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Effect of Phenytoin cream on incision due to normal vaginal delivery

The comparison of the effectiveness of phenytoin cream with placebo on episiotomy healing in primipara women

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201510118611N1
Enrollment
130
Registered
2015-11-09
Start date
2015-10-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Disruption of Episiotomy. Disruption of perineal obstetric wound

Interventions

Intervention 1: Intervention group: phenytoin sodium cream 1% of the drug distribution company Tehran - Iran and Betadine solution purchased 10% of the pharmaceutical company's medipharm Kish - Iran.
Treatment - Drugs
Placebo
Intervention group: phenytoin sodium cream 1% of the drug distribution company Tehran - Iran and Betadine solution purchased 10% of the pharmaceutical company's medipharm Kish - Iran
Control group: Placebo phenytoin sodium cream of the drug distribution company Tehran - Iran and Betadine solution purchased 10% of the pharmaceutical company's medipharm Kish - Iran

Sponsors

Vice-Chancellor for Research of Qazvin University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: The women with 18-35 years old and full term pregnancy (37 to 42 weeks) being nulliparous; no specific diseases (cardiovascular; hepatic; renal; diabetes; coagulopathy diseases; anemia); non- obese (BMI<29; according to the same scale); singelton; cephalic presentation; episiotomy on gynecological bed; time of repair less than 30 minutes; episiotomy repair by chromic catgut sutures. exclusion criteria: Hematomas during and after the repair of episiotomy; extended Episiotomy; excessive bleeding after childbirth; manipulation of the perineum, uterus and cervixe; prolonged rupture of amniotic sac more than 18 hour; use of assistive devices (vacum during delivery); no smoking and alcohol.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Episiotomy wound healing. Timepoint: 24 hours, 5 and 10 days after delivery. Method of measurement: Reeda scale (redness, edema, ecchymosis, discharge, near the edge of the wound).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamideh Pakniat

Qazvin University of Medical Sciences

pakniat110@yahoo.com+98 28 3333 6001

Outcome results

None listed

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