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临床试验/NCT04718220
NCT04718220已完成不适用

Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 448 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
448
试验地点
2
主要终点
Rate of preterm delivery

研究概览

简要总结

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk preterm birth, cesarean section, and maternal critical care. This study will examine the factors that impede testing for SARS-CoV-2 (the causative virus among pregnant women), help determine optimal testing strategies by evaluating the necessity of testing for asymptomatic disease in pregnancy, inform prenatal care plans by assessing the full impact of infection, and contribute to a provider's ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.

详细描述

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk of preterm birth, cesarean section, and maternal intensive care. The objectives of this study are to: (a) evaluate the full impact of SARS-CoV-2 in pregnancy to inform testing strategies, (b) examine the factors that impede testing during pregnancy, and (c) use study data to devise implementation strategies that improve SARS-CoV-2 testing in pregnancy and prenatal care during the pandemic. Investigators will prospectively enroll two cohorts of pregnant women: 1) exposed (SARS-CoV-2 positive), and 2) unexposed (SARS-CoV-2 negative as defined by antibody testing at the beginning of pregnancy, every trimester, and at delivery). Women who initially enroll as unexposed but later test positive for SARS-CoV-2 antibodies will cross over to the exposed cohort. In Aim 1, investigators will evaluate patients' and providers' perceptions of SARS-CoV-2 testing during pregnancy and the influence of COVID-19 on maternal care-seeking behavior and anxiety via surveys and semi-structured interviews. In Aim 2, investigators will determine the effect of SARS-CoV-2 infection during pregnancy on the risk of preterm birth and other adverse pregnancy outcomes in symptomatic and asymptomatic disease. It is hypothesized that SARS-CoV-2 infection will increase the risk of preterm birth by 12%. In Aim 3, investigators will estimate the risk of mother-to-fetus SARS-CoV-2 transmission and viral presence in umbilical cord blood, placenta, and amniotic fluid by assaying for viral RNA in the neonate, cord blood, and placenta. Collectively, Aims 1-3 will be interpreted by investigators, the Scientific Advisory Board and the Community Advisory Board who will apply data to devising targeted implementation strategies designed for rapid community dissemination to improve testing and prenatal care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Rate of preterm delivery

时间窗: 20 weeks gestation until childbirth

Childbirth prior to 37 weeks of pregnancy, to be determined in accordance to standard pregnancy dating and the established estimated due date.

次要结局

  • Rate of preeclampsia(After 20 weeks gestation and up to 6 weeks postpartum)
  • Perinatal death(During the pregnancy after 20 weeks of pregnancy to 21 days after delivery)
  • Rate of fetal hydrops(Between conception and childbirth)
  • Rate of gestational hypertension(After 20 weeks gestation and up to 6 weeks postpartum)
  • Rate of cesarean section(Time of delivery)
  • Rate of stillbirth(Between 20 weeks gestation and childbirth)
  • Rate of fetal growth restriction(Between conception and childbirth)
  • Rate of neonatal sepsis(After delivery of newborn during delivery hospitalization up to 6 weeks of life)
  • Rate of oxygen therapy(After delivery of newborn during delivery hospitalization up to 6 weeks of life)
  • Percentage of infants with low 5-minute Apgar(At time of delivery)
  • Possible congenital infection(At time of delivery)
  • Rate of oligohydramnios(Between conception and childbirth)
  • Rate of premature preterm rupture of membranes(Between conception and 36 weeks 6 days of pregnancy)
  • Low birth weight(At time of delivery)
  • Confirmed congenital infection(Testing will be conducted at time of delivery.)
  • Rate of neonatal intensive care unit (NICU) admission(After delivery of newborn during delivery hospitalization)
  • Probable congenital infection(At time of delivery)
  • Percentage of infants with abnormal umbilical cord gas(At time of delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeannie Kelly

Assistant Professor

Washington University School of Medicine

研究点 (2)

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