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

Sheikh Zayed Medical College

Status: Active, not recruiting

Conditions: Episiotomy Extended by Laceration

Treatments: Other: Standard Intrapartum Care Group (Control); Procedure: Intrapartum perineal massage

Study type: Interventional

Funder types: Other

Identifiers

NCT07374497

Sheikh ZMC/H4

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups, including a placebo group

Intrapartum Perineal Massage Group

Experimental group

Description:

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.

Treatment:

Procedure: Intrapartum perineal massage

Control Group

Placebo Comparator group

Description:

Standard Intrapartum Care

Treatment:

Other: Standard Intrapartum Care Group (Control)