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临床试验/NCT04913948
NCT04913948已完成不适用

Assessing the Mother-to-infant Transmission Capabilities of COVID-19 Infection Among Pregnant Women in Ontario, Canada

Ottawa Hospital Research Institute12 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2020年4月30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
246
试验地点
12
主要终点
Rate of Perinatal Transmission of SARS-CoV-2

研究概览

简要总结

In order to assess the mother-to-infant and potential vertical transmission of SARS-CoV-2 infection in pregnant women, maternal and neonatal biological samples were prospectively collected from women with confirmed or suspected COVID-19 at participating hospitals. Samples were be tested for the SARS-CoV-2 serology and presence of SARS-CoV-2 RNA.

Outcomes for the study objective will be ascertained through the collection and testing of biological samples from the mother and/or infant. Specifically the investigators will:

  1. Assess maternal nasopharyngeal or oropharyngeal swab, vaginal mucosa, ano-rectal swab, amniotic fluid, placenta (including subamniotic swab), breastmilk, cord blood and neonatal nasopharyngeal swab for RNA particles of coronavirus, by ddPCR.
  2. Assess maternal serum for anti-coronavirus antibodies, by immunoassay.
  3. Examine the impact of coronavirus on the neonate with respect to serology and viral load, in addition to placenta pathology findings and ddPCR.
  4. Assess vertical transmission and the effect of coronavirus through placental pathology examination using placental pathology synoptic report.

详细描述

Pregnant individuals with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection were more likely to experience greater disease severity and higher rates of hospitalization, intensive care unit (ICU) admission and death compared to their non-pregnant counterparts. Early pandemic data were limited to a few small case series and reports that failed to provide a clear understanding of the timing and likelihood of fetal/neonatal infection. Data now suggest that in utero, intrapartum and early postnatal transmission of SARS-CoV-2 to the fetus/neonate is rare (<5%) and predominantly associated with third trimester infections and severe disease presentation. A living systematic review and meta-analysis of 144 cohort studies found that the rate neonates/fetuses testing positive for SARS-CoV-2 by RT-PCR, having anti-SARS-CoV-2 IgM antibodies or both was 1.94% (95%CI 1.31%, 2.66%). However, tests for SARS-CoV-2 and anti-SARS-CoV-2 antibodies were limited during the earliest stages of the pandemic and relatively few of the included studies provided sufficient data on the timing of fetal/neonatal exposure, and the type and timing of tests performed.

Derivation of reliable risk estimates for perinatal transmission remains challenging due to significant heterogeneity across published studies regarding the types of tissues profiled, diagnostic methods used and availability of essential COVID-19 disease characteristics such as timing and severity of maternal infection. As variants of concern continue to emerge, more data are required to elucidate the circumstances in which SARS-CoV-2 infection is likely to be transmitted to the developing fetus/neonate. We sought to evaluate the rate of SARS-CoV-2 transmission from mother-to-neonate in a large multicenter cohort from Ontario and Quebec, Canada.

To address early pandemic challenges in characterizing perinatal infections, a prospective cohort study was conducted across 14 sites in Ontario and Quebec, Canada. Pregnant individuals who had received a diagnosis of SARS-CoV-2 infection in pregnancy were eligible. Sample collection at delivery included maternal samples (nasopharyngeal/oropharyngeal, vaginal and anorectal swabs; blood; breastmilk), newborn samples (nasopharyngeal swabs, cord blood, amniotic fluid), and placental samples (sub-amniotic swab, placental biopsies). Swab, amniotic fluid, placenta and breastmilk samples were analyzed for SARS-CoV-2 RNA by RT-qPCR. Blood, breastmilk and amniotic fluid were assessed for anti-SARS-CoV-2 spike (S), receptor binding domain (RBD) and nucleocapsid (N) IgG, IgM and IgA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women with confirmed COVID-19 at any point during pregnancy or suspected COVID-19 at time of delivery (as identified at local hospital) , who will be delivering at a participating hospital in Ontario or Quebec

排除标准

  • 未提供

结局指标

主要结局

Rate of Perinatal Transmission of SARS-CoV-2

时间窗: During the delivery admission

Evidence of SARS-CoV-2 RNA or antibodies against SARS-CoV-2 from a sterile (amniotic fluid) or non-sterile sample (nasopharyngeal swab sample, placental tissue, subamniotic swab or by cord blood serology \[for IgM or IgA\]) collected during the maternal hospital admission for delivery (specific time frame varied per participant).

Rate of Intrauterine Transmission of SARS-CoV-2

时间窗: During the delivery admission

Evidence of SARS-CoV-2 RNA or antibodies against SARS-CoV-2 in fetal tissues (i.e., amniotic fluid, placental tissue, sub-amniotic swab, cord blood) collected during maternal hospital admission for delivery (specific time frame varied per participant). Evidence of intrauterine transmission was determined using RT-PCR and serological analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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