Running head: PICO: BREATHING WITH EASE IN PREGNANCY PICO: Breathing with Ease in Pregnancy: Mothers Health at the Expense of the Newborn? Julianne Shimer University of New Hampshire 1 PICO: BREATHING WITH EASE IN PREGNANCY Breathing with Ease in Pregnancy: Mothers Health at the Expense of the Newborn? Question- Do pregnant women with asthma using medications to control their symptoms have higher chances of having offspring with chronic disease, or birth defects? P: Pregnant women with asthma I: Asthma controlled with medications C: no asthma medications O: offspring with chronic diseases or birth defects Background and Rationale Asthma affects 3.7%-8.4% of all pregnancies in the United States (Cossette, 2013). It is recognized as one of the most prevalent chronic pulmonary diseases in pregnant women (Eltonsy, 2011). “A review of studies related to asthma exacerbations during pregnancy suggested that exacerbations requiring medical intervention occur in approximately 20% of women, and approximately 6% require hospital admission” (Bain, 2012, p. 1). Many women are unsure how safe asthma medications are to the health of their growing baby. However, asthma control is essential in keeping the mother healthy and well. There are risks with every medication, but looking further to see if benefits outweigh the risks is where the research needs to be explored. Recently, pregnancy specific guidelines have been made, suggesting the use of inhaled corticosteroids as well as long acting beta2 agonists, because there have been studies showing uncontrolled asthma has negative effects on the infant, such as low birth weight and preterm birth. However, there as been little research done on the effects of these drugs on the fetus (Cossette, 2013). Those suffering with asthma need to be aware 2 PICO: BREATHING WITH EASE IN PREGNANCY of the facts in order to make informed decisions about their asthma control during pregnancy in collaboration with their provider. Search Methods A search was conducted in Medline, CINHAL, and the Cochrane databases. No search engines were used. Key words used were “asthma”, “pregnancy”, and “medications”. Limits used included English language, within the last ten years, and academic journals. After including these key terms and limits, only a few relevant results were found and I removed academic journal limit and found a few other relevant and current articles. Cochrane had only one relevant systematic review, however it was only the introduction to what they would be studying over the next year or so, and had no results as of yet. This review was excluded but will be an important source to look for in the future when the review is complete; some information was used for the background of this PICO. Two articles that focused on how uncontrolled asthma effects newborns and not how medications effect the newborns were eliminated. Articles that did not include pregnant women and the use of different types of asthma control medications were eliminated. Only articles that included pregnant women, with asthma, and studied effects of asthma medications were included. A total of 8 articles were reviewed and the 3 most relevant were included. Two articles from Medline were chosen and one from CINHAL. A retrospective, 12-year cohort design study, a 10-year cohort study, and a phenomenological study of 23 women were included. Critical Appraisal of the Evidence Cossette et al., (2013) conducted a 10 year cohort study from 1998 to 2008 of pregnant women with asthma from Canada. The cohort included a total of 7376 3 PICO: BREATHING WITH EASE IN PREGNANCY pregnancies, 56.9% were using inhaled corticosteroids, and 8.8% were using just long acting beta 2 agonists. The results found that use of these types of medications showed no negative effects on perinatal outcomes, however they suggest other studies need to be done with higher doses of medications. Some strengths of the study were they broke subjects into categories of which type of medications they took and into which trimesters and how often they used them. Unfortunately only 20% of subjects had moderate to severe asthma, so many subjects rarely used their medications. Some of the women did not only have asthma, but gestational diabetes, eclampsia, and other syndromes or illnesses that may have skewed the results. The results should be viewed critically based on these weaknesses but some value can be seen as well. Those who did use their medication on a more regular basis had babies with no health problems, which is a reassuring finding. Eltonsy et al., conducted a 12-year cohort study from 1990-2002 in Canada. Women had to have at least one diagnosis of asthma, be on at least one asthma medication and be between the ages of 12-50. This study focused solely on beta2 agonists. They found the use of short acting beta2 agonist resulted in no harm to newborns, but they concluded that more research needs to be done on the use of long acting beta2 agonists (LABA) to see if congenital malformations in this study (9.5%) were due to the LABA, the severity of the asthma, or by chance. A strength of the study was they divided the women into four categories based on the frequency they used their medications. They had a large sample size of 13,117 women, however most of them used SABA, while only a small percentage used LABA. The results need to be viewed carefully due to the limited number of women actually using the LABA and the high 4 PICO: BREATHING WITH EASE IN PREGNANCY percentage of malformations. It is unclear where the birth defects originated from and leaves much room for further research. Also, the study was published in 2011, but the group looked at was from 1990-2002, meaning some participants were pregnant 23 years ago. This should be taken into consideration when reviewing the validity of this article. Lim et al., conducted a phenomenological, qualitative study. Twenty-three women were interviewed, 18 over the phone and 5 in person. The sample was purposeful in nature, recruited from an Australian hospital. Women under 18, who could not speak English and had no asthma symptoms in the last 10 years were excluded. The study asked general questions through semi structured interviews to find out about their views and worries in relation to asthma control in pregnancy, looking for themes. Some themes were risk vs. benefit, asthma as a priority, and influences of medications. The study concluded the majority of the women felt they needed more guidance and support in choosing asthma management in pregnancy. They felt there was poor communication with the health providers. Many women were unaware that their symptoms could worsen with pregnancy and how to go about handling this change. Some women were too concerned about the effects of the steroids and decided to suffer symptoms, while others felt the anxiety and symptoms were a higher risk than taking the medications. Some women, especially those having home births opted for no medication at all. The biggest weakness of the study in regard to this review was that was not done in the United States. The study did provide worthwhile results that suggest further patient teaching and increased communication with providers is necessary. Mothers need to be informed so that they are not harming their baby due to lack of knowledge on proper asthma management. Education should preferably be before they become pregnant or early in 5 PICO: BREATHING WITH EASE IN PREGNANCY pregnancy so they are aware of the changes in symptoms that may take place and have a plan. Evidence Synthesis The research shows that asthma among pregnant women is on the rise. It is a chronic disease leaving many anxious and uncertain on how to control it. Health care providers should put together clearer guidelines as well as communicate more efficiently with patients on the benefits in controlling asthma symptoms prior to pregnancy in order to alleviate the uncertainty within this population. The evidence in these articles suggest little negative effects of the medication on neonatal outcomes, yet most conclude suggesting further research is needed, due to inadequate sample size, or lower doses/usage of medications, or not enough medications included in the study. Eltonsy et al., confirmed the safety of short acting beta2 agonists, but remained unclear of the safety of long acting beta2 agonists. The research regarding asthma medications effects on neonates is limited and more focus is on the effects of uncontrolled asthma on neonates. I believe these articles do not supply enough evidence to suggest complete safety of asthma medications, but do show that management is safer than no management at all. Clinical and Research Recommendations Overall, it is clear much more extensive research must be done on the topic of asthma management in pregnancy. The most surprising result of this research was none of the relevant articles I found took place in the United States. Research needs to take place in America as well, and should include patients with higher doses of asthma medications. Participants should be purposefully selected based on degree of asthma symptoms, type and amount of medications they take, and with the greatest effort to find 6 PICO: BREATHING WITH EASE IN PREGNANCY patients with asthma as their primary diagnosis. Patients who also have other chronic diseases and medications that could potentially affect neonatal outcomes should be avoided at all costs, and excluded from the study if gestational diabetes or other syndromes or diseases arise in pregnancy. These other medications or diseases may alter the results and give skewed and unreliable data. Both quantitative and qualitative approaches should be used. Qualitative research will help delve more into mothers’ worries, and understanding their knowledge to find where the deficit lies and what clinical practice needs to improve. While quantitative helps to look at numbers, understanding doses related to neonatal outcomes, percentage of people taking certain medications, etc. Overall, more extensive research needs to take place in order to be able to recommend different asthma management strategies during pregnancy. 7 PICO: BREATHING WITH EASE IN PREGNANCY Referenced Cited Bain, E., Pierides, KL., Middleton, P., Clifton, VL., Hodyl, NA., Stark, MJ., Crowther, CA. (2012). Interventions for managing asthma in pregnancy (Protocol). The Cochrane Collaboration. (7). 1-14. Cossette, B., Forget, A., Beauchesne, M., Rey, E., Lemière, C., Larivée, P., Battista, M., Blais, L. (2013). Impact of maternal use of asthma-controller therapy on perinatal outcomes. Asthma, 68, 724-730. doi:10.1136/thoraxjnl Eltonsy, F., Forget, A., Blais, L. (2011). Beta-2 agonists use during pregnancy and the risk of congenital malformations. Birth Defects Research, (91), 937-947. Lim, A., Stewart, K., Bramson, M., Ryan, K., George, J. (2012). Asthma during pregnancy: The experiences, concerns and views of pregnant women with asthma. Informa Healthcare- Jounral of Asthma, 49(5), 474-479. doi:10.3109/02770903.2012.678024 8