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Randomized Controlled Trial
. 2022 Apr 30;22(1):374.
doi: 10.1186/s12884-022-04688-x.

Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial

Tomas Poskus  1 , Zivile Sabonyte-Balsaitiene  2 , Lina Jakubauskiene  2 , Matas Jakubauskas  3 , Ieva Stundiene  3 , Gabija Barkauskaite  4 , Mante Smigelskaite  4 , Eugenijus Jasiunas  5 , Diana Ramasauskaite  2 , Kestutis Strupas  3 , Grazina Drasutiene  2
Affiliations
Randomized Controlled Trial

Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial

Tomas Poskus et al. BMC Pregnancy Childbirth. .

Abstract

Background: To compare specific dietary and behavioral recommendations for hemorrhoids prevention during pregnancy.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: 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 .

Keywords: Hemorrhoids; Nutrition; Pregnancy; Prevention.

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Conflict of interest statement

This study was initiated and run by Faculty of Medicine, Vilnius University, Vilnius, Lithuania, and is a part of a Ph.D. research project of Zivile Sabonyte-Balsaitiene. The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Figures

Fig. 1
Fig. 1
Timeline of the study visits
Fig. 2
Fig. 2
CONSORT flowchart of the study
See this image and copyright information in PMC

References

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