Effect of the phenytoin cream on episiotomy healing and pain reduction

Effect of the phenytoin cream in comparison with placebo on episiotomy healing and pain reduction in woman with vaginal delivery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017080835575N1

Enrollment

Registered

2017-08-20

Start date

2017-08-16

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

episiotomy. complication disruption of episiotomy

Interventions

Intervention 1: Interventional group : Phenytoin 1% Cream. Intervention 2: Control group: Osserin Cream( placebo).

Treatment - Drugs

Placebo

Interventional group : Phenytoin 1% Cream

Control group: Osserin Cream( placebo)

Eligibility

Sex/Gender

Female

Age

17 Years to 34 Years

Inclusion criteria

Inclusion criteria: inclusion criteria : mothers with a term delivery ; women with vaginal delivery and episiotomy incision ; 1 or 2 degree episiotomy incision: not very deep incision ; supporting equipment’s like vacuum were not used in delivery process ; a Medio lateral episiotomy incision ; mothers who are not malnutrition or on specific diet ; first pregnancy ; age between 18 years old until 35 ; not having premature rupture of the membranes (PROM) >18 hr.; not having special disease ( anemia , cardiovascular disease, diabetes mellitus, immune disease, liver disease, depression) ; not smoking or drug user ; ability to read and write ; not being obsess ( BMI < 29) exclusion criteria: use special drugs like corticosteroid ,anticoagulant, immune system suppressors, wide spectrum antibiotics, anti-histamines, Ca antagonist, chemotherapy and radiotherapy, narcotics ; second repairs after delivery; long time delivery or extreme bleeding after delivery ; obstetrician problems like eclampsia, preeclampsia, placenta Previa, twin or triplet pregnancy , coryoamnionitis. meccunial membranes, polyhidrameniosis ; mothers with infections, abscess and hematoma in perinea

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Healing - sevierity of pain. Timepoint: 10 and 20 days after intervention begining. Method of measurement: REEDA scale for healing- VISUAL ANALOG SCALE for sevierity.	—

Secondary

Measure	Time frame
Dehiscence of insicion- scar lenght. Timepoint: 10 and 20 days after begining of intervention. Method of measurement: percent of second reparation- centimeter.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasome Haghighi

Research andinvestigation commite

azimis1@medsab.ac.ir+98 51 4401 1304

Outcome results

None listed

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