COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 Neonatal Infection
研究概览
简要总结
This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.
详细描述
This is a cohort study of pregnant women confirmed positive for SARS-CoV-2 infection. Data will be collected in Portuguese maternities that agreed to collaborate in this study.
Pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for SARS-CoV-2 RT PCR as part of a universal testing policy. Maternal demographic data (age, comorbidities, parity, smoking habits), COVID-19 related data (symptoms, diagnostic tests, therapy used and ICU admission), gestational age at SARS-CoV-2 confirmed infection, pregnancy outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal outcome (birthweight and Apgar score, RT PCR neonate results) and breastfeeding strategies will be evaluated.
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
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women infected with Sars-Cov-
- •Delivery at Portuguese maternities.
排除标准
- •RT PCR SARS-CoV-2 negative.
结局指标
主要结局
SARS-CoV-2 Neonatal Infection
时间窗: 7 days
Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
次要结局
- Perinatal mortality(35 weeks)
- ICU maternal admission(35 weeks)
- 5 minute Apgar Score < 7(1 day)
- Preterm labour(35 weeks)
- PPROM(35 weeks)
- Miscarriage(14 weeks)