Trial document




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  DRKS00014965

Trial Description

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Title

Experiencing and coping with repeated pregnancy losses among women and their partners

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Trial Acronym

EUWIF

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URL of the Trial

https://www.klinikum.uni-heidelberg.de/Gynaekologische-Psychologie.139867.0.html

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Brief Summary in Lay Language

Supporting couples with repeated pregnancy losses (RPLs) is a diagnostic and therapeutic challenge because few known causes for the occurrence of RPLs are known and no risk factor can be identified in about half of those affected. The suffering of couples is high, which often means that a detailed diagnosis and treatment strategy is required. As a rule, RPLs trigger mourning processes in affected women and their partners, the intensity and timing of which can vary greatly from person to person.
This study aims to identify risk factors such as anxiety, depression and low social support, as well as dysfunctional coping strategies in women with RPLs and their partners. In addition, the experience of the RPL and how patients and their partners deal with it should be assessed in detail. Another important aspect of the treatment is the satisfaction of the patients (and their partners) with the entire process of medical treatment and psychological counselling as well as support from the social environment and the partner.
The aim of this study is to identify psychological risk and protection factors in couples with repeated miscarriages and to determine the couples' need for support.

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Brief Summary in Scientific Language

The screening questionnaire ScreenIVF will be used (in abridged version) in this study to identify the risk factors anxiety, depression and low social support among women with recurrent pregnancy losses (RPLs) and their partners. Other risk factors are dysfunctional coping strategies: active-confronting coping behaviour (e.g. seeking medical help) is generally seen as a protective coping strategy, while active-avoiding coping (e.g. not allowing feelings about it) is seen as a risk factor. For this reason, this study aims to identify coping strategies among women with RPLs and their partners. An important aspect of treatment is also the satisfaction of patients with RPLs (and their partners) with the entire process of both medical treatment and psychological counselling as well as support from the social environment and the partner. For this reason, both closed questions (e.g. request for an information meeting or brochure on the RPLs, request for psychological counselling) and open questions (e.g. requests for a miscarriage consultation, wishes to the social environment) are listed in the questionnaire. As potential moderators, sociographic variables (such as unfulfilled desire to have children, level of education) are also collected, supplemented by medical data from the files (e.g. number and years of the RPLs, existing children, occupation).

The aim of the study is to assess the experience of RPLs and how patients and their partners deal with them, to identify psychosocial protective and risk factors in these couples and to assess the support needs of this group of patients (and their partners). In the long term, the expected results of this study should enable psychologically vulnerable patients (and their partners) to receive medical and psychological therapy and counselling tailored to their individual needs.

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Organizational Data

  •   DRKS00014965
  •   2018/08/10
  •   [---]*
  •   yes
  •   Approved
  •   S-422/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N96 -  Habitual aborter
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Interventions/Observational Groups

  •   Quantitative questionnaire cross-sectional study on women with first contact in consultation for repeated miscarriages and their partners.
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Characteristics

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

Women with recurrent pregnancy losses (RPLs) at first contact during consultation hours in the women's clinic and their partners receive a self-developed questionnaire on risk factors such as anxiety, depression and low social support as well as dysfunctional coping strategies. In addition, the experience of RPLs and how patients and their partners deal with it should be assessed, as should the satisfaction of patients (and their partners) with the entire process of both medical treatment and psychological counselling as well as support from the social environment and the partner.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/09/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

All women with recurrent pregnancy losses contacting the women's hospital for the first time are included in the study, who agreed to participate and who have sufficient knowledge of the German language. Only one of the two partners of a couple may also participate. The participants have to be at least 18 years old. Participants have to be competent persons.

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Exclusion Criteria

Exclusion criteria are persons not willing to participate, with insufficient knowledge of German or study drop-outs.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.