Trial document





This trial has been registered retrospectively.
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  DRKS00007592

Trial Description

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Title

Study of female personality structures and influencing factors to the wish of a caesarean delivery without urgency (on maternal request)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The goal of the study is to analyse personality structures and influencing factors of women, who plan to deliver by caesarean section without urgency.
We analyse sections on maternal request retrospective and women who plan to deliver by caesarean section without urgency prospective.
To compare the results we use groups of women who already delivered by vaginal birth for the retrospective and women who plan to deliver by vaginal birth for the prospective part.

We use standardised questionnaires for both groups and an hairanalysis pre-birth to determine the stress level as well as a pressure test pre-birth to find out the threshold of pain for the prospective group.
Women who plan to deliver or delivered by vaginal birth serve as comparison group. They recieve the same documents.

We try to objectify the reasons of caesarean section without urgency for resolving them in future by interventions.

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Brief Summary in Scientific Language

We would like to analyse women who plan to deliver by caesarean section without urgency with standardised questionnaires as SCL-90 (mental stress), STAI and W-DEQ (fear of birth), HEXACO (personality), FSOZU (social support), EPDS (depression) and PNS, PFI, NFC modified by Hände 2002 (tolerance to ambiguity).
In addition to the questionnaires we determine the stress level with an hair analysis (LC-MS) and execute a quantative sensory testing for the threshold of pain.

Supplementary, we perform a retrospective analysis of caesarean sections by maternal request of the last years. For this purpose we contact and send them the questionnaires above quotation. Women who delivered by vaginal birth serve as comparison group.

When an expectant mother presents herself in our pregnancy ambulance she uses to be at least in her 34th week of gestation. A detailed talk about her mode of delivery takes place and - in case of delivery by caesarean section - the patient will be informed about the surgical procedure and a date will be fixed. Additional, the expectant mother will be informed about the study and all questions will be discussed.
As soon as the patient agrees, she will be distributed to the study group or the comparison group. Both groups get the same questionnaires, a quantitative sensory testing and a sample taking of hair (back of the head) will happen.

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Organizational Data

  •   DRKS00007592
  •   2015/02/09
  •   [---]*
  •   yes
  •   Approved
  •   2013-588N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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

  •   O82 -  Single delivery by caesarean section
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Interventions/Observational Groups

  •   Pregnant women who want to deliver by caesarean section without urgency receive standardized questionnaires, the stress level will be determined by a hair analysis (LC-MS) and a quantative sensory testing for the threshold of pain will be executed.
  •   Pregnant women who want to deliver by vaginal birth (comparison group) receive standardized questionnaires, the stress level will be determined by a hair analysis (LC-MS) and a quantative sensory testing for the threshold of pain will be executed.
  •   Women who delivered by caesarean section on maternal request receive questionnaires.
  •   Women who delivered by vaginal birth receive questionnaires.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Analysis of personality with questionnaires.
Distribution of a questionnaire designed by ourselves and of nine published questionnaires
to evaluate mental stress (SCL-90), fear of birth (W-DEQ), personality (HEXACO), social support (FSOZU), Depression (EPDS) and tolerante of ambiguity (PNS, PFI, NFC modified by Hände 2002)

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Secondary Outcome

Objectification of last month' stress level with LC-MS of hair from the back of the head as well as evaluation of algesia with quantitative sensory testing at the ball of the thumb.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/02/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- adult women who wish to deliver by caesarean section prospective
- adult women who wish to deliver by vaginal birth
- adult women who delivered by caesarean section on maternal request
- adult women who delivered by vaginal birth

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Exclusion Criteria

Caesarean section by urgency

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Frauenklinik der Universitätsmedizin Mannheim
    • Mr.  Prof. Dr. med.  Marc  Sütterlin 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Frauenklinik der Universitätsmedizin Mannheim
    • Mr.  Prof. Dr. med.  Marc  Sütterlin 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Frauenklinik der Universitätsmedizin Mannheim
    • Mr.  Priv.-Doz. Dr. med.  Benjamin  Tuschy 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Frauenklinik der Universitätsmedizin Mannheim
    • Mr.  Prof. Dr. med.  Marc  Sütterlin 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • 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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* This entry means the parameter is not applicable or has not been set.