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Effect of Silybum marianum ointment on wound healing and episiotomy pain in primiparous women

Evaluation the effect of Silybum marianum ointment on episiotomy wound healing and pain intesity in primiparous women.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181110041603N1
Enrollment
90
Registered
2019-08-10
Start date
2019-08-05
Completion date
Unknown
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episiotomy. Disruption of perineal obstetric wound

Interventions

Intervention 1: Intervention group: Silybum marianum ointment (produced in Shahid Beheshti pharmacy faculty) uses topically one finger amount (2cm) on episiotomy wounds twice for 10 days. Interventio
placebo ointment (produced in Shahid Beheshti pharmacy faculty) uses topically one finger amount (2cm) on episiotomy wounds twice for 10 days.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Being primiparous Aged between 18 to 35 years. BMI between 18.5-29.9. Resident in Talesh. literate. Singleton birth with cephalic presentation Appropriate newborn weight( 2500 to 4000 gr) have a vaginal delivery with mediolateral episiotomy. No long-term rupture membrane more than 24 hours. lack medical disease history. Perineal swelling did not occur immediately after episiotomy. No addiction history No allergies to topical drugs. No manual removal of placenta

Exclusion criteria

Exclusion criteria: Mother's reluctance to continue studying. Mother does not use silybum marianum ointment regularly and in accordance with the instructions. Mother should not wash episiotomy and in accordance with the order (less than twice a day). Mother has sex within 10 days of delivery. Perineal has been tampered with after any episiotomy repair. Excessive bleeding occurs in the first 24 hours of delivery.

Design outcomes

Primary

MeasureTime frame
Intensity of episiotomy pain. Timepoint: before intervention, 12 hours, 5 and 10 days postpartum. Method of measurement: Visual Analogue Scale (VAS).;Wound healing of episiotomy. Timepoint: before intervention, 12 hours, 5 and 10 days postpartum. Method of measurement: REEDA scale.

Secondary

MeasureTime frame
Complete episiotomy repair. Timepoint: 10 day after delivery. Method of measurement: REEDA scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Sepideh Hajian

Shahid Beheshti University of Medical Sciences

s.hajian@sbmu.ac.ir+98 21 8865 5366

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026