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TRESPASS Clinical Study

NCT06443736 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-06-05

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Azienda Sanitaria-Universitaria Integrata di Udine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2025-04-19
Completion
2026-04-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06443736 on ClinicalTrials.gov