Evidence map›Paper›PMID 35490229›Full record

Trial reportBMC pregnancy and childbirth2022

Preventing hemorrhoids during pregnancy: a multicenter, randomized clinical trial.

Tomas Poskus, Zivile Sabonyte-Balsaitiene, Lina Jakubauskiene, Matas Jakubauskas, Ieva Stundiene, Gabija Barkauskaite, Mante Smigelskaite, Eugenijus Jasiunas, Diana Ramasauskaite, Kestutis Strupas and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
7.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 34 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Tomas PoskusClinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania. tomas.poskus@santa.lt.ORCID http://orcid.org/0000-0002-6931-6041
Zivile Sabonyte-BalsaitieneClinic of Obstetrics and Gynecology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
Lina JakubauskieneClinic of Obstetrics and Gynecology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
Matas JakubauskasClinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
Ieva StundieneClinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
Gabija BarkauskaiteFaculty of Medicine, Vilnius University, Vilnius, Lithuania.
Mante SmigelskaiteFaculty of Medicine, Vilnius University, Vilnius, Lithuania.
Eugenijus JasiunasCenter of Informatics and Development, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
Diana RamasauskaiteClinic of Obstetrics and Gynecology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
Kestutis StrupasClinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
Grazina DrasutieneClinic of Obstetrics and Gynecology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
Vilnius University · LT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo compare specific dietary and behavioral recommendations for hemorrhoids prevention during pregnancy.

methodsThis 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.

resultsWe 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.

conclusionsOur 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 registrationDate 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 .

Indexed as

HemorrhoidsCounselingFemaleHumansInfant, NewbornLogistic ModelsPregnancyResearch DesignSingle-Blind MethodHemorrhoidsNutritionPregnancyPrevention

Identifiers

PMID35490229
PMCPMC9055760
OpenAlexW4225116961

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.