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

NCT07374497 | Active Not Recruiting

• 1 other identifier: Sheikh ZMC/H4
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Episiotomy Extended by Laceration

Keywords

Perineal massage; Vaginal delivery; Episiotomy; Perineal laceration; Perineal tear; Obstetric perineal injury

Outcome Measures

Primary Outcomes (2)

• Frequency of episiotomy

  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

  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)

Study Arms (2)

Intrapartum Perineal Massage Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

Standard Intrapartum Care

Other: Standard Intrapartum Care Group (Control)

Interventions

Intrapartum perineal massage PROCEDURE

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.

Intrapartum Perineal Massage Group

Standard Intrapartum Care Group (Control) OTHER

Women received routine intrapartum care only, with no perineal stretching or massage manoeuvres beyond routine perineal support during delivery, as per hospital protocols.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh Zayed Medical college/hospital

Rahim Yar Khan, Punjab Province, 75000, Pakistan

Location

Study Officials

• Sumbal Amjad

  Sheikh Zayed Medical college/Hospital, Rahimyar Khan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: September 10, 2025
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

PA (1)