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Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385238
Recruitment Status : Completed
First Posted : May 12, 2020
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Pregistry

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
COVID-19 Pregnancy Complications Mental Health Wellness 1 Anxiety Depression Ptsd Coronavirus Other: This is an online survey with no intervention.

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.

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Study Type : Observational
Actual Enrollment : 7000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic
Actual Study Start Date : May 15, 2020
Actual Primary Completion Date : June 20, 2020
Actual Study Completion Date : June 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Group/Cohort 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.




Primary Outcome Measures :
  1. 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).

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Persons assigned gender female at birth.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women or women who have been pregnant in the last 6 months.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385238


Locations
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United States, California
Pregistry
Los Angeles, California, United States, 90045
Sponsors and Collaborators
Pregistry
Harvard School of Public Health
Investigators
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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
Additional Information:
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Responsible Party: Pregistry
ClinicalTrials.gov Identifier: NCT04385238    
Other Study ID Numbers: 0002
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy Complications