RecruitingNot ApplicableNCT06443736

TRESPASS Clinical Study

Antenatal ThREe Steps Perineal mASSage in Reducing Perineal Trauma and Post-partum Morbidities: TRESPASS Clinical Study


Sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Enrollment

154 participants

Start Date

Apr 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria6

  • 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 Criteria12

  • 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

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Interventions

PROCEDUREStandardized 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.

BEHAVIORALPrimary 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.


Locations(1)

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

Udine, Italy

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NCT06443736


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