Evaluation the effect of Silybum marianum ointment on episiotomy wound healing and pain intesity in primiparous women.

Determination of the effect of silybum marianum ointment on episiotomy wound healing and pain intesity in primiparous women.

Clinical trials with control group, with parallel groups, blind, randomized.

This randomized double-blind controlled trial will be performed in Talesh shahid noorani hospital on primiparous women. The participants will be selected based on the inclusion criteria and allocated into groups A and B. Both groups will take ointments twice a day for 10 days. They will be checked at 12th hour, 5th and 10th day after childbirth and in each visit perineal pain intensity and wound healing will be evaluated usingVAS(Visual Analogue Scale) and REEDA (Redness(R),Edema (E),Ecchymosis(E),Discharge from the wound(D) ,Approximation of the perineal tissues) scoring scale. Finally at 10th day of postpartum, two groups will be compared for pain and wound healing.

Inclusion criteria: being primiparous; aged between 18 to 35 years; have a vaginal delivery with mediolateral episiotomy; singleton birth with cephalic presentation; literate; resident in Talesh; appropriate newborn weight ( 2500 to 4000 gr); lack medical disease history; no allergies to topical drugs; No long-term rupture membrane more than 24 hours; No addiction history; BMI between 18.5-29.9; no manual removal of placenta. Exclusion criteria:lack of regular or correct ointment using;Unwillingness to continue studying;Excessive bleeding occurs in the first 24 hours of delivery; having sexual intercourse during the first 10 days after birth.

Intervention group:silybum marianum ointmen uses topically one finger amount on episiotomy wounds twice for 10 days. In control group; placebo cream uses topically one finger amount on episiotomy wounds twice for 10 days.

wound healing of episiotomy

Random numbers will be used to randomize and assign individuals to groups; the randomization using Excel software is as follows: First, in a column, the groups are entered as A, B, and below, since the number of samples in each group is 45 (including sample loss), therefore, 45, B, A should be repeatedly and regularly be. In the opposite column, random numbers are generated using the RAND command. In the next step, using the order command, random numbers are generated from small to large or vice versa, which makes the order of groups A, B change. By using the new order, people are assigned to different groups.

Blind technique will be double-blind, and the investigator and none of the patients will be aware of the type of medication. The drugs are labeled with A, B, C and D labels and given to patients. To conceal the allocation of individuals, the drugs are numbered in the same boxes, depending on the order of allocation. Interventions are stored in closed packet envelopes and are periodically numbered. To hide the allocation of individuals, envelopes are rotated periodically and only after the name and other characteristics of the participant are written on the appropriate envelope.