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

January 5, 2021 updated by: Pregistry
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

6894

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90045
        • Pregistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women or women who have been pregnant in the last 6 months.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Anytime during pregnancy or within 6 months after given birth.
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.
Anytime during pregnancy or within 6 months after given birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pregistry

Collaborators

Harvard School of Public Health (HSPH)

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Actual)

June 20, 2020

Study Completion (Actual)

June 20, 2020

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on This is an online survey with no intervention.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe