NCT04609501

Brief Summary

The Coronavirus 2019 (COVID-19) pandemic has brought about unprecedented social, economic and mental-health challenges, especially for vulnerable populations such as pregnant and post-partum females. In this study, we aimed to evaluate the relations between the fear of COVID-19 and postnatal depression symptoms.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

3.1 years

First QC Date

October 22, 2020

Last Update Submit

June 22, 2022

Conditions

Delivery; TraumaCovid19

Outcome Measures

Primary Outcomes (2)

  • Evaluation of COVID-19 during pregnancy

    Fear of COVID-19 was evaluated using the validated Fear of COVID-19 Scale

    1 year after delivery

  • The relations between fear of COVID-19 and postnatal depression symptoms.

    Postnatal depression was evaluated using the EPDS.

    1 year after delivery

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen after delivery
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women who delivered during the Covid-19 pandemic

You may qualify if:

  • women who delivered during the Covid-19 pandemic at the site, since 01-March-2020

You may not qualify if:

  • women age 18 and below
  • Gestational age under 34 weeks
  • Intra Uterine Fetal Demise
  • Ante-partum Fetal Demise
  • Maternal post partum death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Wounds and InjuriesCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rinat Gabbay-Benziv, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 30, 2020

Study Start

June 1, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2024

Last Updated

June 23, 2022

Record last verified: 2022-06

Locations

IL(1)