NCT04385914

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Status
unknown

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

May 1, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 11, 2020

Last Update Submit

May 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pregnancy Outcome

    increased risk of preterm birth, preeclampsia, etc.

    through study completion, approximately 1 year

Study Arms (2)

COVID positive patients

Other: COVID positive via testing

COVID negative patients

Other: COVID positive via testing

Interventions

Following pregnancy outcomes whether they are COVID positive or negative

COVID negative patientsCOVID positive patients

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant patients who presented to AHS within March-May 2020

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DO

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 13, 2020

Study Start

May 1, 2020

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share