weight control, moderate physical activity avoiding exertion excessive exertion, posture control, micturition educational therapy); participation in this meeting will be on a voluntary basis, and patients randomized to that group will have free choice in educating the pelvic floor pelvic floor in pregnancy.

Trial Locations (1)

33100

RECRUITING

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

All Listed Sponsors
lead

Azienda Sanitaria-Universitaria Integrata di Udine

OTHER