Corona Virus InfectionNCT04385914
Demographics and Outcomes of COVID 19 in Pregnancy at a Community Based Hospital
An observational study of Corona Virus Infection, run by Atlantic Health System.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- COVID positive via testing
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant patients who presented to AHS within March-May 2020
Who may be able to join
- Currently pregnant, considered PUI or know COVID positive patient during pregnancy, and documentation of COVID symptoms within AHS.
Who cannot join
- Not pregnant, No documentation of COVID-19 symptoms within AHS.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Corona Virus Infection
- Being tested
- COVID positive via testing
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID positive via testingOther
Following pregnancy outcomes whether they are COVID positive or negative
| Study group | Role | What they receive |
|---|---|---|
| COVID positive patients | Not described Receives: Other: COVID positive via testing | |
| COVID negative patients | Not described Receives: Other: COVID positive via testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Outcome
increased risk of preterm birth, preeclampsia, etc.
Measured: through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study startMay 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Benarba, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385914
- Sponsor's protocol ID
- 1595116-1
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographics and Outcomes of Pregnant COVID 19 Positive Women in a Community Health System
- ClinicalTrials.gov ID
- NCT04385914
- Acronym / sponsor ID
- 1595116-1
- Conditions
- Corona Virus Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID positive patients | – | Other: COVID positive via testing |
| COVID negative patients | – | Other: COVID positive via testing |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant patients who presented to AHS within March-May 2020
Key inclusion criteria (1 listed)
- Currently pregnant, considered PUI or know COVID positive patient during pregnancy, and documentation of COVID symptoms within AHS.
Key exclusion criteria (1 listed)
- Not pregnant, No documentation of COVID-19 symptoms within AHS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID positive via testingFollowing pregnancy outcomes whether they are COVID positive or negative | Other | COVID negative patients, COVID positive patients |
Primary outcome
Pregnancy Outcome
Time frame: through study completion, approximately 1 year
increased risk of preterm birth, preeclampsia, etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection, run by Atlantic Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha Collazo, MD (856-397-7788, samantha.collazo@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Outcome (time frame: through study completion, approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.