Attitudes toward COVID-19 vaccination of pregnant and lactating women in Hungary.

OBJECTIVES: This study has three purposes. First, we explore the percentage of the population that is vaccinated and the factors that contribute to whether or not an individual takes up COVID-19 vaccination. Second, we also look at how pregnant and lactating women (PLW) take up vaccination. Third, we reveal what the public think about PLW receiving vaccines. METHODS: Questionnaire data collection was carried out online using the quota method among Hungarians aged 18-65 with Internet access. The survey was carried out between 29th November and 11th December 2021. A total of 1,000 participants completed the questionnaire. RESULTS: A total of 66.4% of the respondents aged 18-65 received vaccination. There were significant differences across sociodemographic variables in vaccination: men and individuals with more education, better perceived financial status, and personal experience with COVID-19 were more likely to be vaccinated. PLW were less likely to be vaccinated, partly due to their fear of vaccines' side-effects. More than one third of the participants do not agree with PLW having COVID-19 vaccination. In general, attitudes toward vaccination of PLW differed significantly by social group. Men and individuals with tertiary education and better financial situation, who knew somebody who had died of COVID-19 infection, and who had been vaccinated were more likely to accept vaccination for both pregnant women and lactating mothers. CONCLUSIONS: Acceptance of receiving COVID-19 vaccination depends on social status; thus, targeted campaigns are required. In addition, PLW are afraid of vaccines' side effects, so they should be provided information, just as there is a need to increase public information on this topic.

Knowledge, Attitude and Practices towards COVID-19 Vaccine in Pregnant and Postpartum Women: A Cross-sectional Study

Introduction: Pregnant and lactating women have been included in the ongoing vaccination drive against Coronavirus Disease 2019 (COVID-19) by the Government of India. Despite the fact, the vaccination rates among this particular group were fairly dismal. Aim(s): To study the Knowledge, Attitude and Practices (KAP) related to the COVID-19 vaccine in pregnant and postpartum women in a tertiary care hospital. Material(s) and Method(s): This cross-sectional study was conducted in Obstetrics and Gynaecology wards and Outpatient Department, Smt. Kashibai Navale Medical College and General Hospital (tertiary care hospital), Pune, Maharashtra, India, from August 2021 to October 2021 among 251 pregnant and postpartum patients. The data was collected using a face-to-face questionnaire. The questionnaire included demographic characteristics of study participants and a set of questions to test the KAP towards COVID-19 vaccination in pregnancy. Result(s): A total of 251 pregnant and postpartum women, with a mean age of 24.54 years, were surveyed. Among all the participants, 223 (89.92%) knew about the existence of the COVID-19 vaccine, however, only 23 (9.16%) were vaccinated. The most common reasons for refusing the vaccine were concerns for their own safety (n=39, 17.5%) or that of the foetus (n=107, 48.1%), lack of awareness (58.5%), and lack of recommendation by healthcare workers (63.5%). Only 67.8% of subjects believed in the efficacy of the vaccine. Overall, 16 (9.41%) women with no history of miscarriages or abortions had taken the vaccine, whereas, seven (9.33%) participants with a history of miscarriage or abortions had taken the vaccine. Conclusion(s): The present study reported low acceptance of the COVID-19 vaccine in pregnant and postpartum women. Lack of awareness and concern for vaccine safety were the major reasons for this. Recognising the major reasons for vaccine hesitancy among this population will be useful for creating effective strategies to increase vaccine acceptance during this pandemic.Copyright © 2023 Journal of Clinical and Diagnostic Research. All rights reserved.

Detection of SARS-CoV-2-Specific Antibodies in Human Breast Milk and Their Neutralizing Capacity after COVID-19 Vaccination: A Systematic Review.

SARS-CoV-2 is the virus that causes the infectious disease known as Corona Virus Disease 2019 (COVID-19). The severe impact of the virus on humans is undeniable, which is why effective vaccines were highly anticipated. As of 12 January 2022, nine vaccines have obtained Emergency Use Listing by the World Health Organization (WHO), and four of these are approved or authorized by the Centers for Disease Control and Prevention (CDC) in the United States. The initial clinical trials studying COVID-19 vaccine efficacy excluded pregnant and lactating individuals, meaning that data on the effects of the vaccine on breast milk were lacking. Until today, none of the authorized vaccines have been approved for use in individuals under six months. During the first months of life, babies do not produce their own antibodies; therefore, antibodies contained in their mothers' breastmilk are a critical protective mechanism. Several studies have shown the presence of SARS-CoV-2 antibodies in the breast milk of women who have been vaccinated or had been naturally infected. However, whether these are protective is still unclear. Additionally, research on the BNT162b2 mRNA vaccine developed by Pfizer-BioNTech and the mRNA-1273 vaccine developed by Moderna suggests that these vaccines do not release significant amounts, if any, of mRNA into breast milk. Hence, there is no evidence that vaccination of the mother poses any risk to the breastfed infant, while the antibodies present in breast milk may offer protection against the virus. The primary objective of this systematic review is to summarize the current understanding of the presence of immunoglobulins in human milk that are elicited by SARS-CoV-2 vaccines and to evaluate their ability to neutralize the virus. Additionally, we aim to quantify the side effects experienced by lactating mothers who have been vaccinated, as well as the potential for adverse effects in their infants. This study is critical because it can help inform decision-making by examining the current understanding of antibody secretion in breastmilk. This is particularly important because, although the virus tends to be less severe in younger individuals, infants who contract the disease are at a higher risk of requiring hospitalization compared to older children.

Worries, beliefs and factors influencing perinatal COVID-19 vaccination: a cross-sectional survey of preconception, pregnant and lactating individuals.

BACKGROUND: COVID-19 vaccines are recommended for pregnant and lactating individuals, and there is substantial evidence for their safety and effectiveness. As the pandemic continues, information on worries and beliefs surrounding perinatal COVID-19 vaccination remains important to inform efforts aimed at improving vaccine uptake. Our objectives were to assess factors associated with COVID-19 vaccination among perinatal individuals; and to explore motivational factors associated with willingness to be vaccinated among unvaccinated perinatal individuals. METHODS: This was a cross-sectional web-based survey of preconception, pregnant, and lactating individuals in Canada. The outcomes of interest were vaccination with at least one dose of any COVID-19 vaccine and willingness to be vaccinated among unvaccinated individuals. Sample characteristics were summarized using frequencies and percentages. The association between eight prespecified risk factors and two outcomes (vaccination status and willingness to be vaccinated) was assessed by logistic regression. Odds ratios (OR) and 95% confidence intervals (CI) were calculated for the total sample, and across perinatal sub-groups. RESULTS: Among 3446 survey respondents, there were 447 (13.0%) preconception, 1832 (53.2%) pregnant, and 1167 (42.4%) lactating. There were 1460 (42.4%) and 1982 (57.5%) who were vaccinated and unvaccinated, respectively. Factors positively associated with COVID-19 vaccine status were speaking to a healthcare provider about vaccination during the perinatal period (aOR:2.35, 95% CI:1.97-2.80) and believing that the COVID-19 vaccine is effective (aOR:1.91, 95% CI:1.46-2.48). Factors negatively associated with vaccine status included worries about fetal growth and development (aOR:0.55, 95% CI:0.43-0.70) and future child behavioral/neurodevelopmental problems (aOR:0.59, 95% CI:0.46-0.75). Among unvaccinated individuals specifically, characteristics positively associated with willingness to vaccinate were speaking to a healthcare provider (aOR:1.67, 95% CI:1.32-2.12) and believing the COVID-19 vaccine is effective (aOR:3.56, 95% CI:2.70-4.69). Factors negatively associated with willingness were concerns over infertility (aOR:0.66, 95% CI:0.49-0.88), fetal growth and development (aOR:0.33, 95% CI:0.24-0.46), and future child behavioral/neurodevelopmental problems (aOR:0.64, 95% CI:0.48-0.84). CONCLUSIONS: In this Canadian perinatal population, approximately 42% reported COVID-19 vaccination. Among unvaccinated individuals, willingness to receive vaccination was high (73%). Factors enhancing vaccine willingness included discussions with healthcare providers and believing the vaccine was effective. Concerns regarding vaccine safety, particularly with respect to fetal/child development, were the greatest barriers to vaccine uptake.

COVID-19 Vaccine Acceptance Among Pregnant and Lactating Women in Saudi Arabia.

Background The acceptance of vaccines among pregnant and breastfeeding women is vital to alleviate the risk of contracting and transmitting coronavirus disease 2019 (COVID-19). Therefore, we aimed to assess the COVID-19 vaccine acceptance among pregnant and breastfeeding/lactating women and the factors associated with the acceptance of the COVID-19 vaccine in Saudi Arabia. Methodology A cross-sectional survey was conducted among pregnant and breastfeeding women living in Saudi Arabia. A 23-item, self-administered questionnaire was used to assess the COVID-19 vaccine acceptance among pregnant or lactating women. Results A total of 160 (53.3%) pregnant women and 140 (46.7%) breastfeeding/lactating mothers participated in the study. When the participants were asked, "Have you been vaccinated or are you planning to take the vaccine during pregnancy or breastfeeding/lactation?" 164 (54.7%) responded with "Yes." When compared with breastfeeding/lactating mothers (54, 38.6%), pregnant women had more concerns about the efficacy and safety of COVID-19 vaccination (77 (48.1%); p = 0.043). The probability of rejecting COVID-19 vaccination was higher among breastfeeding/lactating women with a lower education level than those with a tertiary education level (odds ratio = 3.42, confidence interval = 1.24, 9.45, p = 0.018). Conclusions This study reported high acceptance of COVID-19 vaccination in a sample of breastfeeding/lactating women. Concern about vaccine safety among many pregnant women was the major reason for hesitancy. Factors such as low education, concerns regarding the efficacy and safety of the vaccine, and doctors' (e.g., obstetrician and gynecologist) recommendations for the COVID-19 vaccine were associated with vaccine acceptance.

Knowledge and Awareness Regarding Breast Feeding and Covid-19 Vaccination among Pregnant and Lactating Mothers Attending Opd in a Service Hospital during Covid-19 Pandemic

Aim: To assess the Knowledge and Awareness regarding Breastfeeding and COVID-19 vaccination among Pregnant and Lactating Mothers attending OPD in a Service Hospital during COVID-19 Pandemic. Material(s) and Method(s): Hospital based cross sectional study. Sample size of 380 Pregnant and Lactating Mothers attending OPD antenatally or postnatally were included in the study. Ethics committee approval was taken. A peer reviewed predesigned questionnaire was used to obtain information after taking consent. Demographic data and Knowledge of Mothers regarding Breastfeeding and COVID-19 Vaccination data was collected and analyzed. Result(s): Our Study revealed knowledge and awareness regarding Breastfeeding and COVID-19 Vaccination in Pregnant and Lactating Mothers during COVID-19 Pandemic in a Service Hospital to be 53% and 57% respectively. Our Study also found a significant correlation between Age and Education of Mothers and their Knowledge regarding Breastfeeding in Pregnant and Lactating Mothers during COVID-19 Pandemic. A significant Correlation was found between Education of Mothers and their Knowledge regarding COVID-19 Vaccine in Pregnant and Lactating Mothers during COVID-19 Pandemic. Conclusion(s): This study emphasizes the need to focus on promotion of breast feeding and COVID-19 Vaccination in Pregnant and Lactating during COVID-19 Pandemic. These simple steps may contribute in lowering Neonatal and Infant Mortality rates. Breastfeeding must continue after Maternal COVID-19 vaccination. Copyright © 2022 Ubiquity Press. All rights reserved.

Breastfeeding patterns and stress among lactating women in Pune during the COVID-19 pandemic

Lactating mothers (n=126) residing in Pune, Maharashtra were interviewed to assess the prevalence of stress, rate of exclusive breastfeeding (EBF), and its association with different demographic factors. 75.4% mothers were found to be moderately stressed. Rate of EBF was 62.7%. Moderate stress and testing positive for COVID-19 were significantly negatively associated with EBF (P < 0.001).

