Breastfeeding women in need of information about antiemetics for nausea and vomiting during pregnancy: a review of inquiries to a medicines information service.

Introduction: The medicines information service, SafeMotherMedicine, regularly receives inquiries from breastfeeding women asking about antiemetics for nausea and vomiting during pregnancy (NVP) or hyperemesis gravidarum (HG). However, treatment guidelines for NVP or HG do not address the use of antiemetics in women who are breastfeeding while becoming pregnant again. Our objective was to characterize inquiries to describe the need for lactation risk information among women with NVP or HG and also to raise awareness of this topic. Method: We conducted a review of inquiries to the Norwegian web-based medicines information service, SafeMotherMedicine. Results: In total, 97 inquiries addressing the use of antiemetics for NVP or HG during breastfeeding were identified. The following medications were addressed in the inquiries (n = 97): meclizine (51%), metoclopramide (33%), promethazine (16%), ondansetron (9%), and others (6%). The breastfed child was older than 6 months and 1 year in 96% and 71% of the inquiries, respectively. There was a preponderance of general inquiries (unclear motivation/double checking) (64%); however, one-third of the inquiries were generated by restrictive information from sources such as product information. Conclusion: Based on our small review of spontaneous inquiries, there seems to be an information need about the use of antiemetics during lactation among women breastfeeding an older infant whilst suffering from NVP or HG. Addressing such use in guidelines for NVP and HG and/or other easily available information sources may be considered in order to balance out the restrictive information provided by the manufacturers. This could avoid potential unnecessary weaning of breastfeeding in an otherwise challenging situation.

Healthcare professionals' information need related to antiseizure medication use in breastfeeding patients with epilepsy. Retrospective analysis of enquiries to Norwegian medicines information and pharmacovigilance centers.

Background: Safety information of antiseizure medication (ASM) during breastfeeding is scarce and conflicting. We aimed to identify characteristic traits of safety concerns among healthcare professionals by reviewing enquiries to the Norwegian Regional Medicines Information and Pharmacovigilance Centres (RELIS). Method: Enquiries related to breastfeeding, epilepsy, and ASM identified by their ATC-numbers were retrieved from the RELIS database of question-and-answer pairs (QAPs) by combining indexed and Boolean database searches and manual inspection. 112 QAPs were analyzed retrospectively using descriptive statistics. Results: Hospital-employed physicians and nurses were puzzled by ambiguous or conflicting drug information advice and called for general information about the compatibility of an ASM with breastfeeding, mainly related to lamotrigine and levetiracetam. Other enquiries were related to co-medication with other drugs, mainly antidepressants. Half of the enquiries were posed after birth, 12 of these motivated by suspected adverse events in the infants. Conclusion: Healthcare professionals with acknowledged high competence in the topic were uncertain about the prevailing safety information of ASM during breastfeeding. The fear to harm the infant may lead to the decision not to recommend breastfeeding. Future information strategies should aim to reach these professions, and support their information need on this topic.

Identifying target areas of medicines information efforts to pregnant and breastfeeding women by reviewing questions to SafeMotherMedicine: A Norwegian web-based public medicines information service.

BACKGROUND: Online information about safety of medications during pregnancy and breastfeeding is shown to be conflicting, resulting in anxiety and abstaining from use. The aim of this study was to characterize questions to SafeMotherMedicine, a web-based medicines information service for pregnant and breastfeeding women, to identify target areas that could guide subsequent development of medicines information directed at pregnant and breastfeeding women. METHODS: The SafeMotherMedicine database contains all questions received through the web-based service and their corresponding answers. A retrospective database analysis of questions received from January 2016 to September 2018 was performed, using descriptive statistics. RESULTS: A total of 11 618 questions were received including 5 985 questions (51.5%) concerning pregnancy, 4 878 questions (42.0%) concerning breastfeeding, and 755 questions (6.5%) concerning both conditions. The medications in question represented all therapeutic groups with paracetamol (7.0%), ibuprofen (4.1%), cetirizine (3.3%), desloratadine (3.2%) and meclizine (2.8%) being the top five. The 20 medications most frequently asked about for either pregnancy, breastfeeding or both pregnancy and breastfeeding, constituted half of all questions and were used to identify target areas. These included both symptomatic relief of common complaints, such as pain, nausea, and rhinitis, as well as treatment of chronic conditions such as allergy, psychiatric disorders, and asthma. Analysis of a subset of questions showed that most of these questions were asked before use of medications in a current pregnancy (49%) or during breastfeeding (72%). The questions concerned use of medications in all stages of pregnancy and breastfeeding. For 81.6% of the questions concerning pregnancy, and for 84.2% of the questions concerning breastfeeding, information of no or low risk for the foetus or the breastfed infant was provided by SafeMotherMedicine. CONCLUSIONS: We found that target areas for medicines information directed at pregnant and breastfeeding women included both symptomatic relief of common complaints as well as treatment of chronic conditions. The questions concerned a wide range of medications and involved use in all stages of pregnancy and breastfeeding. Our findings indicate that developing medicines information addressing the identified target areas will meet the information need for a large proportion of this patient group.

