Trial document





This trial has been registered retrospectively.
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  DRKS00011861

Trial Description

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Title

Fetotoxicity of NSAIDS and RAAS-inhibitors in the 2nd and 3rd trimester of pregnancy (paediatric-nephrologic approach)

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Trial Acronym

NSAIDs and RAAS-inhibitors in the 2nd and 3rd trimester of pregnancy

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URL of the Trial

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Brief Summary in Lay Language

It is well-known that medication during pregnancy can harm the unborn child even if exposure takes place after the first trimester. The aim of this study is to examine and specify the risk after maternal intake of the following medications during the fetal period (second and third trimester): Non-steroidal anti-inflammatory/analgesic drugs (NSAIDs), metamizole, angiotensin-converting-enzyme inhibitors (ACE inhibitors) or angiotensin I receptor antagonists (sartans).
Two sub-projects will examine, if specific pregnancy complications (fetopathy approach) or renal disorder in children occur more often (pediatric-nephrological approach) after intake of the above mentioned medications during late pregnancy. With the fetopathy approach, pregnant women with the following abnormalities on ultrasound will be examined regarding their medication during pregnancy: premature constriction or closure of ductus arteriosus, oligo- or anhydramnion. With the nephropathy approach, children and adolescents who were seen in the clinic for pediatric nephrology are interviewed with a questionnaire regarding maternal medication intake during pregnancy. Both sub-projects are registered as separate studies, this is the pediatric-nephrological approach. For the second sub-project see DRKS00011568.

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Brief Summary in Scientific Language

It is well-known that non-steroidal anti-inflammatory/analgesic drugs (NSAIDs) and RAAS-inhibitors (inhibitors of the renin-anginotensin-aldosetrone-system) can cause fetotoxic effects after exposure during late pregnancy. The aim of this study is to examine and specify the risk after maternal intake of the following medications during the fetal period (second and third) trimester: Non-steroidal anti-inflammatory/analgesic drugs (NSAIDs), metamizole, angiotensin-converting-enzyme inhibitors (ACE inhibitors) or angiotensin I receptor antagonists (sartans).
Maternal intake of NSAIDs can lead through their prostaglandin-inhibiting effect to premature closure of the ductus arteriosus and through inhibition of cox-2 to fetal kidney dysfunction. Possible symptoms of RAAS inhibitor fetopathy are oligohydramnios or anhydramnios, pulmonary hypoplasia, hypocalvaria, joint contractures and neonatal anuria.
To date there are no sufficient data for risk quantification of NSAID/RAAS-inhibitor fetopathy. Further aims of this study are to investigate the sensitive exposure time in which fetotoxic effects might occur and to evaluate if renal diseases might occur in later infancy after prenatal exposure.
In two sub-projects fetotoxic effects of the above mentioned medication will be examined. It is to be investigated after which gestational week an exposure can lead to a constriction of the ductus arteriosus and the development of an oligohydramnios (fetopathy approach). In addition, it is to be examined whether intrauterine exposure to these drugs has long-term effects on the renal function of exposed children or more frequently leads to the development of hypertonus in children and adolescents (pediatric-nephrological approach).
Both sub-projects are registered as separate studies, this is the pediatric-nephrological approach. For the second sub-project see DRKS00011568.

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Organizational Data

  •   DRKS00011861
  •   2017/03/31
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  •   yes
  •   Approved
  •   EA2/116/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   DRKS00011568  (DRKS-ID Studienteil Fetopathie-Ansatz)
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Health Condition or Problem studied

  •   I10 -  Essential (primary) hypertension
  •   Q61.4 -  Renal dysplasia
  •   Q60 -  Renal agenesis and other reduction defects of kidney
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Interventions/Observational Groups

  •   Children and teenagers with renal dysplasia, renal hypoplasia or essential hypertension are evaluated regarding certain medication (NSAIDs, metamizole, RAAS-inhibitors) during pregnancy (cases). For this purpose, all patients who were seen in the Charité clinic for pediatric nephrology in the past two years will be contacted by questionnaire.
  •   Children and teenagers without study diagnoses (renal dysplasia, renal hypoplasia, essential hypertension) are evaluated regarding certain medication (NSAIDs, metamizole, RAAS-inhibitors) during pregnancy (controls). For this purpose, all patients who were seen in the Charité clinic for pediatric nephrology in the past two years will be contacted by questionnaire.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Are renal hypoplasia or renal dysplasia or hypertension in children and adolescents more frequent when the mother has taken an NSAID, metamizole or RAAS-inhibitor in the second half of pregnancy? For this purpose, all patients who were seen in the Charité clinic for pediatric nephrology in the past two years will be contacted by questionnaire.

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Secondary Outcome

Are there any signs of a minimum exposure time and/or a minimum dose? For this purpose, all patients who were seen in the Charité clinic for pediatric nephrology in the past two years will be contacted by questionnaire.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/01/01
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients who had an apointment in the pediatric clinic for nephrology in the years 2015 and 2016.

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Exclusion Criteria

none

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Addresses

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    • Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
    • Mr.  Prof. Dr. med.  Christof  Schaefer 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
    • Ms.  Dr. med.  Stephanie  Padberg 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
    • Ms.  Dr. med.  Stephanie  Padberg 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesinstitut für Arzneimittel und Medizinprodukte
    • Georg-Kiesinger-Allee 3
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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