NCT04629638

Brief Summary

Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in patients with covid-positive pregnancies in the 3rd month after birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 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

August 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

November 12, 2020

Last Update Submit

December 19, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Maternal attachment in SARS- cov2 positive and negative pregnant women

    Maternal attachment scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. High scores from the scale indicate high maternal attachment.

    3 months

  • Edinburgh depression scores in in SARS- cov2 positive and negative pregnant women

    Edinburgh depression scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. All questions are scored between 0 and 3 and the highest possible score on the scale is 30. and shows advanced depression.

    3 months

  • Postpartum anxiety scale scores in in SARS- cov2 positive and negative pregnant women

    Postpartum anxiety scale scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. It can be said that the postpartum anxiety levels of those who score 73 and below on the scale are low, those who score between 74 and 100 are medium, and those who score 101 and above are high.

    3 months

Study Arms (2)

covid -19 positive pregnant women

Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in 250 covid-positive pregnant women in the 3rd month after birth.

Other: Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores

covid -19 negative pregnant women

Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in 250 covid-negative pregnant women in the 3rd month after birth.

Other: Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores

Interventions

The results will be compared with the results of covid-negative pregnant women who gave birth in the same period.

covid -19 negative pregnant womencovid -19 positive pregnant women

Eligibility Criteria

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

Maternal attachment, edinburgh depression score and postpartum anxiety scale scores of 250 covid-19 positive pregnant women between the ages of 18-45 and 250 covid-negative pregnant women are compared.

You may qualify if:

  • covid -19 positive and negative pregnant women
  • have no psychiatric illness
  • not using antidepressants or antipsychotic drugs

You may not qualify if:

  • women with psychiatric illness
  • using antidepressants or antipsychotic drugs
  • not pregnant
  • adolescent pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

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

November 12, 2020

First Posted

November 16, 2020

Study Start

August 1, 2020

Primary Completion

November 15, 2020

Study Completion

November 20, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations