Mental health status of pregnant and breastfeeding women during the COVID-19 pandemic-A multinational cross-sectional study.

INTRODUCTION: Evidence on perinatal mental health during the coronavirus disease 2019 (COVID-19) pandemic and its potential determinants is limited. Therefore, this multinational study aimed to assess the mental health status of pregnant and breastfeeding women during the pandemic, and to explore potential associations between depressive symptoms, anxiety, and stress and women's sociodemographic, health, and reproductive characteristics. MATERIAL AND METHODS: A cross-sectional, web-based study was performed in Ireland, Norway, Switzerland, the Netherlands, and the UK between 16 June and 14 July 2020. Pregnant and breastfeeding women up to 3 months postpartum who were older than 18 years of age were eligible. The online, anonymous survey was promoted through social media and hospital websites. The Edinburgh Depression Scale (EDS), the Generalized Anxiety Disorder seven-item scale (GAD-7), and the Perceived Stress Scale (PSS) were used to assess mental health status. Regression model analysis was used to identify factors associated with poor mental health status. RESULTS: In total, 9041 women participated (including 3907 pregnant and 5134 breastfeeding women). The prevalence of major depressive symptoms (EDS ≥ 13) was 15% in the pregnancy cohort and and 13% the breastfeeding cohort. Moderate to severe generalized anxiety symptoms (GAD ≥ 10) were found among 11% and 10% of the pregnant and breastfeeding women. The mean (±SD) PSS scores for pregnant and breastfeeding women were 14.1 ± 6.6 and 13.7 ± 6.6, respectively. Risk factors associated with poor mental health included having a chronic mental illness, a chronic somatic illness in the postpartum period, smoking, having an unplanned pregnancy, professional status, and living in the UK or Ireland. CONCLUSIONS: This multinational study found high levels of depressive symptoms and generalized anxiety among pregnant and breastfeeding women during the COVID-19 outbreak. The study findings underline the importance of monitoring perinatal mental health during pandemics and other societal crises to safeguard maternal and infant mental health.

The effect of a pharmacist consultation on pregnant women's quality of life with a special focus on nausea and vomiting: an intervention study.

BACKGROUND: Maternal wellbeing and quality of life (QOL) are increasingly being recognized as important for healthy pregnancies. The aim of this study was to investigate the impact of a pharmacist consultation on pregnant women's QOL focusing on nausea and vomiting in pregnancy (NVP), and patient satisfaction. METHODS: For this intervention study in 14 community pharmacies, women in early pregnancy were recruited and assigned to a pharmacist consultation (intervention) or standard care (control). The consultation aimed to address each woman's concerns regarding medications and pregnancy-related ailments. Data were collected through online questionnaires at baseline (Q1) and during the second trimester (Q2). The intervention group completed an additional satisfaction questionnaire after the consultation was completed. The primary outcome was the impact of the intervention on the Quality of Life Scale (QOLS) scores between the first and second trimesters. The impact of the intervention was assessed by linear regression, and secondary analyses were performed to assess effect modification by NVP. RESULTS: Of the 340 women enrolled in the study, we analyzed data for 245. Half (170/340) of the original participants were allocated to the intervention group, of whom 131 received the pharmacist consultation. Most women (75%, 78/96) reported that the consultation was useful to a large/very large extent. The consultation had no overall impact on QOLS scores between the first and the second trimesters compared with standard care (adjusted ß: 0.7, 95% CI: -2.1, 3.4). The impact of the intervention on QOLS was greater amongst women with moderate/severe NVP (adjusted ß: 3.6, 95% CI: -0.6, 7.7) compared to those with no/mild NVP (adjusted ß: -1.4, 95% CI: -5.1, 2.2) (interaction term study group*NVP severity, p = 0.048). CONCLUSIONS: The pregnant women highly appreciated the pharmacist consultation, but the intervention did not affect their QOL scores compared with standard care. Future studies should further explore the effect of a pharmacist consultation specifically for NVP and on other outcomes such as use of health care services and medication use in pregnancy. TRIAL REGISTRATION: Retrospectively registered in ClinicalTrials.gov (identifier: NCT04182750 , registration date: December 2, 2019).

Use of Decision Support Tools to Empower Pregnant Women: Systematic Review.

BACKGROUND: Women face many health-related decisions during pregnancy. Digitalization, new technology, and a greater focus on empowering patients have driven the development of patient-centered decision support tools. OBJECTIVE: This systematic review provides an overview of studies investigating the effect of patient-centered decision support tools for pregnant women. METHODS: We searched 5 online databases, MEDLINE, EMBASE, Web of Science, PsycINFO, and Scopus, from inception to December 1, 2019. Two independent researchers screened titles, abstracts, and full-texts against the inclusion criteria. All studies investigating the effect of patient-centered decision support tools for health-related issues among pregnant women were included. Study characteristics and results were extracted using the review management tool Rayyan and analyzed according to topic, type of decision support tools, control group, outcome measurements, and results. RESULTS: The 25 eligible studies covered a range of health topics, including prenatal screening (n=10), gestational diabetes and weight gain (n=7), lifestyle (n=3), blood pressure and preeclampsia (n=2), depression (n=1), asthma (n=1), and psychological well-being (n=1). In general, the use of decision support tools increased women's knowledge, and recording symptoms enhanced satisfaction with maternity care. CONCLUSIONS: The opportunities created by digitalization and technology should be used to develop innovative patient-centered decision support tools tailored to support pregnant women. Effect on clinical outcomes should be documented.

Impact of a primary care pharmacist consultations on pregnant women's medication use: the SafeStart intervention study linked to a national prescription database.

BACKGROUND: Prior studies show that pharmacist consultations are highly appreciated by pregnant women and feasible in community pharmacies. However, it is unknown whether such counseling has an impact on medication use during pregnancy. AIM: This study aimed to assess whether a pharmacist consultation in early pregnancy was associated with pregnant women's medication use, with a focus on antiemetic medications. METHOD: The SafeStart study recruited Norwegian pregnant women in the first trimester between February 2018 and February 2019. Women in the intervention group received a pharmacist consultation in a community pharmacy or by phone. A follow-up questionnaire was completed 13 weeks after enrollment. Data from the SafeStart study were linked to the Norwegian Prescription Database. Logistic regression was used to assess the association between the pharmacist intervention and medication use in the second trimester. RESULTS: The study included 103 women in the intervention group and 126 in the control group. Overall prescription fills in the first and second trimesters were 55% and 45% (intervention group) and 49% and 52% (control group), respectively. In total, 16-20% of women in the first trimester and 21-27% of women in the second trimester had a prescription for antiemetics. The pharmacist intervention was not associated with women's medication use in the second trimester. CONCLUSION: This study did not detect an impact of a pharmacist consultation on pregnant women's use of medications. In the future, pharmacist consultations should focus on other outcome factors, such as risk perception, knowledge level, and the use of other health care services. Trial registration The SafeStart study is registered with ClinicalTrials.gov (identifier: NCT04182750, registration date: December 2, 2019).

Impact of a Mobile Application for Tracking Nausea and Vomiting During Pregnancy (NVP) on NVP Symptoms, Quality of Life, and Decisional Conflict Regarding NVP Treatments: MinSafeStart Randomized Controlled Trial.

BACKGROUND: Pregnant women are active users of mobile apps for health purposes. These apps may improve self-management of health-related conditions. Up to 70% of pregnant women experience nausea and vomiting (NVP). Even mild NVP can significantly reduce quality of life (QoL), and it can become an economic burden for both the woman and society. NVP often occurs before the first maternal care visit; therefore, apps can potentially play an important role in empowering pregnant women to recognize, manage, and seek appropriate treatment for NVP, when required. OBJECTIVE: This study investigated whether the MinSafeStart (MSS) mobile app could impact NVP-related symptoms, QoL, and decisional conflict regarding NVP treatment. METHODS: This randomized controlled trial enrolled 268 pregnant women with NVP in Norway from 2019 to 2020. The intervention group had access to the MSS app, which could be used to track NVP symptoms and access tailored advice. NVP severity was rated with the Pregnancy Unique Quantification of Emesis (PUQE) score. The control group followed standard maternal care. We collected data on maternal baseline characteristics, NVP severity, QoL, and decisional conflict using 2 sets of online questionnaires. One set of questionnaires was completed at enrollment, and the other was completed after 2 weeks. We performed linear regression analyses to explore whether the use of the MSS app was associated with NVP severity, QoL, or decisional conflict. RESULTS: Among the 268 women enrolled in the study, 192 (86.5%) completed the baseline questionnaires and were randomized to either the intervention (n=89) or control group (n=103). In the intervention group, 88 women downloaded the app, and 468 logs were recorded. In both groups, women were enrolled at a median of 8 gestational weeks. At baseline, the average PUQE scores were 4.9 and 4.7; the average QoL scores were 146 and 149; and the average DCS scores were 40 and 43 in the intervention and control groups, respectively. The app had no impact on NVP severity (aß 0.6, 95% Cl -0.1 to 1.2), QoL (aß -5.3, 95% Cl -12.5 to 1.9), or decisional conflict regarding NVP treatment (aß -1.1, 95% Cl -6.2 to 4.2), compared with standard care. CONCLUSIONS: Tracking NVP symptoms with the MSS app was not associated with improvements in NVP symptoms, QoL, or decisional conflict after 2 weeks, compared with standard care. Future studies should include a process evaluation to improve our understanding of how pregnant women use the app and how to optimize its utility within maternity care. Specifically, studies should focus on how digital tools might facilitate counseling and communication between pregnant women and health care providers regarding NVP management during pregnancy. TRIAL REGISTRATION: ClinicalTrails.gov (NCT04719286): https://www.clinicaltrials.gov/ct2/show/NCT04719286.

Authorship Correction: Impact of a Mobile Application for Tracking Nausea and Vomiting During Pregnancy (NVP) on NVP Symptoms, Quality of Life, and Decisional Conflict Regarding NVP Treatments: MinSafeStart Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/36226.].

Antihistamine use during breastfeeding with focus on breast milk transfer and safety in humans: A systematic literature review.

Current data on use of antihistamines during breastfeeding and risks to the breastfed infant are insufficient. The aim of this systematic review was to provide an overview of studies measuring the levels of antihistamines in human breast milk, estimating the exposure for breastfed infants and/or reporting possible adverse effects on the breastfed infant. An additional aim was to review the antihistamine product labels available in the European Union (EU) and the United States. We searched seven online databases and identified seven human lactation studies that included 25 mother-infant pairs covering cetirizine, clemastine, ebastine, epinastine, loratadine, terfenadine and triprolidine. In addition, one study investigated the impact of chlorpheniramine or promethazine on prolactin levels among 17 women, and one study investigated possible adverse drug reactions in 85 breastfed infants exposed to various antihistamines. The relative infant dose was below 5% for all antihistamines, ranging from 0.3% for terfenadine to 4.5% for clemastine. Most product labels of the 10 antihistamines with available information in both the EU and the United States reported lack of evidence and recommended to avoid use during breastfeeding. The knowledge gap on antihistamines and lactation is extensive, and further human studies are warranted to ensure optimal treatment of breastfeeding women with allergy.

Community pharmacist counseling in early pregnancy-Results from the SafeStart feasibility study.

BACKGROUND: Community pharmacists are available to counsel women in early pregnancy, but no studies have assessed the feasibility of such a service. OBJECTIVE: To test the feasibility of a pharmacist consultation in early pregnancy and to inform the design of a definitive trial. SETTING: Six community pharmacies in Norway from Oct. to Dec. 2017. METHOD: We evaluated recruitment approaches and an automatic data preprocessing system (ADPS) to enroll, assign participants, and distribute questionnaires. Women (≥18 years) in early pregnancy were eligible for inclusion. Participants were assigned to a pharmacist consultation (intervention group) or standard care (control group). The intervention aimed to address each woman's concerns and needs regarding medications and ailments in pregnancy, and was documented on a standard form. The women's acceptability of the intervention was measured by a questionnaire. MAIN OUTCOME MEASURES: Appropriate recruitment approaches, workflow of the ADPS, and women's acceptability of the intervention. RESULTS: Of the 35 participants recruited, 19 were recruited through Facebook. The ADPS worked well. Treatment of nausea and vomiting (NVP) (10/11) and general information about medications (8/11) were frequently discussed during the consultations (n = 11). The women reported high satisfaction with the consultation. Having the option of telephone and follow-up consultations was important to the women. CONCLUSION: It is feasible to provide community pharmacist consultations in early pregnancy. In a definitive study, the consultations should focus on NVP and general medication use and further explore social media as a recruiting tool. Both in-pharmacy and telephone consultations should be offered to deliver the intervention.