Delivery During Covid-19 Pandemic: Implications for Obste... | NCT04609501

Studies
Delivery During Covid-19 Pandemic: Implications for Obstetrics, Maternal Psychopathology, and Mother-Infant Relationship

NCT04609501

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Jun 23, 2022Actual

Enrollment

440Actual

Phase

Not provided

Conditions

Delivery; Trauma
Covid19

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Oct 22, 2020

First Submission Date that Met QC Criteria

Oct 29, 2020

First Posted Date

Oct 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2022

Last Update Posted Date

Jun 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This is a multicenter prospective cohort study of childbearing women during COVID-19. Participants completed a comprehensive online questionnaire including demographic, socioeconomic, obstetric, and postnatal mental-health questionnaires. Data were verified with each center's perinatal database and information regarding physiological stress during pregnancy/birth was also collected. Fear of COVID-19 was evaluated using the validated Fear of COVID-19 Scale and postnatal depression was evaluated using the EPDS. Pre-existing maternal disability was defined as prior physiological or psychological chronic health condition.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

440Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women after delivery

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

women who delivered during the Covid-19 pandemic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rinat Gabbay-Benziv, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided