Skip to content

Comparison of the effect of phenytoin Cream and Honey Cream on episiotomy pain and healing of episiotomy

Compare the effect phenytoin cream and honey cream on pain and healing of episiotomy in nulliparous women

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201405318801N8
Enrollment
120
Registered
2014-09-10
Start date
2014-02-20
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 pain and wound healing. Second degree perineal laceration during delivery

Interventions

Intervention 1: Intervention group: phenytoin sodium, 1% Topical Cream, Once a day. Mothers were asked the night before sleep, after washing and drying the perineal area once a phalanx of ointment on
Treatment - Drugs
Intervention group: phenytoin sodium, 1% Topical Cream, Once a day. Mothers were asked the night before sleep, after washing and drying the perineal area once a phalanx of ointment on the affected ar
Intervention group: Honey cream, 30%. Once a day. Mothers were asked the night before sleep, after washing and drying the perineal area once a phalanx of ointment on the affected area is sutured So th
Control group: Placebo, the cream base color and odor as similar to the intervention group. Once a day. Mothers were asked the night before sleep, after washing and drying the perineal area once a pha

Sponsors

?Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Term and Nulliparous Pregnancy; A literate, between 18-35 of age; race Persia; Living in Kashan; a live singleton fetus with cephalic presentation; birth weight between 2500-4000 grams; BMI In the range of 19.8 to 30; The lack of effect on wound healing drugs (anticoagulants, antidepressants, anticonvulsants, alcohol, glucocorticoids, suppression of the immune system, antibiotics and chemotherapy); narcotics and psychotropic drugs; Disturbing lack of healing diseases (chronic, systemic, cardiac, renal, pulmonary, coagulation disorders, immune deficiency, connective tissue disorders, diabetes, anemia, psychiatric disease, hemophilia, depression, malnutrition) and no history of injury, or previous surgery of lesions visible in the perineum (genital warts, hemorrhoids), persistent constipation; Lack PROM more than 18 hours; lack a history of reactions to local anesthetics or lidocaine; absence of bleeding after childbirth; lack of manual removal of the placenta; the absence of perineal hematoma; No manipulation of the perineum after delivery; failure or anomaly NICU baby; for more than 14 hours not take delivery of the first stage, second stage of labor greater than 2 hours to not take, the third stage of labor not take more than half an hour. Exclusion Criteria: Drugs affecting the healing of wounds (anticoagulants, antidepressants, anticonvulsants, alcohol Glkvkvrtykvyydha, suppressing the immune system, antibiotics and chemotherapy) during the study; Not used regularly and as directed cream; creams desired sensitivity; lack of desire to continue participating in the study; having sex in the first five days after birth; coming to the clinic.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain Intensity. Timepoint: First 24 hours after delivery (baseline value) - Seven days after the intervention - fourteen days after the intervention. Method of measurement: Pain ruler.;Episiotomy wound healing. Timepoint: First 24 hours after delivery (baseline value) - Seven days after the intervention - fourteen days after the intervention. Method of measurement: Control by improving the perineum (the scale Reeda).

Secondary

MeasureTime frame
Stiffness. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.;Irritation. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.;Itching. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.;Dryness. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.;Discharge from the wound. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.;Fever and chills. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoumeh Simbar

School of Nursing and Midwifery Shahid Beheshti

msimbar@sbmu.ac.ir+98 21 8820 2516

Outcome results

None listed

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