NCT04385238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,894

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 7, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

May 10, 2020

Results QC Date

November 1, 2020

Last Update Submit

January 5, 2021

Conditions

COVID-19Pregnancy ComplicationsMental Health Wellness 1AnxietyDepressionPtsdCoronavirus

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

Pregnant Women

Pregnant women who are 18 years of age or older.

Other: This is an online survey with 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.

Interventions

This is an online survey with no intervention.OTHER

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

Post-partum womenPregnant Women

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPersons assigned gender female at birth.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Pregnant women or women who have been pregnant within the last 6 months
  • Able to give electronic informed consent

You may not qualify if:

  • \<18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pregistry

Los Angeles, California, 90045, United States

Location

Related Links

MeSH Terms

Conditions

COVID-19Pregnancy ComplicationsAnxiety DisordersDepressionStress Disorders, Post-TraumaticCoronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMental DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related Disorders

Results Point of Contact

Title
Sonia Hernandez-Diaz
Organization
Harvard T.H. Chan School of Public Health
shernan@hsph.harvard.edu
6174323942

Study Officials

  • Karestan Koenen, PhD

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

    PRINCIPAL INVESTIGATOR

  • Sonia Hernandez-Diaz, MD, DrPh

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

    STUDY DIRECTOR

  • Diego Wyszynski, MD, MHS, PhD

    Pregistry

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2020

First Posted

May 12, 2020

Study Start

May 15, 2020

Primary Completion

June 20, 2020

Study Completion

June 20, 2020

Last Updated

January 7, 2021

Results First Posted

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)