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Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial
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. Inter...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9055760/ https://www.ncbi.nlm.nih.gov/pubmed/35490229 http://dx.doi.org/10.1186/s12884-022-04688-x |
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author | Poskus, Tomas Sabonyte-Balsaitiene, Zivile Jakubauskiene, Lina Jakubauskas, Matas Stundiene, Ieva Barkauskaite, Gabija Smigelskaite, Mante Jasiunas, Eugenijus Ramasauskaite, Diana Strupas, Kestutis Drasutiene, Grazina |
author_facet | Poskus, Tomas Sabonyte-Balsaitiene, Zivile Jakubauskiene, Lina Jakubauskas, Matas Stundiene, Ieva Barkauskaite, Gabija Smigelskaite, Mante Jasiunas, Eugenijus Ramasauskaite, Diana Strupas, Kestutis Drasutiene, Grazina |
author_sort | Poskus, Tomas |
collection | PubMed |
description | 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12884-022-04688-x. |
format | Online Article Text |
id | pubmed-9055760 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-90557602022-05-01 Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial Poskus, Tomas Sabonyte-Balsaitiene, Zivile Jakubauskiene, Lina Jakubauskas, Matas Stundiene, Ieva Barkauskaite, Gabija Smigelskaite, Mante Jasiunas, Eugenijus Ramasauskaite, Diana Strupas, Kestutis Drasutiene, Grazina BMC Pregnancy Childbirth Research Article 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12884-022-04688-x. BioMed Central 2022-04-30 /pmc/articles/PMC9055760/ /pubmed/35490229 http://dx.doi.org/10.1186/s12884-022-04688-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Poskus, Tomas Sabonyte-Balsaitiene, Zivile Jakubauskiene, Lina Jakubauskas, Matas Stundiene, Ieva Barkauskaite, Gabija Smigelskaite, Mante Jasiunas, Eugenijus Ramasauskaite, Diana Strupas, Kestutis Drasutiene, Grazina Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial |
title | Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial |
title_full | Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial |
title_fullStr | Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial |
title_full_unstemmed | Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial |
title_short | Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial |
title_sort | preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9055760/ https://www.ncbi.nlm.nih.gov/pubmed/35490229 http://dx.doi.org/10.1186/s12884-022-04688-x |
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