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IRCT20221227056938N2 IRCT 2023-04-28 Ahvaz University of Medical Sciences The effect of topical grape seed cream on episiotomy wound healing The effect of topical grape seed cream on episiotomy wound healing in primiparous women: a double-blind randomized controlled clinical trial 2023-05-21 anticipated 60 Complete https://irct.ir/trial/69705 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: ampling will be done by the available method, in such a way that pregnant women after delivery who refer to the hospital of Ahvaz University of Medical Sciences due to candidal vaginitis and are eligible to enter the study are selected. The research units will be assigned to two intervention and control groups using the random block method (six blocks). In this way, the 6 possible states of the blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB) will be listed first. And each block will be assigned a number from one to six. Then a number between one and six is randomly selected using the random number table, and then people are selected based on the block corresponding to the number. will be assigned to the intervention (A) and control (B) groups. This work will continue until the sample volume is completed, Blinding description: Grape cream and placebo cream will be made by the pharmacist and both grape cream and placebo will be coded (A, B).Two tubes of medicine of the same shape, same color, same texture and weight will be prepared, one tube has an active substance and the other one does not have an effective substance.The research unit and the researcher will not know the type of medicine in the cans of Kedar. 3 Episiotomy wound healing.. Intervention 1: Intervention group: grape seed cream, which will be made in Jundishapur Faculty of Pharmacy of Medical Sciences. To prepare medicine, 35 empty metal tubes of 50 grams with 2% grape seed cream will be prepared and filled with 50 grams of tube from Tolo Gostar Bukhara company/along with an applicator/Using grape seed ointment on the episiotomy wound every night for a week. Intervention 2: Control group: Using placebo on the episiotomy wound every night for a week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Fatemeh Razavinia
Golestan, Ahvaz, Khuzestan, Iran
Ahvaz Iran (Islamic Republic of) 6135815751 +98 911 210 3403 fatemehrazavinia15@gmail.com Ahvaz University of Medical Sciences scientific Fatemeh Razavinia
Golestan, Ahvaz, Khuzestan, Iran
Ahvaz Central African Republic 6135815751 09112103403 fatemehrazavinia15@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Term pregnancy (37-42) primiparous singleton Age 18 to 35 years Being literate in reading and writing Absence of obesity after childbirth (BMI of the samples should not be higher than 29, measured with the same scale) Willingness to participate in the study 18 years 35 years Female Having a special diet Having a specific disease (anemia, cardiovascular diseases, diabetes, immune, liver, depression and active skin disease, history of diseases that interfere with wound healing, chronic constipation) Allergy to herbal medicines and the use of medicines that interfere with wound healing Having a symptomatic infection in the vagina and vulva (infectious discharge, itching, burning) Having lesions of the anus, vulva and mesentery, hematoma during hospitalization Smoking, alcohol and drugs Disturbance in the stages of childbirth (prolongation of the stages of childbirth and dystoshia) and instrumental delivery (use of vacuum) Heavy bleeding after childbirth Re-manipulation of perineum after childbirth and extension of episiotomy Not using medicine regularly Patient's refusal to continue participating in the study Treatment - Drugs Placebo Intervention group: grape seed cream, which will be made in Jundishapur Faculty of Pharmacy of Medical Sciences. To prepare medicine, 35 empty metal tubes of 50 grams with 2% grape seed cream will be prepared and filled with 50 grams of tube from Tolo Gostar Bukhara company/along with an applicator/Using grape seed ointment on the episiotomy wound every night for a week Control group: Using placebo on the episiotomy wound every night for a week Episiotomy healing. Timepoint: in 24 hours after birth, day 7 and 14 after birth. Method of measurement: Based on the Rida system. Ahvaz University of Medical Sciences Approved 2023-04-03 Ethics committee of Ahvaz University of Medical Sciences Ahvaz-Golestan highway-next to Golestan bazaar-corner of Waliasr street-Golestan girls' dormitory complex-Golestan building 2 Ahvaz Khouzestan Iran (Islamic Republic of)