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

Evaluation of the Effectiveness of Topical Calcipotriol Cream on Pain and Wound Healing Following Episiotomy in Primiparous Mothers.

This study is a randomized, triple-blind, parallel-design clinical trial aimed at evaluating the effect of calcipotriol cream on perineal pain intensity, episiotomy wound healing, and satisfaction among primiparous women. The study will be conducted in the obstetrics and gynecology departments of teaching hospitals in Ahvaz. The study population includes primiparous women who undergo vaginal delivery with mediolateral episiotomy. After obtaining written informed consent and assessing eligibility criteria, participants will be randomly assigned to either the intervention group (calcipotriol cream) or the control group (placebo). Wound healing, pain intensity, and patient satisfaction will be evaluated during the follow-up period. Considering a potential 20% dropout rate, the sample size was determined to be 36 participants per group, for a total of 108 participants.

A randomized, triple-blind clinical trial will be conducted on primiparous women with mediolateral episiotomy to compare the effects of calcipotriol cream, placebo, and standard care. Wound healing, pain intensity, and patient satisfaction will be assessed. All participants and study personnel will be blinded to group allocation.

Primiparous women who have undergone episiotomy. Vaginal delivery with mediolateral episiotomy. Provided written informed consent to participate in the study.

All primiparous women who undergo episiotomy.

Perineal pain intensity, episiotomy wound healing process, and the level of satisfaction of women regarding wound improvement and pain reduction following episiotomy.

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.

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.

All available data from research subjects will be shareable after being de-identified through coding.

Access to data and documentation will begin at the same time as the results are published.

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.

The data will be used to substantiate and more accurately examine the study, as well as to use it for larger studies.

To receive data, please contact the corresponding author of the study at Parvinabedi@ymail.com.

To request, send your email to the responsible executive and your request will be responded to within 2-5 business days.