Demographics and Outcomes of COVID 19 in Pregnancy at a C... | NCT04385914

Studies
Demographics and Outcomes of COVID 19 in Pregnancy at a Community Based Hospital

NCT04385914

Sponsor

Atlantic Health System

Status

Unknown status

Last Update Posted

May 13, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Corona Virus Infection

Interventions

COVID positive via testing

Countries

Not provided

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

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2020Estimated

Primary Completion Date

Sep 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

May 11, 2020

First Submission Date that Met QC Criteria

May 11, 2020

First Posted Date

May 13, 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

May 11, 2020

Last Update Posted Date

May 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Demographics of pregnant COVID persons under investigation and those who were positive from March-May 2020. Looking at demographics including age, socio-economic status and pregnancy outcomes in these groups.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID positive patients			Other: COVID positive via testing
COVID negative patients			Other: COVID positive via testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID positive via testing	Other	Following pregnancy outcomes whether they are COVID positive or negative	COVID negative patients COVID positive patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy Outcome	increased risk of preterm birth, preeclampsia, etc.	through study completion, approximately 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Currently pregnant, considered PUI or know COVID positive patient during pregnancy, and documentation of COVID symptoms within AHS.

Exclusion Criteria:

Not pregnant, No documentation of COVID-19 symptoms within AHS.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant females

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Pregnant patients who presented to AHS within March-May 2020

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samantha Collazo, MD	Contact	856-397-7788		samantha.collazo@atlantichealth.org

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided