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IRCT20251108067909N1 IRCT 2025-11-18 Ahvaz University of Medical Sciences Evaluation of the Use of Topical Calcipotriol Cream on Pain and Wound Healing Following Episiotomy in Primiparous Women Evaluation of the Use of Topical Calcipotriol Cream on Pain and Wound Healing Following Episiotomy in Primiparous Women: A Randomized Triple-Blind Clinical Trial Study 2025-11-21 anticipated 108 Complete https://irct.ir/trial/87329 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is a randomized, controlled clinical trial with three parallel groups. Participants will be randomly assigned to one of the following three groups: the intervention group, which will receive calcipotriol cream applied to the episiotomy site; the placebo control group, which will receive a placebo cream identical in appearance, color, odor, and packaging to the calcipotriol cream but without the active ingredient; and the no-treatment control group, which will not receive any cream on the episiotomy site, Randomization description: In this study, permutation blocks are used for the characteristics of individuals. First, 9 combinations of three treatments are written as BBAACCABC, CCBBAAABC, CBACBACBA, BACBACBAC, for example. Then, as an example, one of the highly specific combinations can be given to each block to provide the necessary sample, which the individuals selected in this study are collected as, Blinding description: In this study, participants, clinical caregivers, the principal investigator, the outcome assessor, and the data analyst will be blinded to group allocation. The calcipotriol cream and the placebo cream will be identical in color, odor, consistency, and packaging, and will be labeled with numerical codes (e.g., A and B) by an independent individual who will not be involved in the implementation of the study. Only this individual will have knowledge of the actual content corresponding to each code. Participants in the simple control group will not receive any cream; however, their data will be included in the final analysis using anonymous codes, ensuring that the data analyst remains unaware of group assignments. Thus, participants and their caregivers will be blinded to the type of cream (drug or placebo), the data collector will not be informed of group allocation, and data analysis will be performed in a blinded manner based on confidential coding. 2 Episiotomy.. Intervention 1: Intervention group: Women who are experiencing their first childbirth and are scheduled to receive topical calcipotriol cream. Intervention 2: Control group: Women who are experiencing their first childbirth and will not receive calcipotriol cream. Intervention 3: Intervention group: Women who are experiencing their first childbirth and are receiving placebo cream. Yes - There is a plan to make this available What will be shared: All available data from research subjects will be shareable after being de-identified through coding. When: Access to data and documentation will begin at the same time as the results are published. To whom: The data will only be accessible to researchers working in scientific and academic institutions after identifying their identity and the purpose of accessing the data. Conditions: The data will be used to substantiate and more accurately examine the study, as well as to use it for larger studies. Where to obtain: To receive data, please contact the corresponding author of the study at Parvinabedi@ymail.com. How to obtain: To request, send your email to the responsible executive and your request will be responded to within 2-5 business days. Comments:
public Ghazal
Golestan Bolevard, Shahrivar Street
Ahvaz Iran (Islamic Republic of) 613844845 +98 61 3235 6910 ghazalmzade2020@gmail.com Ahvaz University of Medical Sciences scientific Ghazal Mohammadzadeh
Golestan Boulevard, Shahrivar Street
Ahvaz Iran (Islamic Republic of) 6136844845 +98 61 3235 6910 ghazalmzade2020@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) primiparous women who have undergone an episiotomy Vaginal delivery with a mediolateral episiotomy Having provided written informed consent to participate in the study no limit no limit Female Participants with underlying medical conditions such as diabetes, dermatologic diseases, immunodeficiency, or autoimmune disorders were excluded from the study. Women who reported taking supplements or medications containing vitamin D or similar topical creams in the past two weeks. The use of topical or oral medications with potential effects on wound healing. Participants with a known allergy to creams or ointments containing vitamin D. Unwillingness to participate in the study. Rehabilitation Rehabilitation Rehabilitation Intervention group: Women who are experiencing their first childbirth and are scheduled to receive topical calcipotriol cream. Control group: Women who are experiencing their first childbirth and will not receive calcipotriol cream. Intervention group: Women who are experiencing their first childbirth and are receiving placebo cream. Episiotomy wound healing based on REEDA criteria. Timepoint: Days 3-5-10. Method of measurement: Based on the characteristics of redness, inflammation, wound distance, and discharge. Episiotomy pain based on visual pain diagnosis. Timepoint: Day 3,5,10. Method of measurement: Based on visual analogue scale. Women's satisfaction with wound healing and pain reduction. Timepoint: days 3-5-10. Method of measurement: Based on the researcher-made satisfaction form. Ahvaz University of Medical Sciences Approved 2025-11-04 Ethics Committee of Ahvaz Jondishapur University of Medical Sciences Golestan Boulevard, Shahrivar Street Ahvaz Khouzestan Iran (Islamic Republic of)