Anxiety, Coronavirus, COVID-19, Depression, Mental Health Wellness 1, Pregnancy Complications, Ptsd
Conditions
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.
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.
Interventions
As this is an online survey about health and wellbeing, there is no intervention.
Sponsors
Harvard School of Public Health (HSPH)
Pregistry
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5,712 |
| 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. | 1,182 |
| Total | 6,894 |
Baseline characteristics
| Characteristic | Pregnant Women | Post-partum Women | Total |
|---|---|---|---|
| Age, Continuous | 31.2 years STANDARD_DEVIATION 4.1 | 31.7 years STANDARD_DEVIATION 4.9 | 31.3 years STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1288 Participants | 131 Participants | 1419 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4424 Participants | 1051 Participants | 5475 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 5712 Participants | 1182 Participants | 6894 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Anytime during pregnancy or within 6 months after given birth.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women | Number of Participants With Symptoms of Anxiety and Depression | 1200 Participants |
| Post-partum Women | Number of Participants With Symptoms of Anxiety and Depression | 438 Participants |
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).
Time frame: Anytime during pregnancy or within 6 months after given birth.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women | Number of Participants With Symptoms of Post-traumatic Stress Disorder | 1028 Participants |
| Post-partum Women | Number of Participants With Symptoms of Post-traumatic Stress Disorder | 532 Participants |