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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385238
• Other study ID #: 0002
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: June 20, 2020

Study information

• Verified date: January 2021
• Source: Pregistry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6894
• Est. completion date: June 20, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Coronavirus
• COVID-19
• Depression
• Mental Health Wellness 1
• Pregnancy Complications
• Ptsd

Intervention

Other:
• This is an online survey with no intervention.
As this is an online survey about health and wellbeing, there is no intervention.

Locations

Country	Name	City	State
United States	Pregistry	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Pregistry	Harvard School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Anytime during pregnancy or within 6 months after given birth.
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.	Anytime during pregnancy or within 6 months after given birth.

External Links

•   International Registry of Coronavirus Exposure in Pregnancy (IRCEP)
•   Survey Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic