TITLE: Anxiety of pregnant women in time of catastrophic events, including COVID-19 pandemic – a systematic review and metanalysis protocol.
AUTHORS: Stepan Feduniw, Jan   Modzelewski, Dorota Sys, Sebastian   Kwiatkowski, Anna   Kajdy

[DESCRIPTION]
<div class = "text-blocks"><div class = "text-block"><div class = "justify" style = "text-align:left"><span style = "font-weight:bold;">Introduction</span><span>. The article presents a rapid systematic review protocol. The aim is to assess the current studies about the influence of exposure to a natural disaster or catastrophic event on the prevalence of anxiety among pregnant women worldwide. We hope that this knowledge will provide better understanding of the current situation related to the COVID-19 pandemic. There are more than 30 million coronavirus infection cases worldwide, and many countries have declared states of a natural disaster. Therefore, we believe that experiences from previous natural disasters on maternal anxiety could be an important lesson for planning intervention in this group of patients. </span></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"><span style = "font-weight:bold;">Methods and Analysis</span><span>. For the purpose of this systematic review the following databases will be screened Pubmed / MEDLINE, Web of Science, Cochrane Library, EMBASE, Google Scholar. This literature review will compare the prevalence of anxiety among pregnant women during a catastrophic event including and pregnant women with pregnancy studied in a naturally stable setting. Exposure to natural disasters or other catastrophic events onmaternalanxiety. The risk of bias will be assessed independently during the data extraction process by at least two researchers using the Newcastle-Ottawa Scale.</span></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"><span style = "font-weight:bold;">Ethics and Dissemination</span><span>. A manuscript will be prepared for submission to a peer-reviewed journal. The current protocol is made using PRISMA-P guidelines and were registered in PROSPERO with ID-number: CRD42020178944.</span></div></div></div>

[STEPS]
?. [INTRODUCTION]
The perinatal period is often a time of maternal emotional distress related to the pregnancy itself. Women are concerned with fetal wellbeing and labor outcome. Besides the pregnancy itself, there are several risk factors correlated with a higher prevalence of anxiety1. Risk factors of anxiety include adverse childhood events (overprotective or harsh parenting, maltreatment, and physical punishment). Parental history of mental disorders and low socioeconomic status are also described as increasing the risk of anxiety1–3.
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							One of the adverse influences on the mental health of pregnant women could be insecurity related to catastrophic events or the occurrence of a natural disaster. A catastrophic event is defined as a disaster or accident which takes place within a designated area, or is caused by an act of terrorism or war, and results in the deaths of six or more persons within 30 days after onset of such an event, regardless of the cause, that causes damage to property of significant severity and magnitude4. Examples of natural catastrophic events are natural disasters, like floods, fires, earthquakes, droughts, tsunamis and epidemics4. Human-made catastrophic events are wars, explosions of factories, nuclear reactors, acts of terrorisms. All these events may aggravate the economic state of individuals, regions, and countries and specific restrictions of transport, housing, job loss, and hunger5.
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							The current COVID-19 pandemic is also an example of a natural disaster. The health burden is enormous, with more than 30 million cases worldwide, almost one milliondeaths, and more than 60 thousand patients in a critical state6. The restrictions related to social distancing have put a strain individuals, families, societies, and countries. Many aspects of daily life have been affected, resulting in stress, anxiety, and depression.
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							Anxiety is a feeling of worry, nervousness, or unease about something with an uncertain outcome, and it can co-exist or lead to depression7. The feeling of insecurity about any catastrophic event, including the COVID-19 pandemic, may lead to generalized anxiety disorder2. The available literature shows that pregnancy is especially prone to anxiety7,8. Furthermore, the prevalence of antenatal anxiety varies from 15 to 23%9, when worldwide, only 3-5% of the population suffers from anxiety symptoms3.
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							The relationship between anxiety and insecurity of pregnant women is highly probable10. Mental health has a crucial effect on maternal wellbeing and fetal development11. Therefore, it is necessary to look for early diagnosis and possible interventions in patients affected by the pandemic. 
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							We hope that analyzing previous natural disasters will help us better understand this relationship and plan studies and interventions among pregnant women affected by the COVID-19 pandemic worldwide. 
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							Aim of the study: To investigate the impact of anxiety on mental health in a population of pregnant women exposed to catastrophic events compared to healthy pregnant women without such exposure. 
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							Review Question
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							-How stress and insecurity related to the natural disaster impacted the anxiety of pregnant women?
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							PopulationInterventionComparisonOutcome  Pregnant women    Exposure to natural disaster or another catastrophic event    Pregnant women, in time without catastrophic
  events    Assessment of the anxiety of pregnant women and
  their attitude to the problematic situation   
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PopulationInterventionComparisonOutcome  Pregnant women    Exposure to natural disaster or another catastrophic event    Pregnant women, in time without catastrophic
  events    Assessment of the anxiety of pregnant women and
  their attitude to the problematic situation
?. [METHODS]
Study selection
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							Searching databases
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							    Pubmed / MEDLINE,     Web of Science,     Cochrane Library,    EMBASE,    Google Scholar.Search strategy
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							The results will be assessed manually without using any Search software. The general search phrase is shown in Table 2. Search engine options will be used to limit the search to title and abstract, languages restricted to English, German or Polish, no publication time limits.
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							  (pregnant OR pregnancy
  OR partum OR prepartum OR prenatal OR gestation OR partus OR prelabour OR
  maternal) AND ("catastrophic event" OR epidemic OR pandemic OR
  COVID-19 OR SARS-COV 2 OR "natural disaster" OR cataclysm OR
  explosion OR flood OR fire OR earthquake OR tsunami OR war OR "economic
  state" OR job loss OR hunger OR drought OR bomb) AND (anxiety OR mental)  
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							Inclusion criteria
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							Types of studies:
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							All types of evaluative study designs are eligible for inclusion, including grey literature. Studies will not be selected based on methodological quality.
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							Types of participants
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							This literature review will compare the prevalence of anxiety among pregnant women during a catastrophic event and pregnant women with pregnancy studied in a naturally stable setting. 
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							Types of exposure: 
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							Exposure to natural disasters or other catastrophic events onmaternalanxiety.
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							Types of outcome measures:
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							Assessment of anxiety of pregnant women during a catastrophic event. We expect that different scales to measure anxiety will be used. Therefore, a direct comparison will not be possible. Only a few used scales were evaluated for use in the pregnant women population by ICD-10 (10th revision of the International Statistical Classification of Diseases and Related Health Problems)12 or DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)13,14 guidelines. Regarding the method of anxiety evaluation, only studies using STAI (State-Trait Anxiety Inventory), GAD-2/7 (Generalised Anxiety Disorder scale)15,16, EPDS (Edinburgh Postnatal Depression Scale – Anxiety subscale)17, HADS (Hospital Anxiety and Depression Scale) – Anxiety subscale18, BMWS (Brief Measure of Worry Severity)19, CWS (Cambridge Worry Scale)20, W-DEQ – Version A (Wijma Delivery Expectancy/Experience Questionnaire)21, PRAQ-R (Pregnancy-Related Anxiety Questionnaire-Revised)22 would be included into the study9. The results published based on these studies will be assessed according to DSM-5 criteria and ICD-10 criteria. The effects of maternal anxiety will be divided into four groups: 0-none, 1-mild, 2 – moderate, and 3- severe anxiety.
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							Exclusion criteria 
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							Editorials, newspaper articles, and other forms of popular media will be excluded. Failure to meet any one of the above eligibility criteria will result in exclusion from the review, and an independent reviewer will resolve any apparent discrepancies resulting from the selection process. The main reason for exclusion will be incorrect anxiety measurement. The number of excluded studies (including reasons for exclusion for those excluded following review of the full text) will be recorded at each stage.
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							Patient and Public Involvement:
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							No patients involved
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(pregnant OR pregnancy
  OR partum OR prepartum OR prenatal OR gestation OR partus OR prelabour OR
  maternal) AND ("catastrophic event" OR epidemic OR pandemic OR
  COVID-19 OR SARS-COV 2 OR "natural disaster" OR cataclysm OR
  explosion OR flood OR fire OR earthquake OR tsunami OR war OR "economic
  state" OR job loss OR hunger OR drought OR bomb) AND (anxiety OR mental)
?. [ASSESSMENT OF RISK OF BIAS AND DATA EXTRACTION]
The risk of bias will be assessed independently during the data extraction process by at least two researchers using the Newcastle-Ottawa Scale. The third reviewer will determine any differences. Data on the prevalence and severity of anxiety will be extracted.
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							Each study will be assessed and compared in three aspects:
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							The selection of the study group and the control groupThe comparability of the groupsThe detection of the exposureA study will reach one star for each signaling question. The questions will be divided into three categories: Selection, Comparability, and Exposure/Outcome. Out of 9 possible stars, reaching 7 or more will be evaluated as a high-quality study.Studies will be divided into three categories: low risk of bias, unclear bias, and high risk of bias. The following characteristics will be evaluated:Random sequence generation (selection bias)Allocation concealment (selection bias)Incomplete results (attrition bias)Selective reporting (reporting bias)Other biasesA study will reach one star for each signaling question. The questions will be divided into three categories: Selection, Comparability, and Exposure/Outcome. Out of 9 possible stars, reaching 7 or more will be evaluated as a high-quality study.
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							Studies will be divided into three categories: low risk of bias, unclear bias, and high risk of bias. The following characteristics will be evaluated:
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							Random sequence generation (selection bias)Allocation concealment (selection bias)Incomplete results (attrition bias)Selective reporting (reporting bias)Other biases
?. [ASSESSMENT OF RISK OF BIAS AND DATA EXTRACTION]
?. [HETEROGENEITY AND REPORTING BIAS]
In case of severe methodological, clinical, or statistical heterogeneity, pooled results will not be reported. We will identify heterogeneity by both visual inspections of forest plots and statistical methods. Reporting bias will be determined by using funnel plots. 
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?. [ETHICS & DISSEMINATION]
A manuscript will be prepared for submission to a peer-reviewed journal. The current protocol is made using PRISMA-P guidelines and were registered in PROSPERO with ID-number: CRD42020178944.
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?. [RESULTS]
The authors suggest that the present study would lead to a better understanding of anxiety related to catastrophic events during pregnancy. Appropriate recommendations for the perinatal period are needed to improve maternal and neonatal outcomes.
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?. [DISCUSSION]
Nowadays, the mental health of pregnant women is an important aspect of perinatal care. Medical care providers' primary interest is maternal depression, but perinatal anxiety is also a significant health problem that could lead to adverse outcomes during pregnancy and depression. The COVID-19 pandemic may have a profound impact on mental health worldwide23. Crucial seems to be the fact that attention on the mental health of pregnant women is in the center of doctors' discussions. Since the beginning of the pandemic state worldwide (March 2020), several studies have been published. In the last four months, considerable attention is paid to the general mental health of the population. Pregnant women seem to be more attached to anxiety and the present situation seems to make it worth it. The reason for that fact is double worry because they self and the unborn fetuses. In September 2020, there are 15 studies about the influence of COVID-19 on pregnant women's mental health worldwide. The researches from Poland24, Hong Kong24, Iran25,26, China27–29, Turkey30,31, India32, Canada33, Israel34,35, UK36, Qatarare37, Ireland37,38. Moreover, Japan39 is studying anxiety among pregnant women during the COVID-19 pandemic. The worldwide interests of the current situation highlight the need for this systematic review. Comparing present COVID-related studies between each other and to other catastrophic events would customize the perinatal medical care.
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?. [CONCLUSION]
We hope that analyzing previous natural disasters will help us better understand this relationship and plan studies and interventions among pregnant women affected by the COVID-19 pandemic.
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?. [OTHER INFORMATION]
Authors’ contributions: SF:Conceptualization, Investigation, Methodology, Project Administration; Writing – Original Draft Preparation JM: Conceptualization, Investigation, Methodology, Writing – Original Draft Preparation; DS: Conceptualization, Investigation, Project Administration, Writing – Original Draft Preparation; SK: Conceptualization, Investigation, Methodology, Writing – Review & Editing; AK:Conceptualization, Investigation, Methodology, Supervision, Writing – Review & Editing
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							Funding: This study has received no funding.
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							Competing interests statement: None
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