Treatment of nausea in pregnancy: a cross-sectional multinational web-based study of pregnant women and new mothers.

BACKGROUND: The factors related to the treatment of nausea during pregnancy have not yet been investigated in several countries simultaneously. The present study aimed to describe differences in self-reported nausea during pregnancy and the patterns of use for both conventional and herbal medicines across countries. The factors related to nausea and its treatment and the relationships between different self-reported co-morbidities and nausea were also investigated. METHODS: This cross-sectional study used data collected by a web-based questionnaire distributed between October 2011 and February 2012 in several countries within five regions: Western, Northern, and Eastern Europe, North America, and Australia. Women who were pregnant or had a child less than one year old were eligible to participate. RESULTS: A total of 9113 women were included in the study, whereof 6701 (73.5%) had experienced nausea during pregnancy. Among respondents with nausea, conventional medicines were used by 1201 (17.9%) women and herbal medicines by 556 (8.3%) women. The extent of self-reported nausea and its treatment varied by country. Education, working status, and folic acid use were significantly associated with the use of conventional medicines against nausea. Respondents who had nausea also had a high burden of co-morbidity. CONCLUSION: The prevalence of nausea was high across all participating countries but its treatment varied, possibly due to cultural differences and differences in attitudes towards medicines. A high degree of co-morbidity was found among respondents with nausea.

Comparing pyridoxine and doxylamine succinate-pyridoxine HCl for nausea and vomiting of pregnancy: A matched, controlled cohort study.

Nausea and vomiting of pregnancy (NVP) is a common gestational condition. This is the first study to compare the use of vitamin B6 (pyridoxine) versus Diclectin (doxylamine succinate-pyridoxine HCl) for NVP symptoms. Participants were pregnant women with NVP who used either pyridoxine or doxylamine succinate-pyridoxine HCl for ≥4 days prior to calling the Motherisk NVP Helpline. Women receiving pyridoxine only (n = 80) were matched to a woman taking doxylamine succinate-pyridoxine HCl only (n = 80), accounting for potential confounders and baseline level of NVP, measured by the Pregnancy Unique Quantification of Emesis (PUQE) score. Change in NVP severity after a week of therapy with either pyridoxine or doxylamine succinate-pyridoxine HCl was quantified using the PUQE-24 scale, which describes NVP symptoms 24 hours prior to their call. Doxylamine succinate-pyridoxine HCl use found a significant reduction in PUQE score, compared with pyridoxine (+0.5 versus -0.2, P < .05; negative denotes worsening). This association was especially prominent in women with more severe symptoms, where doxylamine succinate-pyridoxine HCl use saw a mean improvement of 2.6 versus 0.4 with pyridoxine (P < .05). As well, doxylamine succinate-pyridoxine HCl use was associated with fewer women experiencing moderate to severe scores after a week of treatment, compared with the pyridoxine group (7 versus 17, P < .05), despite similar baseline PUQE scores.

The protective effects of nausea and vomiting of pregnancy against adverse fetal outcome--a systematic review.

UNLABELLED: Studies have suggested that nausea and vomiting of pregnancy (NVP) may confer favorable pregnancy outcome, when compared to women not experiencing NVP. However, this was never examined systematically. METHODS: We systematically reviewed all human studies examining potential effects of NVP on rates of miscarriage, intrauterine growth restriction, congenital malformations, prematurity and developmental achievements. RESULTS: Our analysis reveals a consistent favorable effect of NVP on rates of miscarriages, congenital malformations, prematurity, and developmental achievements. The effect size was clinically important for miscarriage, malformations and prematurity. In a few studies the protective effects were more prominent in women with moderate-severe NVP than among those with mild or no NVP. CONCLUSIONS: NVP is associated with favorable fetal outcome, and therefore studies of drug exposure in pregnancy should either match their exposed and control cases for existence and severity of NVP, or adjust for these confounders in their multivariate analysis.

Bias against the null hypothesis: scaring pregnant women about drugs in pregnancy.

QUESTION: Since the thalidomide disaster, medicine is practised as if every drug is teratogenic, when in fact very few medications are. Pregnant women are often ready to refuse treatment even for life-threatening conditions owing to misinformation and misperceptions about fetal risks. How can I reassure my patients and prevent misinformation from affecting their treatment? ANSWER: Physicians must provide evidence-based counseling to their patients. For example, antihistamines for morning sickness have been proven safe in numerous studies, but are commonly the subject of media reports overstating the risks to the fetus. Family physicians and obstetricians must take an active role in preventing pregnant patients from being misinformed.

The delayed-release combination of doxylamine and pyridoxine (Diclegis®/Diclectin ®) for the treatment of nausea and vomiting of pregnancy.

Nausea and vomiting of pregnancy (NVP) affects up to 85 % of all pregnancies. Effective treatment can greatly improve a woman's quality of life, reduce the risk for maternal and fetal complications, and reduce healthcare costs. Unfortunately, many women receive either no pharmacological treatment or are recommended therapies for which fetal safety and efficacy have not been established. First-line treatment of NVP, as recommended by several leading healthcare and professional organizations, is the combination of doxylamine and pyridoxine. This combination, formulated as a 10 mg/10 mg delayed-release tablet, was approved by the US Food and Drug Administration (FDA) for the treatment of NVP in April 2013 under the brand name Diclegis(®), and has been on the Canadian market since 1979, currently under the brand name Diclectin(®). The efficacy of Diclegis(®)/Diclectin(®) has been demonstrated in several clinical trials, and, more importantly, studies on more than 200,000 women exposed to doxylamine and pyridoxine in the first trimester of pregnancy have demonstrated no increased fetal risk for congenital malformations and other adverse pregnancy outcomes. The present review aims to present the scientific evidence on the effectiveness and fetal safety of Diclegis(®)/Diclectin(®) for the treatment of NVP to justify its use as first-line treatment for NVP.

Surviving morning sickness successfully: from patient's perception to rational management.

Nausea and vomiting of pregnancy (NVP) affects up to 85% of pregnant women, with varying degrees of severity. The most severe form of NVP, known as hyperemesis gravidarum (HG), affects up to 2% of pregnancies. Women who have suffered with severe NVP/HG in a previous pregnancy have a 75-85% recurrence rate. Both patients and physicians often fear the use of pharmacological therapies during pregnancy due to the concerns of potential risks to the fetus. The symptoms and impact of NVP and HG can vary greatly among women, therefore treatment must be tailored to the individual. Updated Motherisk guidelines are presented.

The management of nausea and vomiting of pregnancy and hyperemesis gravidarum--a 2013 update.

Nausea and vomiting of pregnancy (NVP) affects up to 85% of all pregnancies, yet many physicians are uncertain as to how to best treat their patients in the presence of controversial data on fetal risks. This review provides an update on the management of NVP, including pharmacological and non pharmacological approaches Due to a high rate of recurrent symptoms, it is important for women to receive early treatment to reduce the severity of symptoms with the aim of preventing hospitalization and improving quality of life.

The Leading Concerns of American Women with Nausea and Vomiting of Pregnancy Calling Motherisk NVP Helpline.

Background. Nausea and vomiting of pregnancy (NVP) is the most common medical condition of pregnancy, affecting up to 85% of expecting mothers. In the USA, there is no FDA-approved medication for the treatment of NVP. Objective. To identify the primary concerns of American women leading them to contact the Motherisk NVP Helpline and to characterize the severity of their symptoms and therapy offered in order to develop improved and customized counseling for them. Methods. We reviewed the intake forms of the American women who called the NVP Helpline from 2008 to 2012. We extracted their state of residence, demographic data, severity of NVP symptoms, and other available clinical characteristics. Results. A total of 195 forms were reviewed. Of these, 86% called for information on management of NVP with/without questions about fetal drug safety, while 14% called solely about drug safety during pregnancy/breastfeeding. The majority of women were Caucasian, in their thirties, educated, employed, married and in their second pregnancy. Of them 95% were suffering from moderate-to-severe condition with 13% having hyperemesis gravidarum. Conclusion. American women need more information on the management of NVP and on a variety of its aspects in addition to the safety and effectiveness of antiemetic medications. Their leading concern was the use of doxylamine and vitamin B6 combination for NVP treatment followed by the use of ondansetron.

Preemptive treatment of nausea and vomiting of pregnancy: results of a randomized controlled trial.

