Possible association of maternal haemorrhoid with congenital abnormalities in their children – a population-based case-control study
Ferenc Bánhidy, M.D.1, Nándor Ács, M.D.1, Erzsébet H. Puhó2, and Andrew E. Czeizel2*
*Corresponding Author: Andrew E. Czeizel, Foundation for the Community Control of Hereditary Diseases, 1026 Budapest, Törökvész lejtõ 32. Hungary; Tel: +36 1 3944 712, Fax: +36 1 3944 712; E-mail: czeizel@interware.hu
page: 25

Exposure Data and Possible Confounders

1. Prospective data recorded by medical doctors. Mothers were asked, in an explanatory letter, to send us the prenatal maternity logbook and other medical records particularly discharge summaries. Since prenatal care was mandatory and non-attendance carried serious penalty, nearly 100% of pregnant women visited prenatal care clinics, on average 7 times. The first visit was between the 6th and 12th gestational week when obstetricians recorded all pregnancy complications, maternal diseases and related drug prescriptions in the prenatal maternity logbook. 2. Retrospective self-reported maternal information. A structured questionnaire, a list of drugs and vitamin supplements, a list of diseases, and a printed informed consent form for signature were also mailed to the mothers immediately after the selection of cases and controls. The list of diseases (including haemorrhoid) and of drugs/supplements that were enclosed was used as a memory aid before the questionnaire was filled in. The mean + S.D. time elapsed between the birth or pregnancy termination and the return of the “information package” (questionnaire, logbook, etc) in the prepaid envelope was 3.5 + 1.2 and 5.2 + 2.9 months in the case and control groups, respectively 3. Supplementary data collection. Regional nurses were asked to visit all non-respondent case mothers at home and to help them filling in the questionnaire, to evaluate available medical records, particularly prenatal maternity logbook**. In addition they were asked to obtain data of lifestyle factors through an interview of mothers and fathers or other close relative living with them so that a ‘family consensus’ was recorded regarding smoking and alcohol drinking. Smoking was recorded as the number of cigarettes per day. Drinking was recorded as (i) abstinent or occasional (less than one drink per week), (ii) regular (from one drink daily to one drink per week), and (iii) hard (more than one drink per day). Regional nurses visited 200 non-respondent and 600 respondent control mothers in two validation studies [8, 9] because the committee on ethics considered this follow-up to be disturbing if required for the parents of all the healthy children. Similar methods were used for control and for case mothers. The exposure data were available on 96.3% of cases (84.4% from reply to the mailing, 11.9% from the nurse visit) and 83.0% of the controls (81.3% from reply, 1.7% from visit). Informed consent form was obtained from 98% of mothers. The preliminary analysis revealed one group of pregnant women who had medically-recorded diagnosis of haemorrhoid in the prenatal maternity logbook that was confirmed by the obstetrical examination and a second group who had reported haemorrhoid in the questionnaire by mothers, but that was not recorded in the prenatal maternity logbook usually because there was no treatment and/or their onset was not reported. The second group was not included in the study. All drug treatments, medically-recorded or self-reported, were evaluated with special attention to those that were haemorrhoid related. Potential confounding factors such as maternal age, birth order, marital and employment status as indicators of socio-economic status [10], pregnancy complications, other maternal diseases, vitamin supplements particularly folic acid and multivitamins as indicators of the standard of preconceptional and prenatal care, were also considered. Gestational time was calculated from the first day of the last menstrual period. Since the critical period of most major CAs is in the second and third gestational months, this time window was used in the study [11]. Besides birth weight (g) and gestational age at delivery (wk), the frequency of low birth weight (< 2500 g) and preterm births (< 37 weeks) as adverse birth outcomes were analyzed on the basis of discharge summaries from inpatient obstetric clinics. Statistical Methods SAS version 8.02 (SAS Institute Ins., Cary, North Carolina, USA) was used for statistical analyses. First the main maternal and newborn variables were evaluated in case and control pregnant women with or without haemorrhoid as reference using Student t test for quantitative chi square test for categorical variables. The occurrence of pregnancy complications, other maternal diseases and drug intakes during pregnancy, were compared between the case and the control mothers with haemorrhoid using crude odds ratios (OR) with 95% confidence intervals (CI). The occurrence of haemorrhoid in the mothers of cases with specific CA groups and in the mothers of all matched controls WAS compared in conditional logistic regression models and adjusted OR with 95% CI WAS calculated for estimating of association of maternal haemorrhoid with CA in their children. The bias connected with multiple testing was limited by the use of the Bonferroni method [12].



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