Perceived risk of neurodevelopmental outcomes in offspring related to psychotropic and mental illness exposures in pregnancy and breastfeeding: a cross-sectional survey of women with past or current mental illness.

OBJECTIVES: To investigate the perceived risk of psychotropic and mental illness exposures (1) during pregnancy or (2) while breastfeeding on offspring neurodevelopment, and factors associated with this perception in women with past/current mental illness. DESIGN: Cross-sectional, web-based study. SETTING: Nationwide in Norway, June 2020-June 2021. PARTICIPANTS: Women aged 18-55 years who were pregnant, recent mothers or planning a pregnancy, and had been offered antidepressants in the last 5 years. PRIMARY AND SECONDARY OUTCOME MEASURES: Perceived risk of prenatal and breastmilk exposure to psychotropic medications and maternal mental illness on offspring neurodevelopmental outcomes. RESULTS: We included 448 women: 234 pregnant, 146 mothers and 68 planning a pregnancy. On a 0-10 scale, women perceived antidepressants as least harmful both (1) in pregnancy (mean score 4.2, 95% CI 3.6 to 4.8) and (2) while breastfeeding (mean score 3.8, 95% CI 3.3 to 4.4), relative to antipsychotics, anxiety/sleeping medication or antiepileptics (mean score range: 6.3-6.5 during pregnancy, 5.5-6.2 while breastfeeding). Many participants were unfamiliar with psychotropics other than antidepressants. The perceived risk of mental illness exposure exceeded that of antidepressants (mean score range 5.6-5.9) in both exposure periods. Using general linear models, factors associated with greater antidepressant risk perception in both exposure periods included having lower education, non-Norwegian native language, and employment status (range mean score difference (ß): 2.07-6.07). For pregnant women and mothers, there was an inverse association between perceived risk and the perceived antidepressant effectiveness in both exposure periods (range of ß: -0.18 to -0.25). CONCLUSIONS: In women with past/current mental illness, the perceived risk of antidepressant exposure on child neurodevelopment was lower than that for maternal mental illness. Other psychotropic medications were perceived as more harmful. As medication risk perception influences the decision-making regarding treatment of mental illness, pre- and pregnancy counselling should target women with characteristics associated with higher perceived risk.

Antiemetic treatment of hyperemesis gravidarum in 1,064 Norwegian women and the impact of European warning on metoclopramide: a retrospective cohort study 2002-2019.

