Trial document




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  DRKS00022088

Trial Description

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Title

Prevalence of SARS-CoV-2 (COVID-19) in pregnancy and at delivery in Franconia, Germany

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Trial Acronym

SCENARIO

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URL of the Trial

http://www.covid19scenario.de

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Brief Summary in Lay Language

Aim of this trial is to determine the prevalence of SARS-CoV-2 virus and/or IgG-antibodies in pregnant women. Furthermore, pregnant women will be investigated for fetal and/or maternal morbidity during and after birth.

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Brief Summary in Scientific Language

Primary objective of this trial is the prevalence of acute SARS-CoV-2-Infection by RT-PCR and prevalence of SARS-CoV-2-specific IgG antibodies in pregnancy. Women with positive results will be monitored for maternal and fetal morbidities during pregnancy and after birth.

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

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00022088
  •   2020/06/03
  •   [---]*
  •   yes
  •   Approved
  •   185_20B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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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

  •   2400 pregnant women and 150 members of the hospital care team in the department of obstetrics. The observation period is three months.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Rate of seropositive pregnant women in pregnancy in three cohorts (1st month, 2nd month, 3rd month)

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Secondary Outcome

Time of SARS-CoV-2-Infection of mother and fetus/newborn
Complications in pregnancy
Mode and complications of delivery
Neonatal complications
Rate of seropositive members of the hospital care team in the department of obstetrics

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/06/02
  •   2550
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Age >= 18 yrs;
Written informed consent;
Pregnant women or members of the hospital care team in the department of obstetrics

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Exclusion Criteria

lack of ability to provide written informed consent

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Addresses

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    • Universitätsfrauenklinik Erlangen
    • Universitätsstr. 21-23
    • 91054  Erlangen
    • Germany
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    •   09131-85-33553
    •   [---]*
    •   [---]*
    •   [---]*
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    • Department of Obstetrics and Gynecology, Erlangen University Hospital
    • Mr.  PD Dr.  Alexander  Hein 
    • Universitätsstr. 21-23
    • 91054  Erlangen
    • Germany
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    • Frauenklinik, Universitätsklinikum Erlangen
    • Mr.  PD Dr.  Alexander  Hein 
    • Universitätsstr. 21-23
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsfrauenklinik Erlangen
    • Universitätsstr. 21-23
    • 91054  Erlangen
    • Germany
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    •   09131-85-33553
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.