Perineal Massage During Labor for the Prevention of Perineal Trauma
Phase: NA
Conditions: Obstetric; Injury Pelvic Floor
Sponsor: Federal University of Rio Grande do Sul

FEDERAL UNIVERSITY OF RIO GRANDE DO SUL  
SCHOOL OF MEDICINE  
GRADUATE PROGRAM IN HEALTH SCIENCES:  
GYNECOLOGY AND OBSTETRICS 
 
 
 
 
 
 
 
 
 
PERINEAL MASSAGE DURING LABOR FOR THE PREVENTION OF 
PERINEAL TRAUMA: A RANDOMIZED CLINICAL TRIAL 
 
 
 
 
 
Project Number in CAAE: 77121923.5.0000.5327 
 
 
 
 
 
 
PORTO ALEGRE 
2024 

Study Protocol 
1. Background and Rationale 
Perineal trauma during childbirth, particularly episiotomy and spontaneous 
lacerations, is associated with pain, prolonged recovery, and complications 
during the puerperium. Evidence from prior meta-analyses (e.g., Aasheim et al., 
Cochrane 2017) suggests potential benefits of perineal massage in reducing 
these outcomes. This study aims to contribute robust evidence through a 
properly randomized, controlled design conducted in a high-volume public 
hospital. 
2. Objectives 
Primary Objective: To evaluate whether perineal massage reduces the 
incidence of intact perineum (absence of episiotomy or laceration) compared to 
standard care. 
Secondary Objectives: To assess differences between groups in the degree of 
lacerations, need for sutures, incidence of episiotomy, neonatal APGAR scores, 
and second stage labor duration. 
3. Study Design 
Type: Interventional, Randomized Controlled Trial 
Model: Parallel Assignment 
Allocation: 1:1 (Massage vs. Control) 
Estimated enrollment: 466 participants 
Location: Hospital de Clínicas de Porto Alegre (HCPA), Brazil 
4. Eligibility Criteria 
Inclusion: 
- Women ≥18 years old 
- Gestational age: 37-42 weeks 
- Cephalic presentation 
- First stage of labor 
- No history of perineal massage in prenatal period 
Exclusion: 
- Cesarean delivery 
- Diagnosis of HELLP syndrome 
- Unstable maternal or fetal vital signs 
Statistical Analysis Plan (SAP) 
1. Overview 
The SAP describes the statistical methods that will be used to analyze the data 
from the trial and to address each primary and secondary objective. 

2. Sample Size Calculation 
Based on Cochrane meta-analysis by Aasheim et al. (2017), a reduction in 
episiotomy rate from 22% to 12% (RR = 0.55) 
Power: 80% 
Sample size: 466 participants (233 per arm) 
3. Population for Analysis 
Full Analysis Set (FAS): all randomized participants, analyzed by original 
assignment (intention-to-treat) 
Per Protocol (PP): participants who adhered to the assigned intervention 
4. Statistical Methods 
Descriptive Statistics: 
- Continuous variables: mean ± SD or median (IQR), depending on normality 
- Categorical variables: frequency and percentage 
Test of Normality: 
- Shapiro-Wilk test 
Between-Group Comparisons: 
- Normal distribution: independent samples t-test 
- Non-normal distribution: Mann-Whitney U test 
- Categorical variables: Pearson Chi-square, Fisher’s exact test, or Yates' 
correction 
Within-Subject Comparisons (Pre/Post if applicable): 
- Normal distribution: paired t-test 
- Non-normal distribution: Wilcoxon signed-rank test 
- Dichotomous categorical variables: McNemar test 
Significance Threshold: 
- Two-sided p-value ≤ 0.05 will be considered statistically significant. 
Missing Data: 
- Assessed for patterns and handled using complete-case analysis or imputation 
if necessary. 
5. Software 
Statistical analysis will be conducted using SPSS for Windows, version 18.0.