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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control Group | Placebo Comparator | Standard Intrapartum Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Females
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| Name | Affiliation | Role |
|---|---|---|
| Sumbal Amjad | Sheikh Zayed Medical college/Hospital, Rahimyar Khan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheikh Zayed Medical college/hospital | Rahim Yar Khan | Punjab Province | 75000 | Pakistan |
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| 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. |
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