TRESPASS Clinical Study
Antenatal ThREe Steps Perineal mASSage in Reducing Perineal Trauma and Post-partum Morbidities: TRESPASS Clinical Study
Azienda Sanitaria-Universitaria Integrata di Udine
154 participants
Apr 19, 2024
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
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
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.
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)
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NCT06443736