Effect of Perineal Massage on the Frequency of Episiotomy and Perineal Tearing

January 20, 2026 updated by: Kainat usman, Sheikh Zayed Medical College
A randomized controlled trial was conducted at the Department of Obstetrics and Gynaecology, Sheikh Zayed Hospital, Rahim Yar Khan, over 6 months following Institutional Review Board and College of Physicians and Surgeons Pakistan approval, to assess whether intrapartum perineal massage reduces mediolateral episiotomy and lowers the frequency and severity of perineal tears in women undergoing term (37-42 weeks), singleton, cephalic vaginal delivery. Women aged 18-45 years in active labour who provided written informed consent were consecutively enrolled and randomized (1:1) by a computer-generated sequence with sequentially numbered, opaque, sealed envelopes to either standard intrapartum care or standard care plus perineal massage; women with conditions requiring urgent delivery/caesarean section or contraindicating vaginal delivery/perineal manipulation were excluded. In the intervention arm, a trained doctor performed standardized perineal massage using sterile water-based lubricant during the first stage and again near the second stage, with predefined stopping criteria for safety; the control arm received routine care without massage beyond usual perineal support at delivery. Primary outcomes were episiotomy (Yes/No) and perineal tear occurrence and grade (first-fourth), assessed immediately post-delivery by a consultant obstetrician not involved in providing massage.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Rahim Yar Khan, Punjab Province, Pakistan, 75000
        • Sheikh Zayed Medical college/hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-45 years
  • Primigravida and multigravida women in active labor.
  • Singleton, cephalic presentation of the fetus.
  • Women who provide informed consent to participate in the study.
  • Women at Term pregnancy (37 - 42 weeks).

Exclusion Criteria:

  • Women with placental abruption, vaginal bleeding, macrosomia, fetal distress, vaginal infections, placenta previa and preterm births.
  • Non-vertex fetal presentations such as breech.
  • Women scheduled for a cesarean section.
  • Pregnancies with multiple gestations (e.g., twins, triplets).
  • Presence of active genital herpes or other contraindications to vaginal birth (HIV).
  • Active vaginal infections, including bacterial vaginosis or yeast infections.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrapartum Perineal Massage Group
Women received routine intrapartum care plus standardized intrapartum perineal massage performed by a trained doctor during the first stage of labour (repeated sessions) and an additional session as the second stage approached, using a sterile water-based obstetric lubricant.
Procedure: Intrapartum perineal massage
Standardized technique with gloved hands and water-based lubricant; thumbs introduced ~2-3 cm into the vagina with steady lateral pressure to vaginal side walls during resting intervals, delivered as 10-minute sessions repeated during first stage of labour, with an additional session near second stage; discontinued if bleeding, severe pain, suspected infection, non-reassuring fetal status, or urgent obstetric indication arose.
Placebo Comparator: Control Group
Standard Intrapartum Care
Other: Standard Intrapartum Care Group (Control)
Women received routine intrapartum care only, with no perineal stretching or massage manoeuvres beyond routine perineal support during delivery, as per hospital protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of episiotomy
Time Frame: Immediately at the time of delivery (during second stage and recorded immediately after birth)
Proportion of participants in whom a mediolateral episiotomy was performed during vaginal delivery, based on predefined clinical indications and documented by the consultant obstetrician.
Immediately at the time of delivery (during second stage and recorded immediately after birth)
Frequency of perineal tears
Time Frame: Immediately after birth (post-delivery examination in the labour room)
Proportion of participants with any spontaneous perineal laceration after vaginal delivery, determined on systematic post-delivery perineal and vaginal examination by the consultant obstetrician.
Immediately after birth (post-delivery examination in the labour room)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Zayed Medical College

Investigators

  • Principal Investigator: Sumbal Amjad, Sheikh Zayed Medical college/Hospital, Rahimyar Khan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2025

Primary Completion (Estimated)

February 10, 2026

Study Completion (Estimated)

February 10, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sheikh ZMC/H4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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