Objectives. To determine whether the initiation of treatment (preemptive treatment) before the symptoms of nausea and vomiting of pregnancy (NVP) versus when the symptoms begin can improve the outcome in patients at a high risk for recurrence of severe NVP. Study Design. Prospective, randomized controlled trial. Results. Preemptive therapy conferred a significant reduction in HG as compared to the previous pregnancy (P = 0.047). In the preemptive arm, there were 2.5-fold fewer cases of moderate-severe cases of NVP than those in the control group (15.4% versus 39.13%) in the first 3 weeks of NVP (P = 0.05). In the preemptive group, significantly more women had their NVP resolved before giving birth (78.2% versus 50%) (P < 0.002). Conclusions. Preemptive treatment with antiemetics is superior to the treatment that starts only when the symptoms have already occurred in decreasing the risk of severe forms of NVP.

Therapeutic choices for nausea and vomiting of pregnancy: a critical review of a systematic review.

With 80% of pregnant women suffering from some degree of "morning sickness," or nausea and vomiting of pregnancy (NVP), symptom management is a major challenge. A recent Cochrane systematic review of randomized controlled trials concluded that, to date, there is no strong evidence of effectiveness for practically any therapeutic agent used for management of NVP. Because of fears of teratogenicity and litigation, RCTs are rarely conducted in pregnancy. In the absence of the best possible evidence from RCTs, well planned and executed prospective observational studies should be used as the best available evidence to guide clinical practice.

Optimal management of nausea and vomiting of pregnancy.

Nausea and vomiting of pregnancy (NVP) is a common medical condition in pregnancy with significant physical and psychological morbidity. Up to 90% of women will suffer from NVP symptoms in the first trimester of pregnancy with up to 2% developing hyperemesis gravidarum which is NVP at its worst, leading to hospitalization and even death in extreme cases. Optimal management of NVP begins with nonpharmacological approaches, use of ginger, acupressure, vitamin B6, and dietary adjustments. The positive impact of these noninvasive, inexpensive and safe methods has been demonstrated. Pharmacological treatments are available with varying effectiveness; however, the only drug marketed specifically for the treatment of NVP in pregnancy is Diclectin(®) (vitamin B6 and doxylamine). In addition, the Motherisk algorithm provides a guideline for use of safe and effective drugs for the treatment of NVP. Optimal medical management of symptoms will ensure the mental and physical wellbeing of expecting mothers and their developing babies during this often stressful and difficult time period. Dismissing NVP as an inconsequential part of pregnancy can have serious ramifications for both mother and baby.

Nausea and vomiting in pregnancy is not always nausea and vomiting of pregnancy.

The majority of pregnant women experience nausea and vomiting during pregnancy. However, nausea and vomiting in pregnancy is not always nausea and vomiting of pregnancy (NVP). The differential diagnosis of nausea and vomiting in pregnancy can be extensive and the underlying cause can sometimes be difficult to diagnose. However, the timing or onset of the symptoms is important in differentiating NVP from other causes. A thorough history and physical examination, with appropriate investigations, should be carried out in symptomatic women.

Treatment of heartburn and acid reflux associated with nausea and vomiting during pregnancy.

QUESTION: In addition to suffering from nausea and vomiting of pregnancy, which is being treated with antiemetics, some of my pregnant patients complain of heartburn and acid reflux. Should these symptoms also be treated and, if so, which acid-reducing medications are safe for use during pregnancy? ANSWER: Increased severity of nausea and vomiting of pregnancy is associated with the presence of heartburn and acid reflux. Antacids, histamine-2 receptor antagonists, and proton pump inhibitors can be used safely during pregnancy, as large studies have been published with no evidence of adverse fetal effects.

The effect of Acid-reducing pharmacotherapy on the severity of nausea and vomiting of pregnancy.

Background. Heartburn and acid reflux (HB/RF) are associated with increased severity of nausea and vomiting. The ability of acid-reducing drugs to reduce symptoms of nausea and vomiting of pregnancy has not been previously tested. Objective. To determine whether acid-reducing pharmacotherapy decreases the severity of NVP symptoms. Methods. We studied a cohort of women experiencing NVP, who were also experiencing HB/RF. Women were counseled to commence acid-reducing pharmacotherapy. The effectiveness of the acid-reducing medication in decreasing symptoms of both HB/RF and NVP was measured. Results. Acid-reducing drugs resulted in significant decreases in PUQE (9.6 +/- 3.0 to 6.5 +/- 2.5, P < .0001) and well-being scores from the initial (4.0 +/- 2.0) to the follow-up interview (6.8 +/- 1.6, P < .0001). After intervention with acid-reducing pharmacotherapy, a reduction in acid symptoms correlated significantly with reduction in NVP (R(2) = 0.72, P < .001). Conclusion. This is the first study to demonstrate that management of HB/RF can reduce the severity of NVP.

Nausea and vomiting of pregnancy: using the 24-hour Pregnancy-Unique Quantification of Emesis (PUQE-24) scale.

With up to 80% of pregnant women experiencing nausea and vomiting of pregnancy (NVP), it is critical to have a graded scale of its severity as a guide for appropriate treatment. In 2002 we introduced the Pregnancy-Unique Quantification of Emesis (PUQE) scoring system, which assessed the severity of nausea and vomiting in pregnancy (NVP) based on three physical symptoms: nausea, vomiting, and retching over the previous 12 hours. We present here validation of an extension of the original PUQE, by assessing NVP over 24 hours. This extension is deemed more clinically relevant, because assessment of symptoms over only 12 hours may encompass sleeping hours and hence may not adequately capture the length and severity of the symptoms. In this study we assessed the external validity of the new PUQE-24 by examining its ability to evaluate several characteristics associated with NVP: (a) ability to take multivitamin supplements; (b) rates of hospitalization and emergency room visits for severe symptoms; (c) sleep patterns; (d) liquid intake; and (e) the woman's self-rated well-being scores. Data collected prospectively from 315 women counselled via the Motherisk NVP line were used for the validation. PUQE-24 showed strong correlation with all parameters examined except for sleep patterns and hydration status. The well-being score, however, correlated significantly with hydration status. Capturing 24 hours rather than 12 hours of symptoms may better direct management of NVP and predict its outcome.

The effect of heartburn and acid reflux on the severity of nausea and vomiting of pregnancy.

BACKGROUND: Heartburn (HB) and acid reflux (RF) in the nonpregnant population can cause nausea and vomiting; therefore, it is plausible that in women with nausea and vomiting of pregnancy (NVP), HB/RF may increase the severity of symptoms. OBJECTIVE: To determine whether HB/RF during pregnancy contribute to increased severity of NVP. METHODS: A prospectively collected cohort of women who were experiencing NVP and HB, RF or both (n=194) was studied. The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) scale and its Well-being scale was used to compare the severity of the study cohort's symptoms. This cohort was compared with a group of women experiencing NVP but no HB/RF (n=188). Multiple linear regression was used to control for the effects of confounding factors. RESULTS: Women with HB/RF reported higher PUQE scores (9.6+/-2.6) compared with controls (8.9+/-2.6) (P=0.02). Similarly, Well-being scores for women experiencing HB/RF were lower (4.3+/-2.1) compared with controls (4.9+/-2.0) (P=0.01). Multiple linear regression analysis demonstrated that increased PUQE scores (P=0.003) and decreased Well-being scores (P=0.005) were due to the presence of HB/RF as opposed to confounding factors such as pre-existing gastrointestinal conditions/symptoms, hyperemesis gravidarum in previous pregnancies and comorbidities. CONCLUSION: The present cohort study is the first to demonstrate that HB/RF are associated with increased severity of NVP. Managing HB/RF may improve the severity of NVP.

Treatment of nausea and vomiting in pregnancy: an updated algorithm.

QUESTIONMy patient has severe nausea and vomiting of pregnancy (NVP). I am having difficulty treating her, as nothing she has tried so far has been really effective. I heard that there is some new information regarding the treatment of this condition.ANSWEREven a less severe case of NVP can have serious adverse effects on the quality of a woman's life, affecting her occupational, social, and domestic functioning, and her general well-being; therefore, it is very important to treat this condition appropriately and effectively. There are safe and effective treatments available. We have updated Motherisk's NVP algorithm to include recent relevant published data, and we describe some other strategies that deal with secondary symptoms related to NVP.