Antenatal ThREe Steps Perineal mASSage in Reducing Perineal Trauma and Post-partum Morbidities: TRESPASS Clinical Study
Phase: NA
Conditions: Perineal Laceration, Tear, or Rupture During Delivery
Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

 
 
1 
Version 1.4 of 20.02.2024 
SOC CLINICA OSTETRICIA- GINECOLOGIA  
S. Maria della Misericordia 
P.le S. Maria della Misericordia, 15 – 33100 Udine 
tel. Segreteria Ambulatoriale 0432559695 
e-mail: lorenza.driul@uniud.it 
Direttore: Prof.ssa Lorenza Driul  
 
Antenatal ThREe Steps Perineal mASSage in reducing perineal trauma and post-partum 
morbidities: TRESPASS clinical study  
PROTOCOL SYNOPSIS  
Title 
Antenatal ThREe Steps Perineal mASSage in reducing perineal trauma and post-partum 
morbidities: TRESPASS clinical study  
Sponsor 
 
Azienda Sanitaria Universitaria Friuli Centrale (ASUFC) 
Principal investigator 
Dott.ssa Martina Arcieri 
Study collaborators 
Dott. G. Baccarini, Dott.ssa E. Barbui, Dott.ssa A. Citossi, Dott. S. Floris, Dr.ssa C. 
Giorgiutti, Dott. S. Restaino, Dr.ssa V. Tius, Prof. G. Vizzielli,  
Rationale 
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. 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. 
Endpoint 
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.  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. 
Type 
Prospective randomized superiority trial. 
Participating centers 
ASUFC - Clinic of Obstetrics-Gynecology, Santa Maria della Misericordia Hospital of 
Udine 
Study duration 
2 years 
Period of observation 
2024-2026 
Sample size 
154 patients (77 for each arm).  
Statistical analysis 
Quantitative variables will be described with mean and standard deviation; qualitative 
variables will be summarized in percentages and frequency indices. Continuous and 
categorical data will be compared with Student's t test and Fisher's exact test, respectively. 
Relationships between the data will be expressed using Relative Risk with confidence 
intervals. A p-value < 0.05 will be considered statistically significant. 
Population and data 
sources 
Pregnant women referred to the Udine Obstetrics Clinic who meet the inclusion criteria. 
Data are collected from the patient history and clinical interview, medical records and 
partograms, data collection form and written questionnaires; they will be entered into a 
computerized database in which the patient's name will be replaced by a progressively 
increasing number to preserve anonymity. 
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)  
Study design 
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 

 
 
2 
Version 1.4 of 20.02.2024 
SOC CLINICA OSTETRICIA- GINECOLOGIA  
S. Maria della Misericordia 
P.le S. Maria della Misericordia, 15 – 33100 Udine 
tel. Segreteria Ambulatoriale 0432559695 
e-mail: lorenza.driul@uniud.it 
Direttore: Prof.ssa Lorenza Driul  
 
 
Udine, 20.02.2024 
 
Principal investigator,   
 
 
  
Dott.ssa Martina Arcieri 
 
 
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. 
Bibliograpby 
1. Beckmann MM, Stock OM. Antenatal perineal massage for reducing perineal 
trauma. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD005123. doi: 
10.1002/14651858.CD005123.pub3. PMID: 23633325. 
2. Ahmed Mohamed Abdelhakim et al <Antenatal perineal massage benefits in 
reducing perineal trauma and postpartum morbidities: a systematic review and 
meta-analysis of randomized controlled trials= The International Urogynecological 
Association 2020 
3. Chen Q, Qiu X, Fu A, Han Y. Effect of Prenatal Perineal Massage on Postpartum 
Perineal Injury and Postpartum Complications: A Meta-Analysis. Comput Math 
Methods Med. 2022 Jul 14;2022:3315638. doi: 10.1155/2022/3315638. PMID: 
35872935; PMCID: PMC9303122. 
4. Lucena da Silva M, Andressa Bastos Primo de Sousa Santos T, Wane Carvalho 
Leite L, Emanoel Chaves da Silva C, Oliveira do Nascimento A, Teixeira Alves A, 
Driusso P, da Costa Cunha K. The effectiveness of interventions in the prevention 
of perineal trauma in parturients: A systematic review with meta-analysis. Eur J 
Obstet 
Gynecol 
Reprod 
Biol. 
2023 
Apr;283:100-111. 
doi: 
10.1016/j.ejogrb.2023.02.008. Epub 2023 Feb 17. PMID: 36827751. 
5. Ugwu EO, Iferikigwe ES, Obi SN, Eleje GU, Ozumba BC. Effectiveness of 
antenatal perineal massage in reducing perineal trauma and post-partum 
morbidities: A randomized controlled trial. J Obstet Gynaecol Res. 2018 
Jul;44(7):1252-1258. doi: 10.1111/jog.13640. Epub 2018 Apr 2. PMID: 29607580. 
6. http://intergrowth21.ndog.ox.ac.uk/ 
7. Third- and Fourth-degree Perineal Tears, Management (Green-top Guideline No. 
29) 
[Internet]. 
RCOG. 
[citato 
15 
maggio 
2023]. 
Disponibile 
su: 
https://www.rcog.org.uk/guidance/browse-all-guidance/green-topguidelines/third-
and-fourth-degree-perineal-tears-management-green-top-guideline-no-29/ 
8. Marchi A, Bo ED, Cristiani AM, Cavalieri A. RACCOMANDAZIONI AIO PER 
LE OSTETRICHE. 
9. Ismail SIMF, Emery SJ. Patient awareness and acceptability of antenatal perineal 
massage. J Obstet Gynaecol. 2013;33:839–43. 
 
Notes 
Version 1.4 of 20.02.2024