Assessing the Safety of Pregnancy In the CoRonavirus pandEmic: a Nationwide Prospective Study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Corona Virus Infection
- 发起方
- University of California, San Francisco
- 入组人数
- 7965
- 试验地点
- 1
- 主要终点
- Incidence of SARS-CoV-2 infection throughout pregnancy in women
- 状态
- 进行中（未招募）
- 最后更新
- 11个月前
概览
简要总结
Prospective nationwide cohort study of pregnant women enrolled early in gestation and followed for Covid-19 exposure and infection, with follow up of obstetrical outcomes and infant development through the first year of life.
详细描述
ASPIRE is focused on the first trimester, a critical and vulnerable period when all of a baby's organ systems form and the placenta - the crucial connection between mom and baby - develops. Currently, there are no data about the effects of COVID-19 infections in the first trimester. The study will provide critical information to: 1. Guide the care of pregnant women 2. Protect the safety of their babies and families 3. Help those considering pregnancy in the future understand what it means to be pregnant in this new era The investigators are recruiting 10,000 women from the start of pregnancy and will track COVID-19 exposures using frequent serology testing. The investigators will collect information during and after the pregnancy to try to determine the effects of COVID 19 for mom and baby. Participants will be asked to do the following throughout pregnancy: * Submit frequent, quick (\<1 minute each) symptom tracking reports using your mobile phone and/or computer. * Collect finger-stick blood samples from home at several points throughout your pregnancy. * Give permission to review medical records related to your pregnancy, delivery and baby's development. * Complete questionnaires online about your health during your pregnancy and after delivery of your baby.
研究者
入排标准
入选标准
- •Over age 18
- •Participant is 4-10 weeks pregnant (gestation)
排除标准
- •Male (biologically unable to achieve pregnancy)
结局指标
主要结局
Incidence of SARS-CoV-2 infection throughout pregnancy in women
时间窗: Up to 9 months
Determine the incidence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.
Prevalence of SARS-CoV-2 infection throughout pregnancy in women
时间窗: Up to 9 months
Determine the prevalence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.
次要结局
- Clinical, behavioral, and sociodemographic determinants(Up to 27 months)
- Risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women(Up to 1.5 years)
- Risk ratios of adverse obstetric in women infect with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women(Up to 9 months)