Trial document




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  DRKS00015730

Trial Description

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Title

Use of illicit drugs during pregnancy and its risks and outcomes for mother and child - focus cannabis
Pilot project CaSCH-T1

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Trial Acronym

CaSCH-T1

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URL of the Trial

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Brief Summary in Lay Language

Scientific research project to gain knowledge on type and extent of substance use during pregnancy und its risks and outcomes with focus on cannabinoids in Germany
Two-part pilot project:
(1) Systematic literature review concerning prevalence and outcomes of substance use (specifically cannabis) during pregnancy for mother and child
(2) Non-interventional anonymous online-survey with pregnant women/mothers and medical qualified personnel on the topic of substance use in general and cannabis in particular during pregnancy and its outcomes for mother and child

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Brief Summary in Scientific Language

The generic goal of the multi-module research project conducted by the research group "cannabinoids" at the medical center of the Munich university is to gain substantial knowledge on type and extent of substance use during pregnancy in Germany with a special focus on cannabis use.
The pilot project CaSCH-T1 financed by German Federal Ministry of Health contains a systematic literature review and an anonymous, non-interventional online survey with pregnant women and mothers as well as medical qualified personnel (e.g. gynecologists, midwifes). Both parts of the project aim to answer the following research questions:
(1) How high ist the prevalence of illicit substance use, particularly cannabis, during pregnancy?
(2) Which risks and outcomes of illicit substance use, particularly cannabis, during pregnancy are known evidence-based?
(3) Which risks and outcomes of cannabis use during pregnancy do the women and medical qualified personnel know?
(4) How does the medical qualified personnel handle cannabis use during pregnancy and which treatment would they start?

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Organizational Data

  •   DRKS00015730
  •   2018/12/18
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  •   yes
  •   Approved
  •   18-780, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   F10-F19 -  Mental and behavioural disorders due to psychoactive substance use
  •   DSM-5: substance use disorder
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Interventions/Observational Groups

  •   Pregnant women or mothers / medical qualified personnel will complete a one-time online survey.
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Characteristics

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

Prevalence of illicit substance use, especially cannabis, during pregnancy in Germany

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Secondary Outcome

State of knowledge of the target populations about risks and outcome of cannabis use during pregnancy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/12/17
  •   250
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

It is planned to receive completed questionnaires from 200 pregnant women/mothers and 50 medical qualified personnel who treat pregnant women/mothers with substance use.

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Exclusion Criteria

Interested participants who do not fit in one of the below defined populations are not eligible for participation at the online survey:
- Pregnant woman or mother
- Physician, midwife or other medical qualified personnel who treats pregnant women/mothers with substance use

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Addresses

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    • Klinikum der Universität MünchenForschungsgruppe Cannabinoide (Ltg. PD Dr. Eva Hoch)
    • Nußbaumstr. 7
    • 80336  München
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie Klinikum der Universität München Campus Innenstadt
    • Ms.  PD Dr. rer. nat.  Eva  Hoch 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
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    • Forschungsgruppe Cannabinoide (Ltg. PD Dr. Eva Hoch) Klinik und Poliklinik für Psychiatrie und Psychotherapie Klinikum der Universität MünchenCampus Innenstadt
    • Ms.  Sabine M.  Apelt 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/03/13
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Trial Publications, Results and other Documents

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