Clinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
Clinic of Obstetrics and Gynecology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
BMC Pregnancy Childbirth. 2022 Apr 30;22(1):374. doi: 10.1186/s12884-022-04688-x.
To compare specific dietary and behavioral recommendations for hemorrhoids prevention during pregnancy.
This was a randomized, single-blind, multicenter trial conducted in three different clinical centers. Patients were randomly allocated into two groups in a ratio of 1:1. Intervention consisted of specific dietary and behavioral counseling. The primary outcome of this study was the rate of hemorrhoids at the time of discharge from the obstetrics unit. Categorical variables were compared by the Chi-Squared or Fisher exact tests, as appropriate. Continuous variables were compared using either the Student's t-test or the Mann-Whitney U test. Binary logistic regression model was used to identify independent predictors of hemorrhoids after delivery. This analysis was performed on factors with a p-value < 0.10 in univariate analysis. Statistical analysis was performed using IBM SPSS 23.0 and GraphPad Prism 9 software. A P-value of less than 0.05 was considered significant for all tests.
We observed a significantly lower hemorrhoids rate in the intervention group at the time of discharge from the obstetrics unit after delivery (intention-to-treat (ITT) (the relative risk (RR) 0.38; 95% the confidence interval (CI) 0.24-0.59; p < 0.001) per-protocol (PP) (RR 0.42; 95% CI 0.27-0.64; p < 0.001). There was no significant difference in spontaneous miscarriage rate between the groups for both ITT and PP analysis. Additional binary logistic regression analysis revealed that the intervention applied in this study was the only protective factor. Both, the history of hemorrhoids before pregnancy and the increase of newborn height was associated with a higher risk of hemorrhoids.
Our suggested intervention, aimed to modify dietary and behavioral habits, significantly reduces the rate of hemorrhoids after pregnancy and can be safely recommended to pregnant women.
Date of registration: 2016-05-09; Date of initial patient enrollment: 2016-06-02; Trial registration number: 158200-16-843-357; Trial registration site URL: https://www.mf.vu.lt/mokslas/vilniaus-regioninis-biomedicininiu-39tyrimu-etikos-komitetas#isduoti40vrbtek-leidimai .
比较预防妊娠痔疮的特定饮食和行为建议。
这是一项在三个不同临床中心进行的随机、单盲、多中心试验。患者以 1:1 的比例随机分为两组。干预措施包括特定的饮食和行为咨询。本研究的主要结局是产妇出院时痔疮的发生率。分类变量采用卡方检验或 Fisher 确切检验进行比较，适当的。连续变量采用学生 t 检验或 Mann-Whitney U 检验进行比较。采用二元逻辑回归模型识别产后痔疮的独立预测因素。该分析针对单因素分析中 p 值<0.10 的因素进行。统计分析采用 IBM SPSS 23.0 和 GraphPad Prism 9 软件进行。所有检验的 P 值<0.05 认为差异有统计学意义。
我们观察到产后产妇出院时干预组痔疮发生率显著降低（意向治疗（ITT）（相对风险（RR）0.38；95%置信区间（CI）0.24-0.59；p<0.001）符合方案（PP）（RR 0.42；95%CI 0.27-0.64；p<0.001）。ITT 和 PP 分析两组自发性流产率无显著差异。进一步的二元逻辑回归分析显示，本研究中应用的干预措施是唯一的保护因素。妊娠前痔疮史和新生儿身高增加均与痔疮发生风险增加相关。
我们建议的干预措施旨在改变饮食和行为习惯，可显著降低妊娠后痔疮的发生率，可安全推荐给孕妇。
注册日期：2016 年 5 月 9 日；首次患者入组日期：2016 年 6 月 2 日；试验注册编号：158200-16-843-357；试验注册网址：https://www.mf.vu.lt/mokslas/vilniaus-regioninis-biomedicininiu-39tyrimu-etikos-komitetas#isduoti40vrbtek-leidimai。
