REGISTRO EPIDEMIOLOGICO DE COVID 19 EN GESTANTES
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- MATERNAL COMPLICATIONS
研究概览
简要总结
Study title Spanish Registry of Pregnant Women with COVID-19 Protocol number and version Number 55/20. Version V8. Sponsors This registry is a project promoted by Dr. Oscar Martínez Pérez of the Obstetrics and Gynaecology department of the Puerta de Hierro University Hospital.
Principal investigator of the registry National coordinator: Dr. Óscar Martínez Pérez. Obstetrics and Gynaecology Department. Puerta de Hierro University Hospital. Majadahonda.
Epidemiologist: Maria Luisa de la Cruz Conti Researchers for each site: 100 sites from 32 Spanish provinces are included (Appendix 1) Funding Neither the hospitals nor the participating investigators will receive any financial compensation for their collaboration. A bank account has been opened at the hospital's Biomedical Research Foundation to receive donations: COV20/00021 - SARS-COV-2 and the COVID-19 disease Call financed by the Carlos III Institute of Health and co-financed with ERDF funds.
Abstract Rationale: Knowledge about the impact of the SARS-CoV-2 virus on pregnancy is still scarce and all current recommendations are based on less than 100 cases published in the literature. To identify moderate effects (such as vertical transmission, obstetric morbidity, foetal death, maternal or neonatal death) and to allow accurate risk estimates, larger sample sizes than those currently available are required.
Methods: Prospective observational study of pregnant women in whom SARS-CoV-2 infection is suspected at any time during pregnancy with positive test results for SARS-CoV-2, in order to create a registry of baseline characteristics of the pregnant woman, aspects related to the course of pregnancy and delivery, and related to the new-born, with an observation period of up to 14 days after delivery. Subsequently, several phased studies will be conducted to help establish and monitor the set of measures to improve the care of pregnant women.
Discussion: The national registry for COVID-19 in pregnancy described here is a tool for sharing and centralizing data related to exposures to SARS-CoV-2 during pregnancy in a structured way. It should speed up the process of prospectively obtaining a large unbiased data set and will collect information at national level.
详细描述
Rationale To date, few studies have described the impact of the SARS-CoV-2 virus on pregnancy, particularly infection occurring during the third trimester of pregnancy. The impact of the virus during the first and second trimesters of pregnancy remains unknown and must be urgently determined. All current recommendations are based on less than 50 cases published in the literature, with speculations on different aspects of management. To identify moderate effects (such as vertical transmission, foetal death, maternal or neonatal death), larger sample sizes than those currently available are required to allow accurate risk estimates. The national registry for COVID-19 in pregnancy described here is a tool for sharing and centralizing data related to exposures to SARS-CoV-2 during pregnancy in a structured way. It should speed up the process of prospectively obtaining a large unbiased data set and will collect information at national level.
Study hypothesis and objectives Hypothesis The COVID 19 disease affects pregnancy and has an influence on maternal and perinatal morbidity and mortality Objectives This study focuses on the creation of a registry of pregnant women with COVID-19 infection, which will help establish and monitor the set of measures to improve their care.
Primary objective Collect and analyse COVID-19 cases in pregnant and postpartum women at associated health centres.
Secondary objectives
- Establish incidence of COVID-19 infections diagnosed in pregnant women in the Spanish population.
- Determine the variables that are associated with more maternal and neonatal morbidity.
- Determine if there is vertical transmission.
- Evaluate the risk of SARS-CoV-2 infection during pregnancy.
- Characterize the clinical course of SARS-CoV-2 infection during pregnancy (for example, severity of maternal symptoms, distribution of gestational age at onset, ICU admission, mechanical ventilation, death).
- Quantify the risk of adverse pregnancy outcomes (e.g., miscarriage, stillbirth, growth restriction) and neonatal outcomes (e.g., NICU, prematurity, death, birth defects).
- Identify additional risk factors and risk modifiers (e.g., symptomatic infection, SARS-CoV-2 positive amniotic fluid, co-infections).
- Develop a responsive data collection tool across a network of healthcare facilities to ensure rapid assessment of risks associated with future emerging pathogens and to help develop guidelines on this disease.
- Strengthen capacity-building in data exchange against emerging pathogens. The collected dataset will allow a comprehensive characterization of the risks associated with SARS-CoV-2 infection in pregnancy. In the future, the developed structure will allow a rapid assessment of the risks linked to future emerging pathogens.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients eligible for follow-up o target population will be any pregnant woman who is suspected or needs to be ruled out as having a SARS-CoV-2 infection at any time during pregnancy with positive test results for SARS-CoV-2 by PCR.
- •Information regarding each pregnant woman's demographic characteristics, comorbidities and current obstetric history was extracted from the medical history and the patient interview; subsequently, age and race were categorized according to the classification used by the Center for Disease Control and Prevention (CDC) (17).
- •For the selection of the control group to be collected in the same database, patients with a negative COVID-19 delivery diagnosed by PCR screening at delivery, or less than 3 days before, were considered.
- •Exclusion criteria
- •Pregnant women under the following conditions will be excluded from the registry:
- •Inability to give informed consent in the absence of a legal representative.
- •If, in the opinion of the researcher, findings in the physical examination, anomalies in the results of the laboratory tests or other medical, social or psychosocial factors could have a negative influence.
- •Loss of follow-up data prior to 6 weeks postpartum.
排除标准
- 未提供
结局指标
主要结局
MATERNAL COMPLICATIONS
时间窗: 1 year
MATERNAL MORTALITY MORBIDITY
NEONATAL INFECTION
时间窗: 1 year
VERTICAL TRANSMISION
次要结局
未报告次要终点
研究者
Oscar Martinez Perez
Obstetric senior consultant
Puerta de Hierro University Hospital