Hedvig Marie Egeland Nordeng

Introduction: Recent studies have suggested selective serotonin reuptake inhibitors (SSRIs) to be implicated in bleeding related outcomes from the gastrointestinal tract (GI), however little is known about bleeding outcomes from sites other than the GI tract, especially the gynecological system. Because vaginal bleeding during early and mid pregnancy is a marker of an at-risk pregnancy, we aimed to investigate the putative association between such outcomes and exposure to SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs) during pregnancy. Methods: Three questionnaires (at gestational weeks 17 and 30, and six months after delivery) from the Norwegian Mother and Child Cohort Study (MoBa) and individual records in the Medical Birth Registry of Norway (MBRN) provided information about exposure to antidepressants, vaginal bleeding outcomes, mental health at two time points in pregnancy (gestational week 17 and 30) and maternal characteristics. Exposure was categorized according to use of SSRIs and/or SNRIs, with inclusion of a disease comparison group comprising women with persistent depressive symptoms at both gestational week 17 and 30 but not medicated. Multivariate logistic regression analysis was used to estimate the impact of exposure to antidepressants on adverse bleeding outcomes as crude and adjusted odds ratios with 95% confidence intervals. Results: The study population comprised 57,279 women. Of these, 1.0% reported use of SSRIs/SNRIs during pregnancy. Use of SSRIs/SNRIs during the first trimester was not associated with an increased risk of vaginal bleeding in early pregnancy of any kind (aOR:0.91, 95% CI:0.72-1.16), neither as trace of blood, blood loss in medium amounts or clots, nor bleeding more than once. Women in the disease comparison group were associated with a significant 32% increased risk of bleeding in medium amount or clots, 33% increased risk for recurrent bleeding episodes in early pregnancy, and bled significantly longer (in days) than the non-exposed. This very same group of women presented a moderate risk of vaginal bleeding even in mid pregnancy. Conclusions: The findings of the present study are reassuring: use of SSRIs/SNRIs during first and second trimesters is not associated with any increased risk of vaginal bleeding during pregnancy. On the contrary, women with persistent depressive symptoms during pregnancy but not medicated presented a 32-33% increased risk of vaginal blood loss in early as well as in mid pregnancy. The higher rates of vaginal bleeding among these women could be recognized as a sign of missed or threatened abortion. Nonetheless, depressed non-medicated women may present higher level of anxiety and stress, potentially leading to different health behaviors and different accuracy and attitudes in reporting.

Introduction: Few studies have been conducted comparing medication use for specific illnesses during pregnancy across different countries. The objective of this study was to investigate on an international level medication use related to maternal illness during pregnancy. Methods: An international Internet-based survey was conducted from October 2011 to February 2012 in 19 countries worldwide. Data collection was carried out for a period of two months in each participating country. Pregnant women and women who recently (within 1 year) had given birth were eligible to participate. By using an anonymous on-line questionnaire we collected information about maternal demographic and lifestyle factors, the presence of acute, chronic and pregnancy-related illnesses, and medication use during pregnancy. Results: The cumulative study population included more than 9,000 women. Preliminary results among the data collected in North America (n=516), Australia (n=207), Norway (n= 1,274) and Italy (n=931) indicate different patterns of medication use according to illness. The highest frequencies for use of medications for nausea were observed among North American (25.0%) and Australian (22.2%) women, followed by Italian (16.6%) and Norwegian (8.2%). Similarly, the highest frequencies pertaining medication use against headache were observed among the Australian (49.3%) and North American (42.6%) populations while Norwegian and Italian accounted for the lowest reporting rates (28.7% and 20.7%, respectively). Our results also indicate different patterns of medication use in relation to chronic conditions. E.g. for depression, the highest frequencies of related medication use were observed among Australian (10.6%) and North American (6.0%) women, as compared to Norwegian (1.4%) and Italian (1.2%). Conclusions: Our study indicates different patterns of medication use during pregnancy across various populations. Notably, North American and Australian pregnant women presented similar trends of medication use, with a relatively high frequency in comparison to pregnant women in European countries such as Italy and Norway.

Up to 8 out of 10 women use medications during pregnancy (1, 2). Our hypothesis is that women’s beliefs and attitudes towards medications, medication adherence, risk perception, mental health, personality traits and health illiteracy are important determinants for medication use in pregnancy. The objective of this study was to investigate medication use during pregnancy and factors related to such use across different countries. Method An international internet-based survey was conducted from October to December 2011. An anonymous on-line questionnaire was used for collecting information about maternal characteristics and life-style factors, medication use during pregnancy and timing of exposure and chronic, acute and pregnancy-related illnesses during pregnancy. Validated psychometric scales were utilised in order to measure mental health (EPDS), beliefs about medications (BMQ), medication adherence (MMAS-8), personality traits (BIG-5) and health illiteracy. A 17-items VAS scale for quantifying risk perception was also included. Results The study population included more than 7,500 pregnant women and women who recently had given birth in 19 countries worldwide. Preliminary data among the subset of data collected in Norway (n = 1,274) show that the most frequently used drug group was over-the-counter painkillers (53.3%). Over-the-counter nasal decongestants and medications for heartburn accounted for 27.3% and 26.3%, respectively. Medications for asthma have been the most widely used drug group (11.1%) among the chronic treatments, followed by medications for allergy (5.6%), hypothyroidism (1.9%) and depression (1.5%). Preliminary data from the remaining countries will also be presented. Conclusion Use of medications during pregnancy is common. It is therefore imperative to elucidate the role of various determinants of drug consumption in pregnancy on an international level. References 1. Nordeng H, Ystrøm E, Einarson A. Eur J Clin Pharmacol 2010;66:207-14. 2. Refuerzo JS, Blackwell SC, Sokol RJ, Lajeunesse L, Firchau K, Kruger M, et al. Amer J Perinatol 2005;22:321-4.

Each year approximately 60 000 infants are born in Norway. Studies conducted by the social pharmacy research group have shown that up to 80% of all pregnant women use medication during pregnancy and that 40% use herbals during pregnancy. The widespread use stands in contrast to our knowledge about the effect and safety of drugs during pregnancy. This presentation will focus on the research groups’ ongoing studies concerning the consequences of medication use for the unborn child. The studies assess associations between medication use and risk of negative pregnancy outcomes as low birth weight, spontaneous abortions, prematurity, bleeding complications and perinatal complications. Selected drug groups are antidepressants, analgesics and herbals. Data stem from the Norwegian Mother and Child Cohort Study (MoBa), the Medical Birth Registry of Norway and the Norwegian Prescription Database. The MoBa study is a population-based cohort with 100 000 children included from fetal life. Information about exposures (medication, environment etc.) and health status is collected by questionnaires completed during pregnancy. In addition, biological material from the mother, father and infant is collected. Data on pregnancy outcome come from the Medical Birth Registry. In 2004 the Norwegian Prescription Database (NoPD) was established. This database receives electronic data on all prescriptions, reimbursed and non-reimbursed, dispensed from all the five hundred Norwegian pharmacies. During the first six months of 2004 over 12 million prescriptions were recorded. The social pharmacy research group has recently conducted a linkage between the NoPD and the Medical Birth Registry. This enables new approaches for studying consequences of medication use during pregnancy.