Characteristics of COVID-19 Infection Among PREGnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Asymptomatic COVID-19 positive pregnant women
研究概览
简要总结
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.
详细描述
TITLE: Characteristics of COVID-19 infection in pregnant women (CCOVID-PREG)
Background Coronavirus disease 2019 (COVID-19) is an infectious disease characterized by severe respiratory illness which can lead to multi-organ damage. It was reported in December 2019 in China, and was declared as a pandemic on March 11, 2020. The number of cases quickly increased in the USA since March; as of May 5th the total number of cases was 1'171,510 with 68,279 deaths.
COVID-19 is mainly spread through respiratory droplets of infected persons. While most respiratory viruses are more infectious when a patient is symptomatic, viral, epidemiology and modeling evidence suggest that also pre-symptomatic and asymptomatic individuals are able to transmit the infection. This information has implications on how resources can be spent on public interventions to prevent spreading of the virus. It also can help guide further management of pregnant women before, at, and after delivery.
Despite a recent publication reporting near 20% rate of positive COVID-19 tests in all pregnant women with a 13% rate of asymptomatic patients admitted to Labor and Delivery, the Society for Maternal Fetal Medicine and the Center for Disease Control and Prevention (CDC) still recommend not prioritizing testing of patients who are asymptomatic. Meanwhile, the American College of Obstetricians and Gynecologists published a recent Practice Advisory that encouraged prioritization of symptomatic patients but also acknowledges the potential impact of asymptomatic patients.
Racial disparities have been reported among non-pregnant adults infected with COVID-19. Lower income communities in New York City have a higher rate of infection, with Black and Hispanic communities found to be twice more likely to die from the infection as compared to Caucasians. Hispanic individuals are 1.7 more likely to get infected compared to their non-Hispanic peers. As many individuals in these communities are essential workers such as city employees and service personnel, many are undocumented; this is why public health interventions such as home isolation, social distancing, and early testing might not be applicable to these populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 years-old
- •Pregnant women admitted to obstetric units (Labor and Delivery, Antepartum High Risk Pregnancy, pre-operative obstetric related surgeries as Cesarean or Cerclage) of Inova Health System hospitals
排除标准
- •Pregnant women not tested for COVID-19
结局指标
主要结局
Asymptomatic COVID-19 positive pregnant women
时间窗: Through completion of the study, an average of 1 year
Rate of asymptomatic pregnant women who test positive for COVID-19 at the time of hospital admission
次要结局
- Asymptomatic Hispanic COVID-19 positive pregnant women(Through completion of the study, an average of 1 year)
- Follow up of asymptomatic COVID-19 positive pregnant women(Through completion of the study, an average of 1 year)
- COVID-19 positive newborns(Through completion of the study, an average of 1 year)
- Severe COVID-19 disease in pregnant women(Through completion of the study, an average of 1 year)
研究者
Luis M. Gomez
Associate Professor
Inova Health Care Services