Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004625

Trial Description

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Title

German HIV Pregnancy Register

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Trial Acronym

[---]*

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URL of the Trial

http://www.daignet.de

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Brief Summary in Lay Language

Nationwide data collection on HIV positive pregnant women und their neonates to further improve the care of HIV-mother-to-child-transmission in Germany. Interdisciplinary documentation by HIV specialists, obstetricians and pediatricians.

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Brief Summary in Scientific Language

The register is an epidemiological non interventional multicenter trial. German data on HIV positive pregnant women and their newborns are collected including antiretroviral therapy, course of pregnancy, mode of delivery and final outcome of the exposed baby. The data will be analyzed to understand the situation in Germany and further improve the management of HIV-infected pregnant women. The data will be transferred to the international antiretroviral pregnancy registry (APR).

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Organizational Data

  •   DRKS00004625
  •   2013/04/03
  •   [---]*
  •   yes
  •   Approved
  •   371/11, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  •   U1111-1141-2151 
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Health Condition or Problem studied

  •   B24 -  Unspecified human immunodeficiency virus [HIV] disease
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Interventions/Observational Groups

  •   The register is an epidemiological non interventional multicenter trial. German data on HIV positive pregnant women and their newborns are collected including antiretroviral therapy, course of pregnancy, mode of delivery and final outcome of the exposed baby. The data will be analyzed to understand the situation in Germany and further improve the management of HIV-infected pregnant women. The data will be transferred to the international antiretroviral pregnancy registry (APR).
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Characteristics

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

Number of infected children

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Secondary Outcome

Malformation in the newborns

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2013/03/01
  •   2500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

HIV-positive
Pregnant

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Exclusion Criteria

none

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Addresses

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    • Klinikum der JW Goethe Universität Frankfurt am Main Innere Medizin/MED II Infektiologie/HIVCENTER
    • Ms.  Dr. med.  Annette  Haberl 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Geschäftsstelle der Deutschen AIDS-Gesellschaft e.V. (DAIG)
    • Ms.  Nicole  Bentrup 
    • Sigmund-Freud-Straße 25
    • 53105  Bonn
    • Germany
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    • Klinikum der JW Goethe Universität Frankfurt am Main Innere Medizin/MED II Infektiologie/HIVCENTER
    • Ms.  Dr. med.  Annette  Haberl 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Klinikum der JW Goethe Universität Frankfurt am Main Innere Medizin/ MED II Infektiologie/HIVCENTER
    • Ms.  Dr. med.  Annette  Haberl 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche AIDS Gesellschaft e.V.
    • Sigmund-Freud-Straße 25
    • 53105  Bonn
    • Germany
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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.