Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003858

Trial Description

start of 1:1-Block title

Title

Which of the cord blood parameters suggest an experienced gestational diabetes ?

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The number of heavy newborns increases steadily. Often the gestational diabetes was not identified even though an increasing number of pregnant women are being screened. Which women are particularly affected by a gestational diabetes ? What are the risk factors ? Did they pass through a sugar test and what were the doctor´s recommandations? Moreover we believe that different parameters out of the cord blood can objectify a gestational diabetes. Therefore we are going to analyse laboratorially the cord blood of 80 female participants after childbirth. Aim of the study ist to improve medical care of women most exposed to risk and to gain a better insight into the causes and sequels of gestational diabetes.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The number of macrosomic newborn increases steadily. Often the gestational diabetes was not identified even though an increasing number of pregnant women are being screened. Which women are particularly affected by a gestational diabetes ? What are the risk factors ? Did they pass through an oral glucose tolerance test and was it realised and interpreted according to the AWMF guidelines ? Additionally we intend to investigate which of the laboratory parameters out of the cord blood are qualified to verify a diabetic metabolic status during pregnancy (considering unclear or missing diagnostic findings). For this 80 female participants in total (including 20 patients as control group) joined our study. We are going to collect anthropometric and demographic data of pregnant women and their newborns and determine different values within the cord blood (IGF-1, Leptin, Fructosamine, RBP4, EGF). Aim of the study ist to improve medical care of women most exposed to risk and to gain a better insight into the causes and sequels of gestational diabetes.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003858
  •   2012/07/09
  •   [---]*
  •   yes
  •   Approved
  •   377/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   O24.4 -  Diabetes mellitus arising in pregnancy
  •   P70.1 -  Syndrome of infant of a diabetic mother
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Diagnostic: Determination of different values within the cord blood of Newborns with experienced gestational diabetes.
    Other: Collecting antropometric and demographic data
  •   Diagnostic: Determination of different values within the cord blood of Newborns without dysfunction of glucose metabolism.
    Other: Collecting antropometric and demographic data
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Identification of laboratory parameters out of the cord blood, which are qualified to verify a diabetic metabolic status during pregnancy (considering unklear or missing diagnostic findings)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Evaluation of the implementation of the national gestational diabetes guidlines (AWMF) in Freiburg and surrounding area with the aid of a survey conducted over a period of 4 months.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/03/20
  •   80
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   37   Weeks of pregnancy
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Makrosomic newborns (> 90. Perzentile post partum)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Newborns < 37 weeks of pregnancy, dysmorphic signs or unknown duration of pregnancy

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätskinderklinik Freiburg
    • Mr.  Privatdozent Dr. med.   Roland  Hentschel 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätskinderklinik Freiburg
    • Mr.  Privatdozent Dr. med.  Roland  Hentschel 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätskinderklinik Freiburg
    • Ms.  Dr. med.  Alexandra  Krause 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätskinderklinik Freiburg
    • Mr.  PD Dr. med.  Roland  Hentschel 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/08/13
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.