Demographics and Outcomes of COVID 19 in Pregnancy at a Community Based Hospital
May 11, 2020 updated by: Farah Benarba, Atlantic Health System
Demographics and Outcomes of Pregnant COVID 19 Positive Women in a Community Health System
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant patients who presented to AHS within March-May 2020
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
COVID positive patients
|
Following pregnancy outcomes whether they are COVID positive or negative
|
|
COVID negative patients
|
Following pregnancy outcomes whether they are COVID positive or negative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnancy Outcome
Time Frame: through study completion, approximately 1 year
|
increased risk of preterm birth, preeclampsia, etc.
|
through study completion, approximately 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2020
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
May 11, 2020
First Submitted That Met QC Criteria
May 11, 2020
First Posted (Actual)
May 13, 2020
Study Record Updates
Last Update Posted (Actual)
May 13, 2020
Last Update Submitted That Met QC Criteria
May 11, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1595116-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.