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

Completed

• Conditions: Psychological Stress; Maternal Distress; Postpartum Depression
• Interventions: Other: PHQ-9 (Patient Health Questionnaire) Depression Scale; Other: GAD-7 (General Anxiety Disorder) scale; Other: 38 questions questionnaire; Other: EPDS (Edinburgh Postnatal Depression Scale)

• Registration Number: NCT04437342
• Lead Sponsor: General and Maternity Hospital of Athens Elena Venizelou

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Study Start: 2020-06-30
• Primary Completion: 2020-08-30
• Status Verified: 2020-10
• Study Completion: 2020-10-27
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 330

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Maternal Group	GAD-7 (General Anxiety Disorder) scale	Pregnant women in labour (vaginal delivery or caesarean section) that are admitted to the hospital. Pre-labour 3 different questionnaires are administered to evaluate depression, general anxiety disorder and the association to the covid-19 pandemic. 40 days post delivery via telephone contact 2 questionnaires are administered, one in order to assess the postpartum disorder the other to assess depression.
Maternal Group	EPDS (Edinburgh Postnatal Depression Scale)	Pregnant women in labour (vaginal delivery or caesarean section) that are admitted to the hospital. Pre-labour 3 different questionnaires are administered to evaluate depression, general anxiety disorder and the association to the covid-19 pandemic. 40 days post delivery via telephone contact 2 questionnaires are administered, one in order to assess the postpartum disorder the other to assess depression.
Maternal Group	38 questions questionnaire	Pregnant women in labour (vaginal delivery or caesarean section) that are admitted to the hospital. Pre-labour 3 different questionnaires are administered to evaluate depression, general anxiety disorder and the association to the covid-19 pandemic. 40 days post delivery via telephone contact 2 questionnaires are administered, one in order to assess the postpartum disorder the other to assess depression.
Maternal Group	PHQ-9 (Patient Health Questionnaire) Depression Scale	Pregnant women in labour (vaginal delivery or caesarean section) that are admitted to the hospital. Pre-labour 3 different questionnaires are administered to evaluate depression, general anxiety disorder and the association to the covid-19 pandemic. 40 days post delivery via telephone contact 2 questionnaires are administered, one in order to assess the postpartum disorder the other to assess depression.

Primary Outcome Measures

Name	Time	Method
Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale)	40 days postpartum	Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)

Secondary Outcome Measures

Name	Time	Method
Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)	10 minutes postpartum	Association between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)
Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain	2 minutes after admission to the Postanaesthesia care unit	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)

Trial Locations

Locations (6)

University of Ioannina, Medical School; 🇬🇷 Ioannina, Greece

"Elena Venizelou" General and Maternity Hospital of Athens; 🇬🇷 Athens, Attica, Greece

Alexandra Genaral Hospital Athens; 🇬🇷 Athens, Greece

University of Thessaly Medical School; 🇬🇷 Larisa, Greece

Aretaieio University Hospital; 🇬🇷 Athens, Attica, Greece

University of Ioannina Health Science; 🇬🇷 Ioannina, Greece