TRESPASS Clinical Study

NCT06443736 | Recruiting DMC

• 1 other identifier: 17506
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Perineal Laceration; Perineal Trauma; Vaginal delivery; Perineal massage; Operative vaginal birth

Outcome Measures

Primary Outcomes (1)

• Rate of intact perineum and perineal tears (classified on the basis of RCOG classification) in the two groups

  The degree of perineal tears will be assessed at the delivery by using the classification system for perineal tears recommended by the Royal College of Obstetricians and Gynaecologists (RCOG classification).

  At the delivery

Secondary Outcomes (5)

• Duration of the second stage of labor in the two groups

  At the delivery

• Rate of operative delivery and episiotomies in the two groups

  During labor and delivery

• Change from the baseline in perineal pain in postpartum using the Numeric Pain Rating Scale (0-10).

  At 7-14-21 days postpartum

• Change from the baseline in perineal pain in postpartum using the Pelvic Pain Impact Questionnaire

  at 45 +/-5 days postpartum.

• Change from the baseline in dyspareunia in postpartum using the Marinoff Dyspareunia Scale

  At 45 +/-5 days postpartum.

Study Arms (2)

Standardized perineal massage

EXPERIMENTAL

Procedure: Standardized perineal massage

Standard prevention

ACTIVE COMPARATOR

Behavioral: Primary prevention

Interventions

Standardized perineal massage PROCEDURE

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.

Standardized perineal massage

Primary prevention BEHAVIORAL

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.

Standard prevention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (1)

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

Udine, 33100, Italy

RECRUITING

MeSH Terms

Conditions

Lacerations

Interventions

Primary Prevention

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Central Study Contacts

Martina Arcieri

CONTACT

+00393478114704; martina.arcieri@asufc.sanita.fvg.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: June 5, 2024
• Study Start: April 19, 2024
• Primary Completion: April 19, 2025
• Study Completion: April 19, 2026
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

IT (1)