COVID-19NCT04385238
Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic
An observational study of COVID-19 and Pregnancy Complications, run by Pregistry at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- COVID-19, Pregnancy Complications, Mental Health Wellness 1
- How many people
- 6,894 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 20 Jun 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women or women who have been pregnant in the last 6 months.
Who may be able to join
- Pregnant women or women who have been pregnant within the last 6 months
- Able to give electronic informed consent
Who cannot join
- <18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COVID-19, Pregnancy Complications, Mental Health Wellness 1, Anxiety, Depression, Ptsd
- Being tested
- This is an online survey with no intervention.
- Medical subject headings
- COVID-19, Pregnancy Complications, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an online survey with no intervention.Other
As this is an online survey about health and wellbeing, there is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Pregnant women who are 18 years of age or older. Receives: Other: This is an online survey with no intervention. | |
| Post-partum women | Women who gave birth within the last 6 months who are 18 years of age or older. Receives: Other: This is an online survey with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Anytime during pregnancy or within 6 months after given birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start15 May 2020
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6,894 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pregistry
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
- Investigators
- Karestan Koenen, PhD, Principal investigator, Department of Epidemiology, Harvard T.H. Chan School of Public HealthSonia Hernandez-Diaz, MD, DrPh, Study director, Department of Epidemiology, Harvard T.H. Chan School of Public HealthDiego Wyszynski, MD, MHS, PhD, Study director, Pregistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385238
- Sponsor's protocol ID
- 0002
- Status last verified
- Jan 2021
- First submitted
- 10 May 2020
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04385238
- Acronym / sponsor ID
- 0002
- Conditions
- COVID-19, Pregnancy Complications, Mental Health Wellness 1, Anxiety, Depression, Ptsd
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,894 participants (actual)
- Lead sponsor
- PregistryIndustry (pharma, biotech, devices)
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- 15 May 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Posted 7 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Other: This is an online survey with no intervention.Pregnant women who are 18 years of age or older. |
| Post-partum women | – | Other: This is an online survey with no intervention.Women who gave birth within the last 6 months who are 18 years of age or older. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women or women who have been pregnant in the last 6 months.
Key inclusion criteria (2 listed)
- Pregnant women or women who have been pregnant within the last 6 months
- Able to give electronic informed consent
Key exclusion criteria (1 listed)
- <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an online survey with no intervention.As this is an online survey about health and wellbeing, there is no intervention. | Other | Post-partum women, Pregnant Women |
Primary outcome
Number of Participants With Symptoms of Post-traumatic Stress Disorder
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Survey Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 PandemicLink provided by the sponsor.
- International Registry of Coronavirus Exposure in Pregnancy (IRCEP)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karestan Koenen, PhD principal investigator
Department of Epidemiology, Harvard T.H. Chan School of Public Health
Sonia Hernandez-Diaz, MD, DrPh study director
Department of Epidemiology, Harvard T.H. Chan School of Public Health
Diego Wyszynski, MD, MHS, PhD study director
Pregistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Pregnancy Complications, run by Pregistry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Symptoms of Post-traumatic Stress Disorder (time frame: Anytime during pregnancy or within 6 months after given birth.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.