Trial document




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  DRKS00021208

Trial Description

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Title

COVID-19 related obstetric and neonatal outcome study (CRONOS)

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Trial Acronym

CRONOS

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Summary of project
A novel coronavirus, termed SARS-CoV-2 (or COVID-19), has rapidly spread across the globe creating a massive public health problem. It causes potentially a life-threatening respiratory distress disease. Previous epidemics of many emerging viral infections have typically resulted in poor obstetrical outcomes including maternal morbidity and mortality, maternal-fetal transmission of the virus, and perinatal infections and death. The available literature describes only 38 pregnant women with SARS-CoV-2 with no maternal death and no evidence for intrauterine or transplacental transmission of the virus to their fetuses.
The planned study is non-interventional prospective cohort study in order to overcome the lack of knowledge about epidemiology and clinical course of SARS-COV-2 in pregnant women to further develop evidence-based diagnostic and therapeutic recommendations. Data collection will be performed retrospectively after a pregnant patient case has been completed (treatment is finished or patient’s death). Recruitment will be bidirectional, including past patients, and prospective identification of patients with confirmed SARS-CoV-2 diagnosis. Only data from standard of care treatment will be collected (secondary data use). All data will be pseudonymised for anonymity from initial collection and entered to the online database https://castoredc.com.

At our study sites, we aim to recruit women admitted to hospital with confirmed SARS-CoV-2 in pregnancy.
This will allow for
1. the recognition of outcomes of COVID-19 infection in pregnancy for both mother and infant
2. the identification of characteristics of women who are hospitalised due to COVID-19/have a concomitant COVID-19 infection, and to determine whether these characteristics influence pregnancy and/or disease outcome

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Protocol, ethical approval, Database will be provided for all additional study centres. Statistical analysis is "work in progress" and will be provided via URL of DGPM-online.org once established

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Organizational Data

  •   DRKS00021208
  •   2020/03/31
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  •   yes
  •   Approved
  •   D 451/20, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   Medical history, clinical data of Covid-19 positive pregnant women will be collected during pregnancy, delivery, of the neonate and during childbed.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Trying to identify the risk/risk factors for bad outcome of Covid-19 infection during pregnancy for mother and baby until the end of the puerperium (6 weeks postpartum).

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Secondary Outcome

Time of infection in relation to critical illness of patient, risk factors, teratogenity, embryo toxicity, course of delivery, critical ill newborn, need for intensive care of mother/child, transmission of virus to baby, bonding and breastfeeding habits

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/04/03
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Proven Covid-19 infection during pregnancy and childbed

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Exclusion Criteria

deny of informed consent, withdrawal of informed consent

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Addresses

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    • Vorstand der Deutschen Gesellschaft für Perinatale Medizin (DGPM) e.V.c/o Conventus Congressmanagement & Marketing GmbH
    • Mr.  Privatdozent Dr. med.  Ulrich  Pecks 
    • Carl-Pulvrich-Str. 1
    • 07745  Jena
    • Germany
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    • Universitätsklinikum Schleswig-Holstein Campus Kiel Klinik für Gynäkologie und Geburtshilfe
    • Mr.  Privatdozent Dr. med.  Ulrich  Pecks 
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Deutsche Gesellschaft für Perinatale Medizinc/o Conventus Congressmanagement & Marketing GmbH
    • Mr.  Privatdozent Dr.  Ulrich  Pecks 
    • Carl-Pulvrich-Str. 1
    • 07745  Jena
    • Germany
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Sources of Monetary or Material Support

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    • im Auftrag der Deutschen Gesellschaft für Perinatale Medizin e.V.c/o Conventus Congressmanagement & Marketing GmbH
    • Mr.  Professor Dr. med.  Rolf  Schlößler 
    • Carl-Pulfrich-Str. 1
    • 07745  Jena
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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