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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Episiotomy Extended by Laceration

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Medical college/hospital

Rahim Yar Khan, Punjab Province, 75000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Medical College

Other Gov

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 28, 2026
Registry last updated: Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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