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IRCT20260423069137N1 IRCT 2026-05-09 Shahid Beheshti University of Medical Sciences Evaluation of the effect of Pomegranate peel ointment in episiotomy Evaluation of the effect of Pomegranate (Punica granatum) peel extract ointment on pain severity and episiotomy wound healing: a randomized clinical trial 2026-05-21 anticipated 120 Complete https://irct.ir/trial/89727 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a three-group study, Randomization description: Participants will be divided into three groups by random allocation using the Random Allocation software: the group receiving pomegranate peel extract ointment, the group receiving placebo ointment, and the routine care group including washing the wound site with normal saline. Allocation of participants to the groups will be done using random numbers to prevent selection bias, Blinding description: This study will be conducted using a three-blind design. For intervention allocation, pre-determined codes prepared by the pharmacist will be used. Accordingly, drug or placebo ointment and normal saline solution will be assigned in a coded manner by a trained colleague, according to these codes, to the participants. During outcome assessment, the investigator will be unaware of the type of intervention assigned (drug, placebo, or saline wash) and will only record the participant’s code. The statistician will also remain blinded, and code unblinding will be performed only after completion of the statistical analysis. 3 Episiotomy. Intervention 1: Intervention group1: Recipients of pomegranate peel extract ointment. In this study, pomegranate peel was obtained from the herbal market (herbalist shop), and after identity confirmation, it was dried in the shade and powdered using a grinder. Subsequently, the extract was obtained by soaking in methanol. The pure extract was then mixed with Eucerin at a 2% concentration and filled into 60-gram tubes. The filled ointments were autoclaved and finally, applied to the wounds by the study participants, twice a day (every 12 hours) for 10 days. At the beginning of the intervention, all participants in all three groups received uniform training on how to cleanse the perineum with normal saline, 3 times a day for 10 days, dry the area, and maintain general perineal hygiene. In this intervention group, prior to use, a sensitivity test was performed under the supervision of the researcher. A small amount of the ointment was applied to the inner surface of the arm, and if no reaction occurred within 30 minutes, the use of the ointment would commence from the first day after childbirth.Participants in this group, after washing their hands and cleansing and drying the perineum, would apply 2 grams of the ointment evenly to the wound site and use a clean sanitary pad after 1–2 minutes. Ointment application continued twice daily with a 12-hour interval for 10 days. Participants would be instructed to visit the gynecology clinic of Motazeddi Hospital in Kermanshah on the fifth and tenth days after childbirth for evaluation.To follow up with participants, their phone numbers were obtained at the beginning of the study and their accuracy verified through phone calls. Daily reminder text messages were also planned. If participants did not show up at the scheduled times, phone follow-up would be conducted, and evaluations would be performed at their homes with their coordination and consent. Participants would be trained to contact the researcher in case of any problems or complications such as sensitivity, pain, itching, burning, fever, and chills, so that necessary actions could be taken. Intervention 2: Intervention group 2: Recipients of placebo ointment. This ointment contains the base materials of the drug (Eucerin), which is completely similar to the main drug in terms of appearance, color, and consistency, filled into 60-gram tubes, and autoclaved. Finally, it is applied to the wounds by the study participants, twice a day (every 12 hours) for 10 days. At the beginning of the intervention, all participants in all three groups received uniform training on how to cleanse the perineum with normal saline, 3 times a day for 10 days, dry the area, and maintain general perineal hygiene. In this intervention group, prior to use, a sensitivity test was performed under the supervision of the researcher. A small amount of the ointment was applied to the inner surface of the arm, and if no reaction occurred within 30 minutes, the use of the ointment would commence from the first day after childbirth.Participants in this group, after washing their hands and cleansing and drying the perineum, would apply 2 grams of the ointment evenly to the wound site and use a clean sanitary pad after 1–2 minutes. Ointment application continued twice daily with a 12-hour interval for 10 days. Participants would be instructed to visit the gynecology clinic of Motazeddi Hospital in Kermanshah on the fifth and tenth days after childbirth for evaluation.To follow up with participants, their phone numbers were obtained at the beginning of the study and their accuracy verified through phone calls. Daily reminder text messages were also planned. If participants did not show up at the scheduled times, phone follow-up would be conducted, and evaluations would be performed at their homes with their coordination and consent. Participants would be trained to contact the researcher in case of any problems or complications such as sensitivity, pain, itching, burning, fever, and chills, so that necessary actions could be taken. Intervention 3: Control group: Routine care group (Saline solution). In participants of this group, the episiotomy incision site is cleansed with 1000 ml of 0.9% sodium chloride physiological saline solution (product of Iran Injectable and Derivative Company) three times a day for 10 days. After drying, clean sanitary pads are used. The researcher will provide instructions to the participants regarding drying the area and general perineal hygiene. Participants will be informed to visit the gynecology clinic of Motazeddi Hospital in Kermanshah on the fifth and tenth days postpartum for evaluation. To follow up with participants, their phone numbers will be obtained at the beginning of the study, and their accuracy will be verified through telephone calls. Additionally, daily reminder text messages will be sent. If participants do not attend appointments at the scheduled times, telephone follow-up will be conducted, and evaluations will be performed at their homes with their coordination and consent. No - There is not a plan to make this available Justification or reason for not sharing IPD is In case of a logical justification, it will be provided to the journal for publication of the article.
public Sahar Nazarabadi
No. 42, Bostan Alley 5, The beginning of Tehran's old road, Kermanshah city
Kermanshah Iran (Islamic Republic of) 6715914745 +98 83 3424 5007 sahar.nazarabadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Fatemeh Nahidi
Faculty of Nursing & Midwifery, Vali-e Asr Street, at the intersection of Neayesh Avenue, opposite Shahid Rajaee Heart Hospital, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 f.nahidi87@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Gestational age between 37 and 42 completed weeks Maternal age between 18 and 35 years Body mass index (BMI) within the range of 18.6 to 30 Iranian nationality Resident of Kermanshah Province Ability to read and write Singleton pregnancy with cephalic presentation Neonatal birth weight between 2,500 and 4,000 grams Vaginal delivery with mediolateral episiotomy, without perineal tear and without the use of assisted delivery tools (forceps or vacuum) 18 years 35 years Female Prolonged rupture of membranes lasting more than 24 hours Severe anemia during pregnancy (hemoglobin level below 7) Consumer of cigarettes, alcohol, and drugs Presence of any underlying condition that impairs wound healing (including chronic systemic diseases, cardiopulmonary disorders, connective tissue diseases, anemia, diabetes, malnutrition, hemophilia, psychiatric disorders, and renal failure), as well as obstetric complications such as gestational diabetes, preeclampsia, eclampsia, coagulation disorders, placental abruption, chorioamnionitis, and immune system deficiencies, based on the individual’s statement and medical/midwifery records Use of any medications that may affect wound healing, such as corticosteroids, anticoagulants, antiepileptic drugs, immunosuppressants, broad‑spectrum antibiotics, and chemotherapeutic agents Labor dystocia and prolongation of the stages of labor History of hypersensitivity to topical or herbal medications, as reported by the individual O70 Perineal laceration during delivery Treatment - Drugs Placebo Treatment - Drugs Intervention group1: Recipients of pomegranate peel extract ointment. In this study, pomegranate peel was obtained from the herbal market (herbalist shop), and after identity confirmation, it was dried in the shade and powdered using a grinder. Subsequently, the extract was obtained by soaking in methanol. The pure extract was then mixed with Eucerin at a 2% concentration and filled into 60-gram tubes. The filled ointments were autoclaved and finally, applied to the wounds by the study participants, twice a day (every 12 hours) for 10 days. At the beginning of the intervention, all participants in all three groups received uniform training on how to cleanse the perineum with normal saline, 3 times a day for 10 days, dry the area, and maintain general perineal hygiene. In this intervention group, prior to use, a sensitivity test was performed under the supervision of the researcher. A small amount of the ointment was applied to the inner surface of the arm, and if no reaction occurred within 30 minutes, the use of the ointment would commence from the first day after childbirth.Participants in this group, after washing their hands and cleansing and drying the perineum, would apply 2 grams of the ointment evenly to the wound site and use a clean sanitary pad after 1–2 minutes. Ointment application continued twice daily with a 12-hour interval for 10 days. Participants would be instructed to visit the gynecology clinic of Motazeddi Hospital in Kermanshah on the fifth and tenth days after childbirth for evaluation.To follow up with participants, their phone numbers were obtained at the beginning of the study and their accuracy verified through phone calls. Daily reminder text messages were also planned. If participants did not show up at the scheduled times, phone follow-up would be conducted, and evaluations would be performed at their homes with their coordination and consent. Participants would be trained to contact the researcher in case of any problems or complications such as sensitivity, pain, itching, burning, fever, and chills, so that necessary actions could be taken. Intervention group 2: Recipients of placebo ointment. This ointment contains the base materials of the drug (Eucerin), which is completely similar to the main drug in terms of appearance, color, and consistency, filled into 60-gram tubes, and autoclaved. Finally, it is applied to the wounds by the study participants, twice a day (every 12 hours) for 10 days. At the beginning of the intervention, all participants in all three groups received uniform training on how to cleanse the perineum with normal saline, 3 times a day for 10 days, dry the area, and maintain general perineal hygiene. In this intervention group, prior to use, a sensitivity test was performed under the supervision of the researcher. A small amount of the ointment was applied to the inner surface of the arm, and if no reaction occurred within 30 minutes, the use of the ointment would commence from the first day after childbirth.Participants in this group, after washing their hands and cleansing and drying the perineum, would apply 2 grams of the ointment evenly to the wound site and use a clean sanitary pad after 1–2 minutes. Ointment application continued twice daily with a 12-hour interval for 10 days. Participants would be instructed to visit the gynecology clinic of Motazeddi Hospital in Kermanshah on the fifth and tenth days after childbirth for evaluation.To follow up with participants, their phone numbers were obtained at the beginning of the study and their accuracy verified through phone calls. Daily reminder text messages were also planned. If participants did not show up at the scheduled times, phone follow-up would be conducted, and evaluations would be performed at their homes with their coordination and consent. Participants would be trained to contact the researcher in case of any problems or complications such as sensitivity, pain, itching, burning, fever, and chills, so that necessary actions could be taken. Control group: Routine care group (Saline solution). In participants of this group, the episiotomy incision site is cleansed with 1000 ml of 0.9% sodium chloride physiological saline solution (product of Iran Injectable and Derivative Company) three times a day for 10 days. After drying, clean sanitary pads are used. The researcher will provide instructions to the participants regarding drying the area and general perineal hygiene. Participants will be informed to visit the gynecology clinic of Motazeddi Hospital in Kermanshah on the fifth and tenth days postpartum for evaluation. To follow up with participants, their phone numbers will be obtained at the beginning of the study, and their accuracy will be verified through telephone calls. Additionally, daily reminder text messages will be sent. If participants do not attend appointments at the scheduled times, telephone follow-up will be conducted, and evaluations will be performed at their homes with their coordination and consent. Pain intensity score on the Visual Analog Scale for pain. Timepoint: Before intervention (2 hours postpartum) and on the first, fifth, and tenth days postpartum. Method of measurement: Visual Analog Scale. Wound healing score on the Redness, Edema, Echymosis, Discharge, Approximation scale. Timepoint: Before intervention (2 hours postpartum) and on the first, fifth, and tenth days postpartum. Method of measurement: Redness, Edema, Echymosis, Discharge, Approximation scale. Shahid Beheshti University of Medical Sciences Approved 2026-05-03 Ethics Committee/Working Group in Research of the Faculties of Pharmacy, Nursing, and Midwifery — Sh Faculty of Nursing & Midwifery, Vali-e Asr Street, at the intersection of Neayesh Avenue, opposite Shahid Rajaee Heart Hospital, Tehran Tehran Tehran Iran (Islamic Republic of)