Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pregnant Women Pregnant women who are 18 years of age or older. |
Other: This is an online survey with no intervention.
As this is an online survey about health and wellbeing, there is no intervention.
|
| Post-partum women Women who gave birth within the last 6 months who are 18 years of age or older. |
Other: This is an online survey with no intervention.
As this is an online survey about health and wellbeing, there is no intervention.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Symptoms of Post-traumatic Stress Disorder [Anytime during pregnancy or within 6 months after given birth.]
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).
- Number of Participants With Symptoms of Anxiety and Depression [Anytime during pregnancy or within 6 months after given birth.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pregnant women or women who have been pregnant within the last 6 months
-
Able to give electronic informed consent
Exclusion Criteria:
- <18 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pregistry | Los Angeles | California | United States | 90045 |
Sponsors and Collaborators
- Pregistry
- Harvard School of Public Health (HSPH)
Investigators
- Principal Investigator: Karestan Koenen, PhD, Department of Epidemiology, Harvard T.H. Chan School of Public Health
- Study Director: 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 Documents (Full-Text)
More Information
Additional Information:
- Survey Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic
- International Registry of Coronavirus Exposure in Pregnancy (IRCEP)
Publications
None provided.- 0002
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pregnant Women | Post-partum Women |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 5712 | 1182 |
| COMPLETED | 5712 | 1182 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Pregnant Women | Post-partum Women | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 5712 | 1182 | 6894 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
31.2
(4.1)
|
31.7
(4.9)
|
31.3
(4.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5712
100%
|
1182
100%
|
6894
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1288
22.5%
|
131
11.1%
|
1419
20.6%
|
| Not Hispanic or Latino |
4424
77.5%
|
1051
88.9%
|
5475
79.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Participants With Symptoms of Post-traumatic Stress Disorder |
|---|---|
| Description | 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). |
| Time Frame | Anytime during pregnancy or within 6 months after given birth. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pregnant Women | Post-partum Women |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 5712 | 1182 |
| Count of Participants [Participants] |
1028
18%
|
532
45%
|
| Title | Number of Participants With Symptoms of Anxiety and Depression |
|---|---|
| Description | 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. |
| Time Frame | Anytime during pregnancy or within 6 months after given birth. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pregnant Women | Post-partum Women |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 5712 | 1182 |
| Count of Participants [Participants] |
1200
21%
|
438
37.1%
|
Adverse Events
| Time Frame | This is a cross-sectional observational survey and, therefore, adverse event data were not collected. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | This is a cross-sectional observational survey and, therefore, adverse event data were not collected. | |||
| Arm/Group Title | Pregnant Women | Post-partum Women | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Pregnant Women | Post-partum Women | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Serious Adverse Events |
||||
| Pregnant Women | Post-partum Women | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Pregnant Women | Post-partum Women | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Sonia Hernandez-Diaz |
|---|---|
| Organization | Harvard T.H. Chan School of Public Health |
| Phone | 6174323942 |
| shernan@hsph.harvard.edu |
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