Maghalian Mahsa, Alizadeh Afsaneh, Raphi Fatemeh, Islambulchilar Ziba, Khodaie Laleh, Nabighadim Mahsan, Taghavi Simin, Mirghafourvand Mojgan
Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.
Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.
PLoS One. 2025 Jun 4;20(6):e0325112. doi: 10.1371/journal.pone.0325112. eCollection 2025.
Episiotomy, a common surgical procedure during childbirth, often leads to complications such as pain, infection, and delayed healing. Nigella sativa has demonstrated anti-inflammatory and wound-healing properties in prior studies and have received United States Food and Drug Administration (FDA) approval for food use, indicating their safety. This study aimed to evaluate the efficacy of Nigella sativa emulgel on episiotomy wound healing and pain intensity in primiparous women.
A triple-blind, randomized controlled trial was conducted at Taleghani Hospital, Tabriz, Iran (May 2023-April 2024). Seventy-four primiparous women with mediolateral episiotomy were randomized to receive either Nigella sativa emulgel or placebo, applied topically three times daily for 7 days post-discharge. Wound healing was assessed using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation; primary outcome), and pain intensity was measured via visual analog scale (VAS; secondary outcome). Outcomes were evaluated at discharge (baseline) and 10 ± 1 days postpartum. Data were analyzed using independent t-tests, ANCOVA (adjusted for baseline scores), and Mann-Whitney U tests for non-normal distributions (SPSS v26).
At 10 ± 1 days postpartum, the Nigella sativa group showed significantly better wound healing (REEDA score: MD -0.79, 95% CI -1.20 to -0.39; p = 0.001) and lower pain scores (VAS: MD -0.74, 95% CI -1.3 to -0.11; p = 0.021) compared to placebo. Subscale analysis revealed improvements in redness (p = 0.037), edema (p = 0.041), and ecchymosis (p = 0.043). No adverse effects were reported, and satisfaction was higher in the Nigella sativa group (86.5% vs. 56.7%; p = 0.046).
Topical Nigella sativa emulgel significantly improved episiotomy wound healing and reduced pain intensity, with high patient satisfaction. These findings support its potential as a natural therapeutic option, though larger multi-center trials are needed for broader validation.
Iranian Registry of Clinical Trials IRCT20120718010324N68.
会阴切开术是分娩期间常见的外科手术，常导致疼痛、感染和愈合延迟等并发症。黑种草在先前的研究中已显示出抗炎和促进伤口愈合的特性，并已获得美国食品药品监督管理局（FDA）的食品使用批准，表明其安全性。本研究旨在评估黑种草乳胶对初产妇会阴切开术伤口愈合和疼痛强度的疗效。
在伊朗大不里士的塔莱加尼医院进行了一项三盲随机对照试验（2023年5月至2024年4月）。74例行中侧切会阴切开术的初产妇被随机分为两组，分别接受黑种草乳胶或安慰剂，出院后每天局部涂抹3次，共7天。使用REEDA量表（发红、水肿、瘀斑、分泌物、切口对合情况；主要结局）评估伤口愈合情况，通过视觉模拟量表（VAS；次要结局）测量疼痛强度。在出院时（基线）和产后10±1天评估结局。使用独立t检验、协方差分析（根据基线分数进行调整）以及对非正态分布使用曼-惠特尼U检验进行数据分析（SPSS v26）。
在产后10±1天，与安慰剂组相比，黑种草组的伤口愈合情况明显更好（REEDA评分：MD -0.79，95%CI -1.20至-0.39；p = 0.001），疼痛评分更低（VAS：MD -0.74，95%CI -1.3至-0.11；p = 0.021）。子量表分析显示在发红（p = 0.037）、水肿（p = 0.041）和瘀斑（p = 0.043）方面有所改善。未报告不良反应，黑种草组的满意度更高（86.5%对56.7%；p = 0.046）。
局部使用黑种草乳胶可显著改善会阴切开术伤口愈合并减轻疼痛强度，患者满意度高。这些发现支持其作为一种天然治疗选择的潜力，不过需要更大规模的多中心试验进行更广泛的验证。
伊朗临床试验注册中心IRCT20120718010324N68
