NCT04647994Unknown不适用
Exploratory Study in COVID-19 During Pregnancy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Diagnostic test: SARS-CoV-2 serology
研究概览
简要总结
The SARS-CoV-2 infection may behave differently in pregnant and postpartum women in the short and long term. Several risk factors or medication use can interfere on disease' evolution and vertical transmission. Thus, due the current pandemic and the scarcity of scientific studies involving pregnant women with covid-19 or positive serology, combined with the need to elucidate the behavior of this viral infection in pregnant women in our population, this study aims to evaluate the clinical and laboratory evolution, transplacental passage, gestational and neonatal outcomes in pregnancies with positive SARS-CoV-2.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with clinical symptoms or positive serology for SARS-CoV-2 hospitalized or in delivery time;
- •Asymptomatic pregnant women for SARS-CoV-2 during pregnancy and hospitalized for delivery at HU-USP.
- •Pregnant women diagnosed with SARS-CoV-2 prior to delivery and who, after the quarantine period, followed prenatal care and delivered at the HU-USP or HCFMUSP.
排除标准
- •Non-confirmation of maternal SARS-CoV-2 infection in pregnant women hospitalized or in delivery time.
- •Withdrawal of pregnant woman to continue in the study.
结局指标
主要结局
Diagnostic test: SARS-CoV-2 serology
时间窗: 01/07/2021
Number of pregnant women with COVID-19 infection assessed with a serology test
次要结局
- Laboratorial analysis of maternal and umbilical cord blood(01/07/2021)
- Placental insufficiency ultrasound(01/07/2021)
- Newborn weight(01/07/2021)
- Laboratorial analysis of Amniotic Fluid(01/07/2021)
- Placenta biopsy(01/07/2021)
- Ovarian remains biopsy(01/07/2021)
- Anxious and depressive symptoms - HAD questionnaire(01/07/2021)
- PCR analysis(01/07/2021)
- Fetal morphology ultrasound(01/07/2021)
- Gestational age at delivery(01/07/2021)
- Laboratorial analysis of colostrum(01/07/2021)
- Laboratorial analysis of thyroid hormones(01/07/2021)
- Type of delivery(01/07/2021)
- Apgar score(01/07/2021)
- Use of mechanical ventilation(01/07/2021)
- Heart rate variability electrocardiogram(01/07/2021)
- Blood count analysis(01/07/2021)
- Laboratorial analysis of Interleukins(01/07/2021)
- Fatigue Scale(01/07/2021)
- Prone Position(01/07/2021)
- Laboratorial analysis of glycated hemoglobin(01/07/2021)
- Pulmonary Ultrasound(01/07/2021)
- Chest Tomography(01/07/2021)
研究者
研究点 (1)
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