WHO (World Health Organization) announced a pandemic state on 12 March 2020 due to COVID-19 related mortality and morbidity, and the rapid spread of the virus worldwide. As a result of the announcement, but also prior to the announcement, governments worldwide implemented measures to avoid further spread of the virus and reduce the number of causalities. Because of the pandemic, many essential services that usually make life easier, like banking, shopping facilities, all kinds of services, including medical, childcare, schools, sports and entertainment, are unavailable due to new regulations. This has severely impacted many aspects of everyday lives, causing many burdens, leading to fear, anxiety and uncertainty about the future and what it will bring. Many people are asking themselves questions such as: “How long will all this last?”, “How will it impact my life in the long-term?”, “Will I have a job when this is over?”, “Will I have an employer to return to?”, “Will all my family members survive?” and many more. Isolation and social distancing are important risk factors of mental health.
As the COVID-19 pandemic has a great impact on many aspects of everyday life, healthcare providers worldwide are concerned about the mental well-being of pregnant women. To better understand the current situation and to plan effective ways of helping, an International Group of Researchers “PregMIND” have come together to try to address this problem. If you are currently pregnant and would like to help us better understand your worries and concerns regarding daily life during the COVID pandemic, we invite you to fill out an anonymous survey.
This study has been an internationally coordinated effort within a short period of time. In order to ensure timeliness of this study, the research teams have translated all the questionnaires as efficiently and accurately as possible, however, some errors may persist. We apologise for any errors and mistakes that you may have identified, please contact the appropriate research team.
Title of the Research Project:
Risk factors for anxiety and depression among pregnant women during the COVID-19 pandemic.
This survey study has been approved by the Centre of Postgraduate Medical Education Research Ethics Committee (Decision No. 56/PB/2020).
Sonia Hassan, MD
Associate Vice President, Office of Women’s Health Professor,
Division of Maternal-Fetal Medicine,
Department of Obstetrics and Gynecology 3990 John R, Box 4, Detroit, 48201
Executive Assistant to Sonia S. Hassan, M.D.
Associate Vice President Wayne State University
Office of Women’s Health 6135 Woodward Ave, Detroit, MI 48202
Phone: (313) 577- 5774
Sarah Homitsky, MD
Medical Director, Women’s Behavioral Health
Department of Psychiatry, Allegheny Health Network
West Penn Hospital, Mellon Pavilion, M02
Office phone: 412-578-4031
Allegheny Health Network:
Hannah Makarevich, clinical research coordinator
Ashley Smith, research compliance specialist
Dinean Miller, clinical trial contract analyst
AIMS OF THE STUDY
The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, we will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.
It is a web-based anonymous survey of pregnant women living in countries affected by the COVID-19 pandemic. The survey is comprised of three sections: 1) questions related to general demography, pregnancy health history, mental health history, socioeconomic factors, as well as perception of fear, burden and restrictions related to the COVID-19 pandemic and 2) General Anxiety Disorder-7 (GAD-7) questionnaire for anxiety assessment and 3) Patient Health Questionnaire-9 (PHQ-9) for depression assessment. Web-based recruitment for health research has proven to be cost-effective and efficient. At current times with the COVID-19 pandemic, limited resources and social distancing restrictions, performing a mental health study involving pregnant women on a large international scale cannot be safely conducted without involving social-media.
The survey takes about 10-15 minutes to complete. Your participation in the survey is absolutely voluntary. All the answers you give will be kept entirely confidential as the survey is anonymous and we will not be able to identify you.
You have the right to withdraw your participation at any time before clicking the SUBMIT button at the end of the survey. To withdraw simply exit the page. None of the answers will be collected unless you click the SUBMIT button. This survey is anonymous. Anonymous means that once you submit your answers the research team will not be able to identify which data is yours and your data cannot be withdrawn.
By clicking the SUBMIT button at the end of the survey you are giving your consent to participate in the study. You are not waiving any of your legal rights as a research participant by consenting to participate in the study.
In this study you are being asked to complete an online survey as accurately as possible. The survey takes approximately 10-15 minutes to complete. The survey includes questions about demography, socioeconomic situation, general and mental health history, pregnancy risk assessment and specific aspects related to the COVID-19 pandemic. It also includes two standardized scales GAD-7 and PHQ-9 to assess your symptoms of anxiety and depression.
You may also choose to provide us with your name and contact details at the end of this survey if you are interested to participate in future studies. Your personal details will be collected separately and will not be linked to the information you have provided in the survey.
This study is being conducted by an international team of researchers. The aim is to better understand the aspects of pregnant women’s mental health during the COVID-19 pandemic. We have not received any funding and therefore are not able to compensate you in any form. We hope that your answers will help us to plan interventions for pregnant women during this worldwide public health crisis.
This survey is anonymous and the information provided cannot be linked back to you. Your Internet Protocol (IP) address will be collected by the survey tool but the research team will not have access to this information. There is a small risk of third party’s interference. A result of such interference the information that you provide in the survey could be traced back to you through your IP address. To minimise this risk this survey is hosted on a secure server at the St. Sophie’s Obstetrics and Gynaecology Hospital secure server. It is the same server that contains all the hospital’s patient information, so it is very secure.
Some questions in the survey ask about your current and prior mental health issues and your socioeconomic situation. Some questions may make you feel uncomfortable or upset and you may not want to answer them. You may skip the questions you do not want to answer or exit the survey and automatically withdraw your consent for participation in the study.
Data storage and protection:
Your privacy and confidentiality are very important to us and they will be protected throughout the study. All electronic data (the answers that you provide to the questions in the survey) will be stored on a password-protected computer in a locked room at the Department of Reproductive Health of the Centre of Postgraduate Medical Education located at the St. Sophie’s Specialist Obstetrics and Gynecological Hospital in Warsaw, Poland. Data will be stored in this location for 3 years before it is destroyed.
Questions and concerns relating to this research study could be addressed to Prof. Liona Poon, Department of Obstetrics and Gynaecology, Prince of Wales Hospital through email: email@example.com. If you have any further questions about your human rights in this research study, you can contact the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee at +852 3505 3935. The study is approved by the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (IRB/REC Reference Number: 2020.245).