NCT04384887

Brief Summary

In our study; Anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck Depression and Anxiety Score after the disease regressed are planned. (Beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. High score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms 17-29 points = moderate depressive symptoms 30-63 points = severe depressive symptoms

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 25, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2020

Completed
Last Updated

September 2, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 11, 2020

Last Update Submit

August 31, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of depression and anxiety score changes of covid-19 positive pregnants

    Evaluation of depression and anxiety score changes of covid-19 positive pregnants Pregnant women are questioned how this period was affected, as the pandemic period loaded with extra stress and caused depression and anxiety.

    4 months

Interventions

It is planned to receive pregnant women who are admitted to the clinic or outpatient clinic and who are offered inpatient follow-up and treatment with the diagnosis of COVID-19. Pregnant women who do not have covid-19 disease as a control group and who do not have a comorbid disease at similar gestational week will be included in the study. As a control group, covid-19 pcr negative patients will be admitted to our clinic in the same period.

Also known as: covid-19 negative pregnant women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women with a positive covid -19 pcr test between the ages of 18 and 45 will be included in the study and beck and anxiety tests will be performed 3 months after birth.

You may qualify if:

  • covid -19 pcr positive pregnant women
  • no psychiatric diagnosis no use of psychiatric medicine

You may not qualify if:

  • Non-pregnant patients, A psychiatric diagnosis use of psychiatric medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersDepression, Postpartum

Condition Hierarchy (Ancestors)

Mental DisordersPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 12, 2020

Study Start

April 25, 2020

Primary Completion

August 25, 2020

Study Completion

August 26, 2020

Last Updated

September 2, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

Locations