BACKGROUND: Women suffering from severe nausea and vomiting during pregnancy, hyperemesis gravidarum, have poor quality of life and increased risk of potentially fatal maternal and fetal complications. There is increasing and reassuring knowledge about safety of antiemetics in pregnancy. In 2013, the European Medical Agency (EMA) issued a warning on metoclopramide limiting treatment to maximum five days. Metoclopramide was the most used antiemetic in pregnancy at the time the warning was implemented in the Norwegian hyperemesis guidelines (2014). We aimed at describing changes in the treatment of hyperemesis over time, including changes associated with the EMA warning. METHODS: Retrospective chart review of all women hospitalized for hyperemesis gravidarum with metabolic disturbances between 01/Jan/2002 and 31/Dec/2019 at a university hospital serving nearly 10% of the pregnant population in Norway. Time-series analysis described changes over time and interrupted time series analysis quantified changes in treatment and clinical outcomes related to the EMA warning. RESULTS: In total, 1,064 women (1.2% of the birthing population) were included. The use of meclizine, prochlorperazine, and ondansetron increased during 2002-2019. This led to a yearly increase in the percentage of women using any antiemetic of 1.5% (95%CI 0.6; 2.4) pre-hospital, 0.6% (95%CI 0.2; 1.1) during hospitalization, and 2.6% (95%CI 1.3; 3.8) at discharge. Overall, only 50% of the women received antiemetics pre-hospital. Following the EMA warning, prehospital use of metoclopramide dropped by 30% (95%CI 25; 36), while use of any antiemetic pre-hospital dropped by 20% (95%CI 5.7; 34). In timely association, we observed a decrease in gestational age (-3.8 days, 98.75%CI 0.6; 7.1) at first admission, as well as indication of increased rate of termination of pregnancy with an absolute increase of 4.8% (98.75%CI 0.9; 8.7) in 2014. CONCLUSION: During 2002-2019, the overall use of antiemetics in treatment of hyperemesis increased. The EMA-warning on metoclopramide in 2013 temporarily limited pre-hospital antiemetic provision associated with hospitalization at lower gestational length and indication of an increase in termination of pregnancy.

SafeMotherMedicine: Aiming to Increase Women's Empowerment in Use of Medications During Pregnancy and Breastfeeding.

PURPOSE: Approximately 80% of pregnant women use medications. There is a need for evidence based medicines information that provide realistic risk estimates as pregnant and breastfeeding women tend to overestimate the risk of medications. The purpose of this paper is to describe the development and future perspectives of an innovative medicines information service aiming to increase empowerment among pregnant and breastfeeding women. DESCRIPTION: SafeMotherMedicine (SMM) (www.tryggmammamedisin.no) is a Norwegian medicines information service for pregnant and breastfeeding women. Established in 2011, the service was initially web-based only, in contrast to most teratology information services that at the time mainly operated using telephone and/or e-mail. ASSESSMENT: During the last eight years, SMM has provided close to 30,000 answers promoting appropriate medication use among pregnant and breastfeeding women. SMM launched a telephone-service in 2016, however, the annual number of questions received through the web-based service continues to increase. CONCLUSION: The service seems to have fulfilled a previously unmet need of evidence-based, individually tailored information about medications to pregnant and breastfeeding women in Norway. SMM empowers the women to make informed decisions regarding medication use in pregnancy and breastfeeding, thus contributing to person-centred medicine. The web-based design of the service may represent the pregnant and breastfeeding women's preferred way of communication.

Review of Questions Concerning Clinical Drug Interactions in ADHD Treatment From Physicians in Norway.

Pharmacological treatment of attention deficit hyperactivity disorder (ADHD) is challenging due to a wide age span among patients, risk of reduced adherence, and comorbidities like psychiatric disorders and drug addiction. Drugs used for ADHD are associated with risk of interactions and adverse drug reactions due to their potent pharmacological effect. In this brief report we aimed to describe real-world problem areas concerning interactions in pharmacotherapy of ADHD. We reviewed questions to a Norwegian drug information center from physicians concerning drug-drug interactions involving ADHD drugs in the last 10-year period. Questions were retrieved by a combination of indexed and Boolean database searches, in addition to manual inspection. ADHD drugs and interacting drugs were defined according to the Anatomical Therapeutic Chemical (ATC) classification system. Interactions were classified by use of Stockley's Interactions Checker (SIC). Answers were examined with regard to whether the advice from the drug information center was more restrictive, similar or more liberal than SIC when assessing drug combinations. We retrieved 61 questions that included assessment of 96 drug combinations, and found 33 potential interactions according to SIC. Methylphenidate was involved in more than 50% of the interactions, and interacting drugs were in nearly 70% of the cases from ATC-group N (Nervous system) with antidepressants most frequently involved. Seventy percent of the interactions were pharmacodynamic, and interactions were frequently described as potentially severe although they were based on theoretical evidence. All the 33 interactions could be handled with monitoring or adjusting dose or with informative measures, and none was contraindicated according to SIC. More than 90% of the questions came from physicians in hospitals or outpatient specialist practice, and questions mainly concerned adults. In 75% of the drug combinations that involved ADHD drugs, we found similar advice from SIC and the drug information center. Our results suggest that future drug information efforts in ADHD treatment to clinicians, including specialists in the field, should focus on psychotropic interactions.

