TRESPASS Clinical Study

NCT ID: NCT06443736

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-19
• Study Completion Date: 2026-04-19

Brief Summary

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

Detailed Description

Perineal trauma from delivery correlates with an increased incidence of perineal pain and discomfort, dyspareunia and sexual dysfunction, as well as urinary and anal incontinence and therefore have a significant impact on women's physical and mental health. Prepartum perineal massage has been shown to reduce the incidence of spontaneous vagino-perineal tears and promote better anatomo-functional recovery of the perineum in the postpartum period. To date, there are no guidelines on the best modes of perineal massage, and there is a lack of true standardization of the process in the literature. The authors developed, on the basis of the evidence available at the present time, a peculiar type of perineal massage, embedded in a standardized clinical process including training and follow-up of the patient. All pregnant patients who meet the inclusion criteria will be selected and offered participation in the study by delivering the information brochure at the 2nd trimester obstetrical visit. If at the 3rd trimester obstetrical visit the patient expresses willingness to participate in the study, consent will be signed and enrollment and randomization to the study will be performed. The patient will then be notified of the date of the training meeting held by the investigator and/or co-authors; at this meeting, a brief lecture on aspects of primary pelvic floor prevention will be offered to patients in group A, who will also be educated on the perineal massage proposed by the Authors. Group B patients will equally be offered a short lecture on aspects of primary prevention, leaving the patient free choice in pelvic floor education in pregnancy. Group A patients will perform the learned perineal massage at home, reporting their adherence to the study in a diary. After delivery, at the time of discharge, a data collection form regarding postpartum perineal pain will be given to the patient and the date of the 45-day follow-up visit will be communicated. Thus, the primary endpoint of the present study is to assess the difference in incidence in the two study groups of the absence of vagino-perineal tears (intact perineum). Secondary endpoints to be assessed are the superiority of perineal massage on the duration of the second stage of labor, on incidence of operative delivery and episiotomies, and on perineal pain and dyspareunia in postpartum. Investigating the relationship between prepartum perineal massage and perineal tears (and related short- and long-term morbidity) could lead to improvement in obstetric clinical practice by giving the right guidance to the pregnant woman in pelvic floor education.

Conditions

Perineal Laceration, Tear, or Rupture During Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standardized perineal massage

Group Type: EXPERIMENTAL

Standardized perineal massage

Intervention Type: 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.

Standard prevention

Group Type: ACTIVE_COMPARATOR

Primary prevention

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Sanitaria-Universitaria Integrata di Udine

OTHER

Sponsor Role: lead

Responsible Party

Martina Arcieri

Principal Investigator, Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Udine, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Martina Arcieri

Role: CONTACT

martina.arcieri@asufc.sanita.fvg.it

+00393478114704

Facility Contacts

Lorenza Driul

Role: primary

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

17506

Identifier Type: -

Identifier Source: org_study_id