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IRCT20260803070513N1 IRCT 2026-08-08 Gonabad University of Medical Sciences Effect of Topical Application of a Cream Containing Hydroalcoholic Extract of Rhus coriaria (Red Sumac) Seeds on the Severity of Episiotomy Pain and Wound Healing in Women Following Vaginal Delivery Effect of Topical Application of a Cream Containing Hydroalcoholic Extract of Rhus coriaria (Red Sumac) Seeds on the Severity of Episiotomy Pain and Wound Healing in Women Following Vaginal Delivery 2026-09-06 anticipated 80 Recruiting https://irct.ir/trial/92275 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were recruited using a continuous (consecutive) sampling method. Women who underwent vaginal delivery with episiotomy and met the study eligibility criteria were enrolled consecutively as they became available. Eligible participants were then randomly assigned to either the intervention or placebo group using block randomization with variable block sizes of four. Initially, the six possible allocation sequences for blocks of four (BBAA, BABA, ABBA, BAAB, AABB, and ABAB) were generated, and each sequence was assigned a number from 1 to 6. Subsequently, a random number between 1 and 6 was selected, and participants were allocated according to the corresponding block sequence, with B representing the intervention group and A representing the placebo group. This process was repeated until the required sample size was achieved, Blinding description: This study was designed as a triple-blind clinical trial. The participants, the researcher administering the intervention, the outcome assessor, and the statistician responsible for data analysis will all be blinded to the treatment allocation. The creams containing hydroalcoholic extract of red sumac (Rhus coriaria) seed and the placebo will be identical in color, odor, consistency, texture, and packaging and will be identified only by a unique code. The collected data will be entered into the statistical software using coded identifiers, and the allocation codes will remain confidential until the completion of the statistical analysis. N/A Pain intensity and episiotomy wound healing. Intervention 1: Intervention group: Following episiotomy repair and transfer of the mother to the postpartum ward, in addition to routine postpartum care, the mother will receive a cream containing hydroalcoholic extract of red sumac seeds. The mother will be instructed to apply a 1–2 cm layer of the cream (depending on the wound size) to the skin of the episiotomy area using a clean finger twice daily, ensuring that the entire length of the skin wound is covered. The application of the cream will continue until the tenth postpartum day. Pain intensity and perineal wound status will be assessed on the first postpartum day, before discharge, the fifth postpartum day, and the tenth postpartum day. Intervention 2: Control group: Following episiotomy repair and transfer of the mother to the postpartum ward, in addition to routine postpartum care, the mother will receive a placebo cream that is similar to the cream containing hydroalcoholic extract of red sumac seeds in terms of appearance, color, odor, consistency, packaging, and method of application, but does not contain the hydroalcoholic extract of red sumac seeds. The mother will be instructed to apply a 1–2 cm layer of the cream (depending on the wound size) to the skin of the episiotomy area using a clean finger twice daily, ensuring that the entire length of the skin wound is covered. The application of the placebo cream will continue until the tenth postpartum day. Pain intensity and perineal wound status will be assessed on the first postpartum day, before discharge, the fifth postpartum day, and the tenth postpartum day. 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 There is no further information.
public Roghayeh Rahmani
Gonabad University of Medical Sciences
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 5027 roghaiehrahmany@yahoo.com Gonabad University of Medical Sciences scientific Roghayeh Rahmani
Gonabad University of Medical Sciences
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 5027 roghaiehrahmany@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Vaginal delivery without the use of instrumental assistance Term pregnancy (38–42 weeks of gestation) Singleton pregnancy with cephalic presentation in mothers with good physical and mental health, based on medical records and maternal history Absence of precipitous or prolonged labor Normal pre-pregnancy body mass index (BMI: 19.8–26 kg/m²) at the beginning of pregnancy (before 12 weeks of gestation), based on medical records and maternal history Willingness to participate in the study and provision of written informed consent Primiparous and secundiparous women (first or second vaginal birth) Maternal age between 18 and 45 years Ability to read and write and communicate effectively with the researcher Routine use of standard prenatal supplements during pregnancy Rupture of membranes lasting no longer than 10 hours before delivery Episiotomy without extension or associated perineal tear No history of substance abuse or use of medications known to interfere with wound healing (e.g., anticoagulants, antidepressants, antiepileptic drugs, or immunosuppressive agents), and no history of hypersensitivity to topical medications, based on maternal self-report Complete spontaneous placental delivery A live, apparently healthy newborn with a normal birth weight (2,500–4,000 g) who roomed-in with the mother No maternal anemia, based on medical records and maternal history Uncomplicated vaginal delivery without any intrapartum complications, as documented in the partograph Mediolateral second-degree episiotomy performed during spontaneous vaginal delivery without complications (e.g., hematoma or the need for interventions beyond routine repair), with repair performed according to the national clinical guideline A healthy, term singleton infant with normal birth weight who did not require hospitalization during the first 10 days of life No history of dermatological disease, systemic disease, psychiatric disorders, genital infections, or pregnancy-related complications, based on medical records and maternal history No use of corticosteroids, immunosuppressive agents, or enoxaparin during pregnancy, based on medical records and maternal history 18 years 45 years Female O90.1 O70 Treatment - Drugs Treatment - Drugs Intervention group: Following episiotomy repair and transfer of the mother to the postpartum ward, in addition to routine postpartum care, the mother will receive a cream containing hydroalcoholic extract of red sumac seeds. The mother will be instructed to apply a 1–2 cm layer of the cream (depending on the wound size) to the skin of the episiotomy area using a clean finger twice daily, ensuring that the entire length of the skin wound is covered. The application of the cream will continue until the tenth postpartum day. Pain intensity and perineal wound status will be assessed on the first postpartum day, before discharge, the fifth postpartum day, and the tenth postpartum day. Control group: Following episiotomy repair and transfer of the mother to the postpartum ward, in addition to routine postpartum care, the mother will receive a placebo cream that is similar to the cream containing hydroalcoholic extract of red sumac seeds in terms of appearance, color, odor, consistency, packaging, and method of application, but does not contain the hydroalcoholic extract of red sumac seeds. The mother will be instructed to apply a 1–2 cm layer of the cream (depending on the wound size) to the skin of the episiotomy area using a clean finger twice daily, ensuring that the entire length of the skin wound is covered. The application of the placebo cream will continue until the tenth postpartum day. Pain intensity and perineal wound status will be assessed on the first postpartum day, before discharge, the fifth postpartum day, and the tenth postpartum day. Severity of episiotomy pain Episiotomy wound healing. Timepoint: Postpartum Day 1, Before Discharge, Postpartum Day 5, and Postpartum Day 10. Method of measurement: Pain intensity will be assessed using the Visual Analog Scale (VAS), and wound healing will be evaluated using the REEDA Wound Healing Scale. Gonabad University of Medical Sciences Approved 2026-02-16 Ethics Committee of Gonabad University of Medical Sciences No. 25, Baharestan Street, Farmandari Town, Qaen City, Qaenat County, South Khorasan Province, Iran Gonabad Razavi Khorasan Iran (Islamic Republic of)