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NCT04398264 · ClinicalTrials.gov registry record
Characteristics of COVID-19 Infection Among PREGnant Women
A clinical trial, sponsored by Inova Health Care Services.
- Completed
- Registry status
- 650
- Enrollment target
NCT04398264: Completed study, sponsored by Inova Health Care Services.
NCT04398264 is a clinical trial that has completed, run by Inova Health Care Services. The registered enrollment target is 650 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04398264 has completed, sponsored by Inova Health Care Services.
- COMPLETED
- Registry status
- 650 participants
- Enrollment target
Study Summary
In December 2019, Coronavirus infection (COVID-19) was identified as causing serious respiratory infection in humans. Initially COVID-19 was propagated by infected symptomatic individuals; currently the disease is disseminated by asymptomatic COVID-19 positive subjects. The prevalence of asymptomatic COVID-19 individuals is unknown. Due its physiologic immune suppression, pregnancy is a vulnerable time for severe respiratory infections including COVID-19. Limited information is available regarding the impact of COVID-19 in pregnancy and the prevalence and demographic profile of asymptomatic pregnant women. Despite reports of 15-20% positive COVID-19 tests in women admitted to Labor and Delivery, professional obstetric medical societies still recommend not prioritizing testing of patients who are asymptomatic. In the USA, COVID-19 symptomatic patients come predominantly from lower income, Black and Latino communities. No data are available on the rate and demographic distribution of asymptomatic positive COVID-19 pregnant women. To minimize the risk of inadvertent exposure asymptomatic individuals, recently our institution started COVID-19 testing in all admitted pregnant women. The investigators expect to gain knowledge on the impact of COVID-19 in pregnant women especially if asymptomatic and compare to other respiratory infections.
Primary Outcome
Rate of asymptomatic pregnant women who test positive for COVID-19 at the time of hospital admission
Interventions
- OTHER COVID-19 positive via testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2020-07-22 |
| Est. Completion | 2021-03-31 |
What the finished NCT04398264 record still lists
NCT04398264 is an observational study that tracks outcomes without assigning an intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which COVID-19 positive via testing is the first listed.
NCT04398264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04398264 about?
NCT04398264 is a clinical study titled "Characteristics of COVID-19 Infection Among PREGnant Women". In December 2019, Coronavirus infection (COVID-19) was identified as causing serious respiratory infection in humans. Initially COVID-19 was propagated by infected symptomatic individuals; currently the disease is disseminated by asymptomatic COVID-19 positive subjects. The prevalence of asymptomati...
What is the current status of trial NCT04398264?
This trial is currently completed. The enrollment target is 650 participants. The study started on 2020-07-22. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT04398264?
The interventions under investigation include: COVID-19 positive via testing (OTHER).
Who is sponsoring clinical trial NCT04398264?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
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