Food behavior of the Algerian population at the time of the COVID-19: the first survey carried out in the western Algerian region

The world has been dealing with a coronavirus 2019 (COVID-19) pandemic since January 2020, which is caused by the severe acute respiratory syndrome coronavirus 2. To avoid the spread of the disease, drastic measures were implemented. These measures, however, can have a negative impact on people's health because they influence their behavior. The COVID-19 pandemic has had an impact on people's lifestyles, including food consumption, when combined with quarantine measures. In order to shed light on the Algerian population's food habits during the pandemic, an observational and descriptive epidemiological study on 640 people, whether or not they were infected with COVID-19, was conducted in the western region of Algeria. The study used an online and face-to-face interview questionnaire focused on the pandemic's elapsed period between February and September 2020. Our findings showed that half of our participants had influenza during the study period, but only 37.53% of them had COVID-19. As a result, almost all of our test-positive respondents (95%) followed a medical protocol automatically. Furthermore, 31.57% of them stated that they were following a specific diet to avoid COVID-19 contamination. This resulted in a clear shift in Algerian cuisine (70.31%), with processed foods (3.47%) and modern dishes (5%) made outside the home consumed at low levels, while consumption of vegetables (22.39%), fruits (15.87%), and traditional dishes (11.95%) increased. Vulnerable people, such as breastfeeding mothers, were faced with the double burden of nourishing their babies while being Covid-positive, causing 35/40 cases to discontinue breastfeeding completely. Overall, 83.09% of our participants were malnourished. This study is the first draft in the understanding of Algerians' dietary behavior during the COVID-19 pandemic, and it could be used effectively in the delineation of strategies for correction and support of citizens in underdeveloped countries.

Is aflatoxin more in the milk of lactating mothers who have previously had COVID-19?

Background: Breast milk provides the ideal nutrition for infants. It has a nearly perfect mix of vitamins, protein, and fat. Breastfeeding has many health benefits for both the mother and infant. Breast milk contains all the nutrients an infant needs in the first six months of life. The present study aimed to measure aflatoxin M1 (AFM1) levels in breast milk and identify nutritional and socio-demographic factors associated with AFM1 levels.

The impact of COVID-19 pandemic on breastfeeding and birth care. The importance of recovering good practices

The SARS-CoV-2 pandemic has had a major impact on birth care and lactation. The lack of knowledge regarding the transmission mechanisms and the potential risks for the mother and the newborn, even when the vertical transmission of the virus has not been demonstrated, has led to the abandonment of practices such as skin-to-skin and the early initiation of breastfeeding (BF), which offer great benefits for maternal and child health. Taking into account the available scientific evidence and the protective effect of BF, the World Health Organization (WHO), and other organisms recommend, in cases of suspected or confirmed SARS-CoV-2 infection of the mother, maintaining mother-child contact and BF, adopting preventive measure procedures to minimize the risk of contagion. These measures include hand hygiene, before and after contact with the newborn and the use of a mask. If a temporary separation of mother and child is required, it is recommended to feed the newborn with expressed breast milk. The presence of IgA antibodies against SARSCoV- 2 has been confirmed in the milk of infected women, so BF could reduce the clinical impact of the disease in the infant, if it becomes infected.

What to Expect from COVID-19 and from COVID-19 Vaccine for Expecting or Lactating Women.

Recent studies identified pregnancy as a high-risk condition for the development of maternal-fetal complications in the case of the SARS-CoV-2 infection. Therefore, the scientific community is now considering pregnant women a "fragile" category that should be vaccinated with high priority. The number of pregnant women undergoing hospitalization since summer 2021, including Intensive Care Unit admission, is growing, as well as the risk of preterm birth. Evidence from both animals and humans suggest that, similarly to other vaccines routinely administered in pregnancy, COVID-19 vaccines are not crossing the placenta, do not increase the risk of miscarriage, preterm birth, stillbirth, the birth of small gestational age neonates, as well as the risk of congenital abnormalities. To date, the World Health Organization and scientific literature are promoting and encouraging the vaccination of all pregnant and lactating women. The aim of our narrative review is to present the available literature regarding this issue with the aim to provide appropriate answers to the most frequent requests, doubts, and fears that have led many expecting and lactating women not to become vaccinated during this pandemic period.

Attitude of pregnant and lactating women toward COVID-19 vaccination in Jordan: a cross-sectional study.

OBJECTIVES: The objective of this study was to survey pregnant and lactating toward COVID-19 vaccination in Jordan and determine the predictors of this attitude. METHODS: This study used a 10 min anonymous, online, cross-sectional survey to collect data. The survey was carried out between September and October 2021. Eligible study participants included all pregnant and lactating women in Jordan. The participants were recruited through social media, midwives, and gynecologists. Survey was used to collect data from the participants. RESULTS: The mean attitude of pregnant and lactating women toward COVID vaccination was moderate 71 (SD=100.5). Many factors were predicted the attitude of pregnant and lactating women toward COVID-19 vaccination. The factors were source of data regarding COVID-19 (B=-0.140, p=0.009), level of income (B=-0.141, p=0.009), and social status (B=0.130, p=0.034). These results mean lower income, people who frequently hearing news from news channel or ministry of health and married are showed more positive attitude toward COVID-19 vaccination for children. CONCLUSIONS: This is a large national study regarding attitude of pregnant and lactating women toward COVID-19 vaccination in Jordan. This study found that more than 50% for the parents were hesitant to allow their children to receive COVID-19 vaccination. There were no differences between pregnant and lactating women toward COVID-19 vaccination.

How to think about severe acute respiratory syndrome coronavirus 2 vaccination for pregnant and lactating women in China. / å¦‚ä½•çœ‹å¾ ä¸­å›½å¦Šå¨ æœŸåŠå“ºä¹³æœŸå¥³æ€§æ–°åž‹å† çŠ¶ç— æ¯’ç–«è‹—æŽ¥ç§ï¼Ÿ.

The coronavirus disease 2019 (COVID-19) continues to spread around the world, and how to build an immune barrier against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the population is the work we need to do for a long time in the future. The vaccination is an important strategy to construct and improve the herd immunity barrier. Therefore, our country is currently actively and extensively implementing the anti-epidemic policy of SARS-CoV-2 vaccination. However, because of insufficient data on the safety of the SARS-CoV-2 vaccine in the population, especially the lack of clinical research in pregnant and lactating women, China has adopted a conservative approach on whether women in this special physiological period receive SARS-CoV-2 vaccine based on the safe consideration. However, with the widespread application of the SARS-CoV-2 vaccine in the prevention and control of the global epidemic, and the emergence of a large number of clinical research evidences at home and abroad, if we still exclude pregnant and lactating women from the vaccinated population, this part of the population will be fully exposed to the SARS-CoV-2 threat, which will weak the national prevention and control policy. Therefore, it is necessary to reconsider the vaccination of people in this special physiological period based on the experience of vaccination at home and abroad.

COVID-19 Outbreak Challenges in Indian Migrant Pregnant and Lactating Mothers: Learnt Lesson Demands Phronesis and Hierarchical Strategies for Such Future Pandemics.

INTRODUCTION: The coronavirus disease (COVID-19) has been found to influence almost all sectors starting from socio-religious to educational and environmental levels. However, the systematically planned or unplanned implementation of sudden lockdown across the globe, including India, has pushed the migrant workers into huge troubles. Without savings and transport systems, food security and other problems pushed migrant workers to walk to home from working places covering over 1000 km. Walking under the hot sun with heavy luggage and child in the womb or arm has affected the lactating mothers or pregnant women the most. The objective of this review article was to analyse the problems faced especially by the women migrant workers in India in order to point out and to adapt future strategies for their protection. METHODS: All published relevant literature from scientific sources and reputed news channels are considered to write the current review. RESULTS: Tremendous adverse effects of COVID-19 have been observed at social/cultural/religious/economic levels and other sectors of the society albeit its huge progressive but temporary effects are also observed on environment. The environment is self-regenerating, while the economy is pushed to an unseen manner. This is because many countries including India have adopted social lockdowns as a measure of prevention against the highly contagious disease. The results of lockdowns are encourageable as far as the reduced infection and death rate is concerned. For example, India being the second largest populous country with less advanced healthcare system is enjoying a comparatively low rate of death in COVID-19. However, sudden lockdowns followed by shutdowns mediated by industrial closure have pushed many migrant workers to walk to home by passing over even >1000 kilometres of distance on barefoot. Without transport systems, proper food and medications, many migrant workers faced un-imaginary difficulties, and some of them have also died on the way. Pregnant women and lactating mothers were also in the list and found to face unseen problems while migrating to their home from their working places with a load of child in the womb or on arm. So, phronesis of such problems and hierarchical strategies are suggested. CONCLUSION: Since such zoonotic pandemics cannot be avoided in the near future, solid future strategies must be adopted by different nations especially under developed and poor countries to tackle the problem of the migrant workers including the pregnant women and the lactating mothers.

College of obstetricians and gynaecologists of South Africa - recommendations for COVID-19 vaccination in pregnancy

Pregnant and lactating women were excluded from initial COVID-19 vaccine trials;thus data to guide vaccine decision-making are lacking. In the largest US study comparing pregnant and non-pregnant women, pregnant women were significantly more likely to require intensive care and mechanical ventilation than non-pregnant women of the same age.1 Black women experienced a disproportionally higher number of deaths. Preliminary data from the South African Obstetric Survey Systems suggests that majority of COVID-positive pregnant women west diagnosed in the third trimester of pragnancy.1 One in six pregnant women admitted to hospital required admission to the intensive care unit, while one in six teen women died.

Secretory IgA and T cells targeting SARS-CoV-2 spike protein are transferred to the breastmilk upon mRNA vaccination.

In view of the scarcity of data to guide decision making, we evaluated how BNT162b2 and mRNA-1273 vaccines affect the immune response in lactating women and the protective profile of breastmilk. Compared with controls, lactating women had a higher frequency of circulating RBD memory B cells and higher anti-RBD antibody titers but similar neutralizing capacity. We show that upon vaccination, immune transfer to breastmilk occurs through a combination of anti-spike secretory IgA (SIgA) antibodies and spike-reactive T cells. Although we found that the concentration of anti-spike IgA in breastmilk might not be sufficient to directly neutralize SARS-CoV-2, our data suggest that cumulative transfer of IgA might provide the infant with effective neutralization capacity. Our findings put forward the possibility that breastmilk might convey both immediate (through anti-spike SIgA) and long-lived (via spike-reactive T cells) immune protection to the infant. Further studies are needed to address this possibility and to determine the functional profile of spike T cells.

Willingness to Receive COVID-19 Vaccine and Its Determinant Factors Among Lactating Mothers in Ethiopia: A Cross-Sectional Study.

BACKGROUND: The World Health Organization, the United States Society for Maternal-Fetal Medicine, the American College of Obstetricians and Gynaecologists, the Academy of Breastfeeding Medicine, the Food and Drugs Administration, and the Centers for Disease Control recommend COVID-19 vaccination to lactating mothers without discontinuity of breastfeeding. Despite this recommendation, willingness to receive COVID-19 vaccine and its determinant factors among lactating mothers were not studied in Ethiopia. Hence, this study aimed to assess willingness to receive COVID-19 vaccine and its determinant factors among lactating mothers in Ethiopia. METHODS: An institutional-based cross-sectional study design was employed in southern Ethiopia from February 1 up to March 15, 2021. Multistage sampling technique was used to select study participants. Structured and face-to-face interviewer-administered questionnaire was used to collect data. Data were clean, coded, and entered into Epi-Data version 4.2.0 and exported to SPSS version 23 software package for analysis. Bivariable and multivariable analysis were used to identify associated factors. Adjusted odds ratio along with 95% CI was used to measure the strength of association. RESULTS: The prevalence of willingness to receive COVID-19 vaccination was found to be 61% (95% CI; 56.9-65.1%). Urban residence [AOR=2.5, (95% CI; 1.62-3.91)], having secondary and above maternal educational status [AOR=2.8, (95% CI; 1.51-4.21)] mothers who had got immunization counselling [AOR=3.4, (95% CI; 1.95-5.91)], good knowledge about vaccine [AOR=2.6, (95% CI; 1.84-3.47)], and good adherence to COVID-19 mitigation measures [AOR=3.2, (95% CI; 1.91-5.63)] were determinant factors of willingness to receive COVID-19 vaccine. CONCLUSION: Urban residence, secondary and above maternal education status, immunization counselling, good knowledge about the vaccine, and good adherence to COVID-19 mitigation measures were determinant factors of willingness to receive COVID-19 vaccine. Therefore, health professionals should counsel about the merits of COVID-19 vaccination, and enhance maternal awareness about the vaccine is recommended.

Drug development research in pregnant and lactating women.

Pregnant and lactating women are considered "therapeutic orphans" because they generally have been excluded from clinical drug research and the drug development process owing to legal, ethical, and safety concerns. Most medications prescribed for pregnant and lactating women are used "off-label" because most of the clinical approved medications do not have appropriate drug labeling information for pregnant and lactating women. Medications that lack human safety data on use during pregnancy and lactation may pose potential risks for adverse effects in pregnant and lactating women as well as risks of teratogenic effects to their unborn and newborn babies. Federal policy requiring the inclusion of women in clinical research and trials led to considerable changes in research design and practice. Despite more women being included in clinical research and trials, the inclusion of pregnant and lactating women in drug research and clinical trials remains limited. A recent revision to the "Common Rule" that removed pregnant women from the classification as a "vulnerable" population may change the culture of drug research and drug development in pregnant and lactating women. This review article provides an overview of medications studied by the Obstetric-Fetal Pharmacology Research Units Network and Centers and describes the challenges in current obstetrical pharmacology research and alternative strategies for future research in precision therapeutics in pregnant and lactating women. Implementation of the recommendations of the Task Force on Research Specific to Pregnant Women and Lactating Women can provide legislative requirements and opportunities for research focused on pregnant and lactating women.

Mental health effect of COVID-19 pandemic among women who are pregnant and/or lactating: A systematic review and meta-analysis.

OBJECTIVES: The purpose of this study is to examine the effects of coronavirus disease 2019 pandemic on the prevalence of anxiety, depression, stress, insomnia, and social dysfunction among pregnant and/or lactating women and to measure the global pooled prevalence of mental health effects among these populations in the era of coronavirus disease 2019 pandemic. METHODS: Comprehensive literature searching was conducted and studies published from 1 January 2020 to 30 September 2020 reporting the prevalence of anxiety, depression; stress, insomnia, and social dysfunctions were included. The pooled prevalence of anxiety, depression, stress, insomnia, and social dysfunctions was estimated using a random-effect model. In this study, all statistical analyses were performed using STATA (version 15) software. RESULTS: There were a total of 19 studies included in the meta-analysis, of which 16, 14, 4, 2, and 2 studies were included in computing the pooled prevalence of anxiety, depression, stress, insomnia, and social dysfunction, respectively. The pooled prevalence of anxiety was 33% (95% confidence interval: 50%-61%), with significant heterogeneity between studies (I2 = 99.68%, p = 0.001). The pooled prevalence of depression was 27% (95% confidence interval: 9%-45%), with remarkable heterogeneity between studies (I2 = 99.29%, p = 0.001). Likewise, the pooled prevalence of stress was 56% (95% confidence interval: 30.07%-82.22%), with significant heterogeneity between studies (I2 = 98.8%, p = 0.0001). The pooled prevalence of social dysfunction was 24.3% (95% confidence interval: 13.41%-62.03%), with significant heterogeneity between studies (I2 = 97.5%, p = 0.0001) and finally, the pooled prevalence of insomnia was 33.53% (95% confidence interval: 3.05%-64.0%), with significant heterogeneity between studies (I2 = 99.6%, p = 0.0001). CONCLUSIONS: In this study, the mental health effects of the COVID-19 pandemic among pregnant and lactating women were found to be significant. Stress was the most common mental health problem in these population groups. Therefore, policymakers and health planners should give great emphasis to addressing maternal mental well-being during and after this global health crisis. Maternal mental health must be one of the international and national public health priority agendas to enhance the well-being of pregnant and lactating women. Besides, giving psychological support to pregnant and lactating women may reduce the long-term negative effects of this pandemic.