Teixeira Thaís Trevisan, Riesco Maria Luiza
School of Nursing, University of São Paulo. Midwife in clinical practice at Casa Angela Birth Center, Brazil.
School of Nursing, University of São Paulo, Brazil.
Int J Nurs Stud Adv. 2023 May 12;5:100130. doi: 10.1016/j.ijnsa.2023.100130. eCollection 2023 Dec.
Perineal tears in vaginal birth are highly prevalent and may be related to physical and psychological trauma. Surgical glues are an alternative repair method to avoid the pain that may be caused by perineal repairs with sutures.
To evaluate the effectiveness of surgical adhesive glue in reducing perineal pain when compared to sutures in first-degree perineal tears resulting from vaginal birth.
Open-label parallel-group randomised controlled trial.
An alongside birth centre in Sao Paulo, Brazil.
84 intrapartum women with first-degree perineal tears needing repair.
In the experimental group ( = 42), the perineal tears were repaired with Epiglu® surgical glue (ethyl-2-cyanoacrylate); in the control group ( = 42), the tears were repaired with Vicryl Rapide® (polyglactin 910) sutures. The primary outcome was the intensity of perineal pain after birth measured by a numeric pain rating scale ranging from 0 to 10 points. The secondary outcomes were healing, measured by the "Redness, Oedema, Ecchymosis, Discharge, and Approximation" scale; women's satisfaction with the perineal repair, measured by a visual analogue scale; and the time necessary to complete the repair. Data were collected during postpartum hospitalisation and 10-20 days after discharge, from December 2020 to May 2021. Data were analysed using bivariate analysis and linear models by intention-to-treat.
36-48 h after birth, the mean of perineal pain was 0.2 (95% Confidence Interval [CI] 0.1-0.8) in the experimental group and 0.9 (95% CI 0.5-1.5) in the control group; the perineal healing score was 0.7 (95% CI 0.4-1.2) and 0.8 (95% CI 0.5-1.2), in the experimental and control groups, respectively; satisfaction was higher among women in the experimental group (88.1% versus 83.3% in the control group). After discharge, the mean of perineal pain was 0.1 (95% CI 0.0-0.5) in the experimental group and 1.4 (95% CI 0.8-2.2) in the control group; the perineal healing score was 0.0 (95% CI 0) and 1.0 (95% CI 0.7-1.3) in the experimental and control groups, respectively. Satisfaction was higher in the experimental group (94.9% versus 75.0%). The longitudinal analysis showed statistically significant differences between the groups regarding perineal pain and women's satisfaction. The average time necessary for perineal repair was 6.0 (95% CI 4.7-8.7) minutes in the experimental group and 9.7 (95% CI 8.3-11.5) in the control group ( < 0.001).
Surgical glue resulted in less perineal pain, faster repair, and greater satisfaction than perineal sutures after birth. The healing process was similar in both cases.
Surgical glue was less painful and promoted greater satisfaction after birth compared to sutures in women with first-degree perineal tears.
Registered on The Brazilian Clinical Trials Registry number RBR-52y5tq (http://www.ensaiosclinicos.gov.br/rg/RBR-52y5tq/), on July 16, 2020. The first recruitment was on December 17, 2020.
阴道分娩时会阴撕裂非常普遍，可能与身体和心理创伤有关。手术胶水是一种替代修复方法，可避免会阴缝合修复可能引起的疼痛。
评估与阴道分娩导致的一度会阴撕裂缝合术相比，手术粘合胶水在减轻会阴疼痛方面的有效性。
开放标签平行组随机对照试验。
巴西圣保罗的一家助产中心。
84名需要修复一度会阴撕裂的产时妇女。
实验组（n = 42）使用Epiglu®手术胶水（乙基-2-氰基丙烯酸酯）修复会阴撕裂；对照组（n = 42）使用Vicryl Rapide®（聚乙醇酸910）缝线修复撕裂。主要结局是产后用0至10分数字疼痛评分量表测量的会阴疼痛强度。次要结局包括用“发红、水肿、瘀斑、分泌物和愈合程度”量表测量的愈合情况；用视觉模拟量表测量的妇女对会阴修复的满意度；以及完成修复所需的时间。数据收集于2020年12月至2021年5月产后住院期间及出院后10 - 20天。采用意向性分析的双变量分析和线性模型对数据进行分析。
出生后36 - 48小时，实验组会阴疼痛平均值为0.2（95%置信区间[CI] 0.1 - 0.8），对照组为0.9（95% CI 0.5 - 1.5）；实验组和对照组的会阴愈合评分分别为0.7（95% CI 0.4 - 1.2）和0.8（95% CI 0.5 - 1.2）；实验组妇女的满意度更高（88.1%对对照组的83.3%）。出院后，实验组会阴疼痛平均值为0.1（95% CI 0.0 - 0.5），对照组为1.4（95% CI 0.8 - 2.2）；实验组和对照组的会阴愈合评分分别为0.0（95% CI 0）和1.0（95% CI 0.7 - 1.3）。实验组满意度更高（94.9%对75.0%）。纵向分析显示，两组在会阴疼痛和妇女满意度方面存在统计学显著差异。实验组会阴修复平均所需时间为6.0（95% CI 4.7 - 8.7）分钟，对照组为9.7（95% CI 8.3 - 11.5）分钟（P < 0.001）。
与产后会阴缝合相比，手术胶水导致的会阴疼痛更少、修复更快且满意度更高。两种情况下的愈合过程相似。
对于一度会阴撕裂的女性，与缝合相比，手术胶水产后疼痛更小且满意度更高。
于2020年7月16日在巴西临床试验注册中心注册，注册号为RBR - 52y5tq（http://www.ensaiosclinicos.gov.br/rg/RBR - 52y5tq/）。首次招募时间为2020年12月17日。