Women's perspectives on the management and consequences of hyperemesis gravidarum - a descriptive interview study.

OBJECTIVE: Hyperemesis gravidarum (HG) affects 0.3-3% of pregnant women and is a leading cause of hospitalization in early pregnancy. The aim of the study was to investigate women's treatment and management of HG, as well as the consequences of HG on women's daily life. DESIGN AND SETTING: A cross-sectional study based on a structured telephone interview and an online questionnaire. Participants were recruited by social media and by the Norwegian patient's organization for HG. SUBJECTS: Norwegian women that experienced HG. MAIN OUTCOME MEASURE: Women's perspectives on management and consequences of HG. RESULTS: The study included 107 women. Maternal morbidity was profound; about 3/4 of participants were hospitalized due to HG, and the majority showed clinical signs of dehydration (79%), ketonuria (75%), and >5% weight loss (84%). Antiemetics were used by >90% and frequently prescribed "as needed". Metoclopramide (71%) and meclozine (51%) were most commonly used. Participants described HG as having severe psychosocial consequences and profound impact on daily activities. Almost two out of five reported thoughts of elective abortion, and 8 women had at least one elective pregnancy termination due to HG. Overall, 20 women (19%) changed GPs due to dissatisfaction with HG management. CONCLUSION: Despite the high psychosocial burden and major impact on daily activities, many women with HG reported a lack of support from healthcare professionals and suboptimal management. Greater awareness and knowledge among healthcare professionals is needed to improve care for women with HG. Key Points There is a paucity of studies on management and the consequences of HG on women's daily lives and psychosocial burden. We found that: • Many women described HG as one of their worst life experiences with profound morbidity. • Many women reported suboptimal management of HG and lack of support from healthcare professionals. • Greater understanding of patient perspectives among healthcare professionals is important to improve care and management for HG patients.

The burden of nausea and vomiting during pregnancy: severe impacts on quality of life, daily life functioning and willingness to become pregnant again - results from a cross-sectional study.

BACKGROUND: Though nausea and vomiting is very common during pregnancy, no studies have investigated the impact of this condition on the women's daily lives in a Scandinavian population. The aim of this study was to describe the burden of nausea and vomiting during pregnancy (NVP) on global quality of life, daily life functioning and willingness to become pregnant again according to the severity of NVP symptoms. METHODS: This study is a cross-sectional population-based study conducted in Norway. Pregnant women and mothers with children <1 year of age with current or prior NVP were eligible to participate. Data were collected through an anonymous on-line questionnaire accessible from November 10th, 2014 to January 31st, 2015. Severity of NVP was measured using the 24-h Pregnancy Unique Quantification of Emesis Scale (PUQE). Associations between severity of NVP, daily life functioning and willingness to become pregnant again were tested using chi-square tests. Associations with global quality of life measured in terms of the Quality of Life Scale (QOLS) were estimated using generalized linear models and reported as unstandardized regression coefficients (ß) with 95% confidence intervals (CI). RESULTS: 712 women with NVP were included in the study. NVP was significantly associated with several characteristics, including daily life functioning, quality of life and willingness to become pregnant again. The negative impact was greater the more severe the symptoms were, although considerable adverse effects were also seen among women with mild and moderate NVP symptoms. Over one fourth of the women with severe NVP considered terminating the pregnancy due to NVP, and three in four considered not to get pregnant again. Severity of NVP remained significantly associated with reduced global quality of life when adjusting for maternal characteristics and illnesses with ß (95% CI) = -10.9 (-16.9, -4.9) for severe versus mild NVP. CONCLUSIONS: NVP as measured by PUQE had a major impact on various aspects of the women's lives, including global quality of life and willingness to become pregnant again.

