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临床试验/NCT04463758
NCT04463758已完成不适用

Covid-19 in Pregnancy: a French Population-based Cohort of Women and Newborns

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 6,015 人开始时间: 2020年5月11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
6,015
试验地点
1
主要终点
Joint evaluation of morbi-mortality for mother and child up to 12 weeks postpartum

研究概览

简要总结

The purpose of this study is to characterize the incidence and clinical features of the maternal COVID 19 infection, as well as the associated morbidity of the mother and the child, in the French context

详细描述

In the overall context of uncertainty about the morbidity associated with COVID-19 infection and its optimal management, knowledge is urgently required on infection during pregnancy.

First, pregnant women and newborns can have specific and severe reactions to infectious diseases, as seen in previous pandemics which justifies targeted surveillance. Second, optimal management must minimize the health risks of transmission to the newborn. While initial studies did not provide evidence for transmission in utero or during delivery, more recent data suggest that transmission is possible. The virus is present in vaginal secretions and stool, making vertical contamination possible during vaginal delivery. Similarly, transmission may occur during breastfeeding. These risks, which remain theoretical, must be weighed against known harmful consequences of mitigating strategies such as systematic caesarean (increase in maternal morbidity) and separating the child from the mother and contraindicating breastfeeding (negative impact on maternal-child bonding and optimal nutrition). In the absence of reliable data, some maternity hospitals have adopted a maximum precautionary principle, recommending caesarean for all COVID-19 positive women and imposing immediate mother-child separation after childbirth. These approaches are strongly debated in France. Third, optimal management of COVID-19 during pregnancy requires balancing maternal and newborn risks. Risks of maternal deterioration in the event of continuing pregnancy must be weighed against those to the child resulting from indicated preterm birth. This tradeoff is even more complex as evidence-based interventions to protect preterm infants, such as antenatal corticosteroid, may aggravate maternal infection. Finally, childbirth is not an elective procedure and requires managing large numbers of healthy women and newborns in a hospital setting where they are exposed to risks of infection.

Population-based research that captures the diversity of organizational structures and practices within maternity units is needed to guide management during the current epidemic and draw lessons for future infectious pandemics.

Principal innovative features are:

  • A population-based approach: Current data systems will include a limited number of pregnant women, principally from university hospitals with specific patient populations and management strategies. Because all maternity hospitals care for COVID-19+ pregnant women, a population-based approach is needed to calculate reliable incidence rates, assess practice variability and measure the impact of differences in management on maternal and newborn infection rates and health.
  • The inclusion of infected pregnant women who are not hospitalized and who recover before delivery will provide comprehensive data and measure early fetal in-utero exposure.
  • Immediate feedback to clinicians on their practices will inform current controversies about optimal management.
  • Joint follow-up of mother and child to 12 weeks after delivery, and longer if indicated, will document the medium-term impact of infection.
  • Inclusion of regions with time-varying exposure to the epidemic will provide information to evaluate public health policies.

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
否

入选标准

  • •Any woman with :
  • •either proven COVID-19 infection= positive PCR test, OR probable COVID-19 infection = typical clinical symptoms AND typical pulmonary radiology
  • •during pregnancy or within 42 days postpartum,
  • •whether or not this diagnosis is followed by hospitalization,

排除标准

  • •Refusal to participate
  • •Major protected (curator, trusteeship)

结局指标

主要结局

Joint evaluation of morbi-mortality for mother and child up to 12 weeks postpartum

时间窗: At12 weeks after delivery

Maternal Criterion: Validated Composite Criterion of Severe Maternal Morbidity (Epimoms study ref 7). Neonatal Criterion: Mortality and Composite Criterion of Severe Neonatal Morbidity Perinatal asphyxia (arterial pH to cord-7.15 and/or an excess base - 10mmol/L and/or lactates-6 mmol/L, Apgar score at 5 minutes -7), neonatal encephalopathy, seizures, intraventricular hemorrhage, cerebral infarction, periventricular leucomalacia, ulcerative enterocolite, sepsis, respiratory distress syndrome, bronchopulmonary dysplasia, central catheter, ventilatory support, transfusion

次要结局

  • Severe neonatal morbidity(Until 12 weeks after delivery)
  • Severe forms of COVID-19 infection in the mother(Until 12 weeks after delivery)
  • Number of women infection COVID-19(During pregnancy and up to 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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