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.

To compare topical phenytoin, oral Anahil, and their combination versus placebo for episiotomy pain and healing.

A double-blind, placebo-controlled randomized trial of 136 women in four groups.

This study will be conducted at Fatemieh Teaching Hospital in Hamadan, Iran, involving 136 primiparous women following vaginal delivery with episiotomy. Participants will be allocated to four groups: placebo, oral Anahil, topical 1% phenytoin, and combined treatment for 14 days. Pain will be assessed using VAS and wound healing using REEDA by a blinded assessor..

Inclusion: Primiparous women aged 18–40 with BMI 19–26, singleton pregnancy, vaginal delivery with mediolateral episiotomy, no major diseases or wound-healing medications, and written consent. Exclusion: Severe complications, instrumental delivery, wound infection, drug allergy, non-adherence over 20%, interacting medications, or withdrawal.

Group 1 – Control: Standard care, placebo capsules and cream for 14 days. Group 2 – Anahil: Standard care, oral Anahil 500 mg every 12 hours and placebo cream for 14 days. Group 3 – Phenytoin: Standard care, topical phenytoin 1% twice daily and placebo capsules for 14 days. Group 4 – Combined: Standard care, oral Anahil 500 mg every 12 hours and topical phenytoin 1% twice daily for 14 days.

Episiotomy pain (VAS); episiotomy wound healing (REEDA).

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.

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.