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

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.

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Key information

Conditions

COVID-19 Anxiety Anxiety Disorders Behavior Behavioral Symptoms Coronaviridae Infections Coronavirus Coronavirus Infections Depression Female Urogenital Diseases and Pregnancy Complications Infections Lung Diseases Mental Disorders Mental Health Wellness 1 Nidovirales Infections PTSD Pneumonia Pneumonia, Viral Pregnancy Complications RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Pregistry

Los Angeles, California, 90045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

This is an online survey with no intervention.

Other

As this is an online survey about health and wellbeing, there is no intervention.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Pregistry

Industry

Collaborators

Harvard School of Public Health (HSPH)

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: May 12, 2020
Registry last updated: Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed