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Clinical Trials/NCT04385238
NCT04385238
Completed
N/A

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

Pregistry1 site in 1 country6,894 target enrollmentMay 15, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
COVID-19
Sponsor
Pregistry
Enrollment
6894
Locations
1
Primary Endpoint
Number of Participants With Symptoms of Anxiety and Depression
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2020
End Date
June 20, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Pregistry
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.

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).

Study Sites (1)

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