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

NCT ID: NCT04385238

Last Updated: 2021-01-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6894 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-06-20

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnant Women

Pregnant women who are 18 years of age or older.

This is an online survey with no intervention.

Intervention Type OTHER

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.

This is an online survey with no intervention.

Intervention Type OTHER

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

Interventions

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This is an online survey with no intervention.

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Pregistry

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karestan Koenen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Epidemiology, Harvard T.H. Chan School of Public Health

Sonia Hernandez-Diaz, MD, DrPh

Role: STUDY_DIRECTOR

Department of Epidemiology, Harvard T.H. Chan School of Public Health

Diego Wyszynski, MD, MHS, PhD

Role: STUDY_DIRECTOR

Pregistry

Locations

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Pregistry

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://survey.pregistry.com/

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

https://corona.pregistry.com

International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

Other Identifiers

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0002

Identifier Type: -

Identifier Source: org_study_id

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