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| Name | Class |
|---|---|
| Harvard School of Public Health (HSPH) | OTHER |
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The purpose of this study is to assess the health and wellbeing of pregnant and recently pregnant women during the COVID-19 pandemic using an online survey.
Millions of women will give birth during the pandemic of Coronavirus Disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The consequences of COVID-19 for pregnant women and their offspring are unknown. This lack of information leads to anxiety among pregnant women, women who are considering getting pregnant, and their families. It is therefore important to assess the wellbeing and mental health of women during the COVID-19 pandemic.
The international nature of the online survey will allow the evaluation of how living during the COVID-19 pandemic affects pregnant and recently pregnant women at a global level, including the evaluation of potential cultural and geographic differences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women | Pregnant women who are 18 years of age or older. |
| |
| Post-partum women | Women who gave birth within the last 6 months who are 18 years of age or older. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is an online survey with no intervention. | Other | As this is an online survey about health and wellbeing, there is no intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Symptoms of Post-traumatic Stress Disorder | Post-traumatic Stress Disorder (PTSD) Symptoms will be assessed by the Impact of Events Scale-6. This scale includes a total of six items: two items from each of the three subscales of the measure, namely intrusion, hyperarousal and avoidance. Participants will be asked to report their PTSD symptoms in the past 7 days on a Likert Scale ranging from 0 (not at all) to 4 (extremely). | Anytime during pregnancy or within 6 months after given birth. |
| Number of Participants With Symptoms of Anxiety and Depression | Symptoms of anxiety and depression will be measured by the Patient Health Questionnaire-4 (PHQ-4) which combines two ultrabrief screeners: the PHQ-2 and the Generalised Anxiety Disorder Scale. Participants will be asked to report their symptoms of depression and anxiety in the past 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day) for a maximum score of 12. | Anytime during pregnancy or within 6 months after given birth. |
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Inclusion Criteria:
Exclusion Criteria:
Persons assigned gender female at birth.
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Pregnant women or women who have been pregnant in the last 6 months.
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| Name | Affiliation | Role |
|---|---|---|
| Karestan Koenen, PhD | Department of Epidemiology, Harvard T.H. Chan School of Public Health | Principal Investigator |
| Sonia Hernandez-Diaz, MD, DrPh | Department of Epidemiology, Harvard T.H. Chan School of Public Health | Study Director |
| Diego Wyszynski, MD, MHS, PhD | Pregistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pregistry | Los Angeles | California | 90045 | United States |
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| Label | URL |
|---|---|
| Survey Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic | View source |
| International Registry of Coronavirus Exposure in Pregnancy (IRCEP) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnant Women | Pregnant women who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention. |
| FG001 | Post-partum Women | Women who gave birth within the last 6 months who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant Women | Pregnant women who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention. |
| BG001 | Post-partum Women |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Symptoms of Post-traumatic Stress Disorder | Post-traumatic Stress Disorder (PTSD) Symptoms will be assessed by the Impact of Events Scale-6. This scale includes a total of six items: two items from each of the three subscales of the measure, namely intrusion, hyperarousal and avoidance. Participants will be asked to report their PTSD symptoms in the past 7 days on a Likert Scale ranging from 0 (not at all) to 4 (extremely). | Posted | Count of Participants | Participants | Anytime during pregnancy or within 6 months after given birth. |
|
This is a cross-sectional observational survey and, therefore, adverse event data were not collected.
This is a cross-sectional observational survey and, therefore, adverse event data were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnant Women | Pregnant women who are 18 years of age or older. This is an online survey with no intervention: As this is an online survey about health and wellbeing, there is no intervention and no assessment of adverse events. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sonia Hernandez-Diaz | Harvard T.H. Chan School of Public Health | 6174323942 | shernan@hsph.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 4, 2020 | Jan 1, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2020 | Jan 1, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011248 | Pregnancy Complications |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Women who gave birth within the last 6 months who are 18 years of age or older.
This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
Women who gave birth within the last 6 months who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention. |
|
|
| Primary | Number of Participants With Symptoms of Anxiety and Depression | Symptoms of anxiety and depression will be measured by the Patient Health Questionnaire-4 (PHQ-4) which combines two ultrabrief screeners: the PHQ-2 and the Generalised Anxiety Disorder Scale. Participants will be asked to report their symptoms of depression and anxiety in the past 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day) for a maximum score of 12. | Posted | Count of Participants | Participants | Anytime during pregnancy or within 6 months after given birth. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Post-partum Women | Women who gave birth within the last 6 months who are 18 years of age or older. This is an online survey with no intervention: As this is an online survey about health and wellbeing, there is no intervention and no assessment of adverse events. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |