Clinical trial NCT06443736: TRESPASS Clinical Study
Official title: Antenatal ThREe Steps Perineal mASSage in Reducing Perineal Trauma and Post-partum Morbidities: TRESPASS Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perineal Laceration, Tear, or Rupture During Delivery
Keywords: Perineal Laceration
Perineal Trauma
Vaginal delivery
Perineal massage
Operative vaginal birth
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of intact perineum and perineal tears (classified on the basis of RCOG classification) in the two groups
timeFrame: At the delivery
Secondary outcomes:
measure: Duration of the second stage of labor in the two groups
timeFrame: At the delivery
measure: Rate of operative delivery and episiotomies in the two groups
timeFrame: During labor and delivery
measure: Change from the baseline in perineal pain in postpartum using the Numeric Pain Rating Scale (0-10).
timeFrame: At 7-14-21 days postpartum
measure: Change from the baseline in perineal pain in postpartum using the Pelvic Pain Impact Questionnaire
timeFrame: at 45 +/-5 days postpartum.
measure: Change from the baseline in dyspareunia in postpartum using the Marinoff Dyspareunia Scale
timeFrame: At 45 +/-5 days postpartum.
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ostetrica e Ginecologica Udine
Study officials:
References: