Trial document




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  DRKS00016768

Trial Description

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Title

Register study for the survey of births in patients with deep endometriosis

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Trial Acronym

[---]*

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URL of the Trial

http://endo-geburtenregister.kepleruniklinikum.at

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Brief Summary in Lay Language

The last few years have given us many insights into the impact of endometriosis on pregnancy complications (placenta previa, early abortions, prematurity, intraperitoneal bleeding, etc.). In contrast, very few studies have focused on the impact of endometriosis on delivery. In particular, the delivery outcome of patients with deep endometriosis (DE), both operated and unoperated, has not been sufficiently studied.
For this reason, a birth registry for deep infiltrating endometriosis has been created. The aim of this register is to assess the outcome of childbirth in women with deep infiltrating endometriosis in German-speaking countries. In the foreground of the birth register is the gathering of information on birth injuries, delivery mode and the influence on the born child. The results of this survey should help to better inform affected women about the birth and individual risks.

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Brief Summary in Scientific Language

Very few studies have dealt with the impact of endometriosis on delivery. In particular, the delivery outcome of deep endometriosis (DE), both operated and unoperated, has not been sufficiently studied. That is why a birth registry for deep endometriosis has been created. The general aim is to document peripartum parameters of women with deep endometriosis. The focus is on gaining information on the birth injuries, the delivery mode and the fetal outcome.

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Organizational Data

  •   DRKS00016768
  •   2019/02/21
  •   [---]*
  •   yes
  •   Approved
  •   1202/2018, Ethikkommission des Landes Oberösterreich
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Secondary IDs

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

  •   N80 -  Endometriosis
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Interventions/Observational Groups

  •   If a patient with deep endometriosis (operated or non-operated) gives birth in the participating clinics, the peripartum detalis are entered in an electronic database. The data input mask can be accessed via a center-specific access link. The study participants are thereby pseudonymized. When all the data has been entered correctly, the patient-specific record will be closed. Thus, the study participation of the patient is completed.
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Characteristics

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

The primary outcome is the documentation of peripartal parameters of women with deep endometriosis over a longer (not yet limited) time period. The focus is on gaining information on the birth injuries, the delivery mode and the fetal outcome.

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Secondary Outcome

/

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Countries of Recruitment

  •   Austria
  •   Germany
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/04/01
  •   500
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Deep endometriosis (operated and not-operated)
- Delivery
- Written consent to study participation (Informed Consent)

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Exclusion Criteria

- Multiple pregnancy
- Abnormal fetal position

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Addresses

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    • Kepler Universitätsklinikum
    • 4020  Linz
    • Austria
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie
    • Mr.  Dr.  Simon-Hermann  Enzelsberger 
    • Krankenhausstraße 26-30
    • 4020  Linz
    • Austria
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    • Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie
    • Mr.  Dr.  Simon-Hermann  Enzelsberger 
    • Krankenhausstraße 26-30
    • 4020  Linz
    • Austria
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Sources of Monetary or Material Support

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    • Kepler Universitätsklinikum
    • 4020  Linz
    • Austria
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Arbeitsgemeinschaft für Geburtshilfe und Pränatalmedizin (AGG) in der DGGG
    • Hausvogteiplatz 12
    • 10117  Berlin
    • 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.