Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia

Postpartum Depression Clinical Trial

Official title:

Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437342
• Other study ID #: Covid-19 Postpartum depression
• Status: Completed
• Start date: June 30, 2020
• Est. completion date: October 27, 2020

Study information

• Verified date: October 2020
• Source: General and Maternity Hospital of Athens Elena Venizelou
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this multicenter prospective study is to evaluate the association between the Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic and anaesthesiologic variables

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: October 27, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All pregnant women over the age of 18 that present for labour (vaginal delivery or caesarean section)

Exclusion Criteria:

• Not eligible in writing and reading in Greek

• Drug abuse

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Maternal Distress
• Postpartum Depression
• Psychological Stress
• Stress, Psychological

Intervention

Other:
• PHQ-9 (Patient Health Questionnaire) Depression Scale
9 question questionnaire for assessment of depression
• GAD-7 (General Anxiety Disorder) scale
7 question questionnaire for assessment of General Anxiety Disorder
• 38 questions questionnaire
38 questions questionnaire
• EPDS (Edinburgh Postnatal Depression Scale)
10 questions scale for detection of postpartum depression

Locations

Country	Name	City	State
Greece	"Elena Venizelou" General and Maternity Hospital of Athens	Athens	Attica
Greece	Alexandra Genaral Hospital Athens	Athens
Greece	Aretaieio University Hospital	Athens	Attica
Greece	University of Ioannina Health Science	Ioannina
Greece	University of Ioannina, Medical School	Ioannina
Greece	University of Thessaly Medical School	Larisa

Sponsors (5)

Lead Sponsor	Collaborator
General and Maternity Hospital of Athens Elena Venizelou	Alexandra Hospital, Athens, Greece, Larissa University Hospital, National and Kapodistrian University of Athens, University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale)	Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)	40 days postpartum
Secondary	Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)	Association between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)	10 minutes postpartum
Secondary	Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain	Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)	2 minutes prior to discharge from the Postanaesthesia care unit
Secondary	Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain	Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)	2 minutes after admission to the Postanaesthesia care unit