Pharmacists counselling of pregnant women: Web-based, comparative study between Serbia and Norway.

OBJECTIVES: To describe, compare and evaluate whether pharmacists in two European countries, Serbia and Norway, give appropriate counselling for common ailments in pregnancy. DESIGN: A cross sectional, web-based study. PARTICIPANTS AND SETTINGS: A study was conducted among Serbian and Norwegian pharmacists during two four-month study periods in 2012 respectively 2014. Participants were recruited through postal and electronic invitation facilitated by several pharmacy chains. Participation in the study was anonymous and voluntary. MEASUREMENT INSTRUMENT: Pharmacists were presented with the questionnaire that included five scenarios (back pain, heavy legs, nausea, cold and constipation in pregnancy) and were asked to give their advice about use of medicines, supplements (e.g. herbal products, vitamins, minerals), non-pharmacological treatment and referral to physician in each condition. FINDINGS: In total, 276 pharmacists, 119 in Serbia and 157 in Norway, accepted to participate in the study. Recommendation about medicines use ranged from 32% (heavy legs) to 71% (back pain) in Serbia and from 3% (heavy legs) to 92% (constipation) in Norway. Several pharmacists' recommendations on medicines and supplements use were inappropriate. Recommendation about non-pharmacological treatments ranged from 11% (nausea) to 50% (heavy legs) in Serbia and from 12% (constipation) to 63% (cold) in Norway. Approximately 12% of the Norwegian and Serbian pharmacists offered referral to a physician as only advice for nausea in pregnancy, indicating a lack of confidence in or knowledge about this common ailment in pregnancy. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Large differences in counselling of pregnant women by pharmacists in Serbia and Norway were observed. Enhancement of pharmacists' knowledge about treatment of common ailments in pregnancy is needed and will enhance pharmacists' role in improving maternal health.

Nausea in pregnancy: attitudes among pregnant women and general practitioners on treatment and pregnancy care.

OBJECTIVE: Nausea and vomiting during pregnancy (NVP) is very common, and may have great impact on a woman's life. The aim of this study was to explore thoughts and attitudes among Norwegian pregnant women and GPs on treatment of NVP and pregnancy care. DESIGN: Focus-group study. SETTING AND SUBJECTS: Separate focus-group discussions were conducted with pregnant women and GPs. RESULTS: Two focus-group discussions were conducted with pregnant women and two with GPs. The GPs thought it was important to normalize NVP symptoms. However, the women felt their distress due to NVP was trivialized by the GPs. The women were sceptical towards the use of medicines while pregnant, and avoidance was sought despite being ill. The GPs appeared uncertain with respect to medical treatment of NVP, which was stated to be considered only after progression to quite severe symptoms. Sick leave seemed to be an important part of the treatment regime applied by the GPs. The women had good experiences with graded sick leave. CONCLUSION: This Norwegian study identifies attitudes among GPs and pregnant women that may act as obstacles to appropriate care for women with NVP. The pregnant women and the GPs seemed to talk at cross-purposes; GPs' normalization of the symptoms made the women feel that their distress due to NVP was trivialized by the GPs. Our results indicate that pregnant women with NVP requiring medical treatment probably need comprehensive and reassuring information about treatment options before considering using any medicines. KEY POINTS: Nausea and vomiting during pregnancy (NVP) is very common, and considered to be of clinical significance for 35% of women. While the GPs agreed on the importance of normalizing the symptoms, the women felt their distress was trivialized, and missed being properly evaluated. Both the GPs and the women showed a reluctant attitude to medical treatment of NVP. The GPs gave the impression of considering medical treatment only after progression of symptoms to becoming quite severe.

Treatment of nausea and vomiting during pregnancy -a cross-sectional study among 712 Norwegian women.

PURPOSE: The purposes of this study were to investigate the treatments used for nausea and vomiting of pregnancy (NVP) according to NVP severity among Norwegian women and to assess whether maternal characteristics and attitudes were related to the use of pharmacological treatment of NVP. METHODS: This is a cross-sectional Web-based study. Pregnant women and mothers with children ≤1 year of age were eligible to participate. Data were collected through an anonymous online questionnaire accessible from November 10th, 2014 to January 31st, 2015. RESULTS: In total, 712 women were included in the study, of which 62 (8.7 %), 439 (61.7 %) and 210 (29.5 %) had mild, moderate and severe NVP, respectively, according to the Pregnancy-Unique Quantification of Emesis (PUQE) classification. A total of 277 (38.9 %) women had used one or more antiemetics, of which meclizine, closely followed by metoclopramide, was the most commonly used. Different drug utilisation patterns were found between the groups of women with mild, moderate and severe NVP. Many with moderate or severe symptoms did not use any pharmacological treatment (70.2 and 32.9 %, respectively). Sick leave was given without initiating medical treatment in 266 (62.1 %) women. The women's beliefs about medicines had an important impact on their use of medicines for NVP. CONCLUSIONS: A large proportion of women suffered from moderate to severe symptoms of NVP, many of whom did not receive any pharmacological treatment. Many women, who had been on sick leave due to NVP, were not prescribed medicines.

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.

Pregnancy outcome after use of cranberry in pregnancy--the Norwegian Mother and Child Cohort Study.

BACKGROUND: Cranberry is one of the most commonly used herbs during pregnancy. The herb has been used traditionally against urinary tract infections. No studies are found that specifically address the risk of malformations after use of cranberry during pregnancy. The aim of the study was to investigate the safety of cranberry use during pregnancy, including any effects on congenital malformations and selected pregnancy outcomes. METHODS: The study is based on data from The Norwegian Mother and Child Cohort Study including more than 100,000 pregnancies from 1999 to 2008. Information on use of cranberry and socio-demographic factors was retrieved from three self-administered questionnaires completed by the women in pregnancy weeks 17 and 30, and 6 months after birth. Information on pregnancy outcomes was retrieved from the Medical Birth Registry of Norway. RESULTS: Among the 68,522 women in the study, 919 (1.3%) women had used cranberry while pregnant. We did not detect any increased risk of congenital malformations after use of cranberry. Furthermore, the use of cranberry was also not associated with increased risk for stillbirth/neonatal death, low birth weight, small for gestational age, preterm birth, low Apgar score (<7), neonatal infections or maternal vaginal bleeding in early pregnancy. Although an association was found between use of cranberry in late pregnancy and vaginal bleeding after pregnancy week 17, further sub-analyses of more severe bleeding outcomes did not support a significant risk. CONCLUSIONS: The findings of this study, revealing no increased risk of malformations nor any of the following pregnancy outcomes; stillbirth/neonatal death, preterm delivery, low birth weight, small for gestational age, low Apgar score and neonatal infections are reassuring. However, maternal vaginal bleeding should be investigated further before any firm conclusion can be drawn. Treatment guidelines on asymptomatic bacteriuria in pregnancy recommend antimicrobial therapy as the first line treatment. According to our data and the outcomes studied, cranberry does not appear to be a harmful adjunctive self-treatment.

Safety of ginger use in pregnancy: results from a large population-based cohort study.

PURPOSE: The objective of the study was to examine the safety of ginger use during pregnancy on congenital malformations and selected pregnancy outcomes. METHODS: The Norwegian Mother and Child Cohort study, a large population-based cohort, provided the data used in this study. Our study population consisted of 68,522 women. Data on ginger use and socio-demographic factors were retrieved from three self-administered questionnaires completed by the women during weeks 17 and 30 of the pregnancy and when their child was 6 months old. Data on pregnancy outcomes were provided by the Medical Birth Registry of Norway. RESULTS: Among the 68,522 women in the study, 1,020 (1.5 %) women reported using ginger during pregnancy. The use of ginger during pregnancy was not associated with any increased risk of congenital malformations. No increased risk for stillbirth/perinatal death, preterm birth, low birth weight, or low Apgar score was detected for the women exposed to ginger during pregnancy compared to women who had not been exposed. CONCLUSION: Use of ginger during pregnancy does not seem to increase the risk of congenital malformations, stillbirth/perinatal death, preterm birth, low birth weight, or low Apgar score. This finding is clinically important for health care professionals giving advice to pregnant women with NPV.