The Effect of Rosa damascene and Phenytoin Cream on pain and episiotomy wound healing

Phase 3

Recruiting

Conditions: G89.18
O90.1
Disruption of perineal obstetric wound
Condition 1: Pain. Condition 2: wound healing.
Other acute postprocedural pain

Registration Number: IRCT20220816055724N1

Lead Sponsor: Arak University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 120

Inclusion Criteria

Normal pregnancy and delivery
Having at least reading and writing literacy
perimiparus
Age between 15-45
Body mass index (after delivery) between 18.5-30 kilograms per square meter

Exclusion Criteria

Gestational age 37-42 , Cephalic presentation, one alive fetuse
suffering from diseases that interfere with wound healing (such as anemia, infection and wounds in the perineum, diabetes, blood pressure, skin, heart, kidney, lung diseases, coagulation disorder, immunodeficiency, hemophilia, disorder connective tissue, depression, malnutrition, mental illnesses, cancer)
using drugs effective on wound healing by the mother (anticoagulants, antidepressants, antiepileptics), alcohol, smoking, glucocorticoids, immune system suppressors, antibiotics, and narcotics and psychotropic drugs, not doing
The duration of rupture of the Amionitic membran is not more than 18 hours
Non-instrumental vaginal delivery with medial and lateral episiotomy incision
having a history of previous injury or surgery and visible lesions in the perineum (genital warts, hemorrhoids) and persistent constipation (according to the patient's statement)
Spontaneous removal of the placenta

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Episiotomy wound pain. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy pain on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: Ruler method- Using the VAS questionnaire.;Repair of episiotomy wound. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo onepisiotomy wound healing on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: Reeda questionnaire.

Secondary Outcome Measures

Name	Time	Method
Drug side effects. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy Burning on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: check list.;Redness. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy redness on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: check list.;Wheal. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy wheal on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: check list.