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IRCT20261008071352N1 IRCT 2026-10-16 Hamedan University of Medical Sciences Evaluation of the effects of topical phenytoin and oral bromelain on wound healing and pain reduction following episiotomy Evaluation of the Effects of Topical Phenytoin and Oral Bromelain on Episiotomy Wound Healing Progress and Pain Reduction in Primiparous Women: A Randomized Controlled Trial. 2026-11-21 anticipated 136 Pending https://irct.ir/trial/93964 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: articipants will be randomly allocated to the study groups at the individual level, using an allocation ratio of 1:1:1:1. A block randomization method with variable block sizes will be used to generate the allocation sequence in order to maintain a relative balance in the number of participants across the four groups while reducing the predictability of subsequent allocations. The randomization sequence will be generated using statistical software or a validated computer-based random number generation tool. After obtaining informed consent, each eligible participant will be assigned to one of the four groups according to the predetermined randomization sequence: the control group, the oral Anahil group, the topical 1% phenytoin cream group, or the combined treatment group. Stratified randomization will not be used. To ensure allocation concealment, the randomization sequence will be held by an individual independent of the participant recruitment and outcome assessment processes. The allocation of each participant will remain concealed from the researcher responsible for recruitment and the outcome assessor until the participant has been enrolled in the study and their eligibility has been confirmed. Outcome assessments will be performed by an assessor who is blinded to group allocation, Blinding description: In this study, participants and outcome assessors will be blinded to group allocation. To maintain participant blinding, an oral placebo and a topical placebo corresponding to the study interventions will be used. These placebos will be made as similar as possible to the active products in terms of appearance, color, odor, and packaging. Outcome assessments, including episiotomy wound healing using the REEDA scale and pain intensity using the VAS scale, will be performed by a trained midwife or obstetrician who is independent of the group allocation process. The outcome assessor will not have access to information regarding participants’ allocation to the study groups. Access to the group allocation list will be restricted to authorized personnel who require this information for study implementation. The blinding status of the principal investigator and other research team members will be determined according to their respective responsibilities in participant allocation, patient care, data collection, and data analysis. Where feasible, data analysis will also be performed using coded group labels, without the analyst being aware of the interventions represented by each code. The group codes will be revealed after the primary analysis has been finalized. Before enrollment, participants will be informed about the nature of the study, the potential interventions, the randomization procedure, and their rights, and written informed consent will be obtained. N/A Episiotomy Wound. Intervention 1: Control group: Participants will receive standard post-episiotomy care. For 14 days, a placebo capsule will be taken every 12 hours, and a placebo cream will be applied twice daily. Intervention 2: Intervention Group 1: Oral Anahil 500 mg every 12 hours, combined with placebo cream, for 14 days. Intervention 3: Intervention Group 2: Topical phenytoin 1% cream applied twice daily, combined with placebo capsules, for 14 days. Intervention 4: Intervention Group 3: Oral Anahil 500 mg every 12 hours, combined with topical phenytoin 1% cream applied twice daily, for 14 days. 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 The decision regarding sharing de-identified individual participant data will be made after completion of the study, taking into account data confidentiality, ethics committee requirements, and the policies of Hamadan University of Medical Sciences.
public Leila Torkashvand
No. 1, Neshat Alley, Yahyavi Street, Shokriyeh Street, Hamadan.
hamedan Iran (Islamic Republic of) 6516754270 +98 81 3477 5415 l.torkashvand23@gmail.com Hamedan University of Medical Sciences scientific Leila Torkashvand
No. 1, Neshat Alley, Yahyavi Street, Shokriyeh Street, Hamadan, Iran.
hamedan Iran (Islamic Republic of) 6516754270 +98 81 3477 5415 l.torkashvand23@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Women aged 18–40 years body mass index (BMI) of 19–26 kg/m² singleton pregnancy primiparity who undergo vaginal delivery with a mediolateral episiotomy absence of significant underlying medical conditions (including diabetes mellitus, gestational hypertension, coagulation disorders, and hepatic or renal diseases) no use of medications that may affect wound healing (such as corticosteroids and immunosuppressive agents) willingness to participate in the study and provision of written informed consent 18 years 40 years Female Occurrence of severe obstetric complications (such as severe hemorrhage or uterine rupture) instrumental delivery signs of wound infection at baseline a history of hypersensitivity to the study medications non-adherence to the prescribed medication regimen exceeding 20%, use of medications that may interfere with the study interventions (including nonsteroidal anti-inflammatory drugs and anticonvulsants) unwillingness to continue participation in the study. Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Participants will receive standard post-episiotomy care. For 14 days, a placebo capsule will be taken every 12 hours, and a placebo cream will be applied twice daily. Intervention Group 1: Oral Anahil 500 mg every 12 hours, combined with placebo cream, for 14 days. Intervention Group 2: Topical phenytoin 1% cream applied twice daily, combined with placebo capsules, for 14 days. Intervention Group 3: Oral Anahil 500 mg every 12 hours, combined with topical phenytoin 1% cream applied twice daily, for 14 days 1. Episiotomy site pain intensity, measured using the Visual Analog Scale (VAS) score on the specified postpartum assessment days. 2. Episiotomy wound healing, measured using the REEDA scale score, which includes redness, edema, ecchymosis, discharge, and approximation of wound edges, on the specified postpartum assessment days. Timepoint: Episiotomy site pain intensity will be measured using the Visual Analog Scale (VAS) on days 1, 3, 7, and 14 postpartum, and episiotomy wound healing will be assessed using the REEDA scale on days 3, 7, and 14 postpartum. Method of measurement: Pain intensity at the episiotomy site will be measured using the Visual Analogue Scale, and episiotomy wound healing will be assessed using the Redness, Edema, Ecchymosis, Discharge, and Approximation scale. Hamedan University of Medical Sciences Approved 2026-09-26 Ethics committee of Hamedan University of Medical Sciences Fatemyieh Hospital, Pasdaran Street, Hamadan. hamedan Hamadan Iran (Islamic Republic of)