Pregnancy Specific Nausea Questionnaire (PUQE) Translated and Tested in Norwegian
Condition: Hyperemesis Gravidarum
MeSH terms: Hyperemesis Gravidarum
Study type: Observational [Patient Registry]

Summary: 
      Nausea in early pregnancy (emesis gravidarum) is very common but most often self-limiting.
      Hyperemesis gravidarum; where nausea and vomiting is severe and protracted is potentially
      dangerous for the woman and her foetus and necessitates hospital treatment. An English
      questionnaire (PUQE; Pregnancy Unique Questionnaire of Emesis) exists that can differentiate
      between uncomplicated emesis and the severe hyperemesis condition. This questionnaire has
      been translated to Norwegian. The investigators want to test the ability of this
      questionnaire to differentiate the grade of nausea/vomiting between a group of presumed
      normal pregnant woman and patients treated for hyperemesis gravidarum in a Norwegian
      population. The investigators also want to relate the PUQE questionnaire scoring to the
      women/patients' self-reported nutritional intake during 24 hours.
    

Detailed description: 
      This is a prospective case-control study validating Pregnancy Unique Questionnaire of Emesis
      (PUQE) in a Norwegian population. The questionnaire has been translated from English to
      Norwegian by authorized translators. The Norwegian questionnaire's title is Svangerskaps
      Utløst Kvalme Kvantifisering (SUKK). The Norwegian version has been independently
      back-translated to English. The back-translated version has been approved by the original
      author Gideon Koren.

      The primary objective is to evaluate if the questionnaire score is significantly different
      between a group of presumed healthy pregnant woman and a group of patients hospitalized with
      hyperemesis gravidarum.

      The women will also fill in a self-reported 24-hours nutritional intake diary and this will
      be related to the Pregnancy Unique Questionnaire of Emesis (PUQE)score. For patients
      hospitalized with hyperemesis gravidarum the Pregnancy Unique Questionnaire of Emesis
      (PUQE)score both at admission and discharge will be compared.

      Background clinical information for both groups at enrollment will be recorded as well as
      pregnancy outcome for woman and child.

      The study has been approved by the Institutional Board as well as the Norwegian Regional
      Ethical Committee (REK Norway). Women will be included after giving informed written consent.
      Data will be stored electronically, anonymised, at a designated research server in accordance
      with the institutional research rules.

      The sample size have been determined on basis of a similar study evaluating different
      nutritional status in emesis and hyperemesis patients, using 20 patients in each group. We
      aim to include 30 patients in each group.

      Patients with diagnose of Hyperemesis gravidarum admitted form 1st of May 2013 will be
      consecutively asked to participate. Control patients will be recruited by invitation at
      primary care facilities or private out-patient gynaecologists.

      Statistical analyses will be performed using Statistical Package for the Social Sciences
      (SPSS). Categorical variables will be compared using Chi-square test and continuous variables
      by non-parametric tests. Paired test will be used when comparing Pregnancy Unique
      Questionnaire of Emesis (PUQE)scores sequentially from admittance to discharge.
    

Intervention name(s): Pregnancy Unique Questionnaire of Emesis (PUQE); 24 hours self-reported nutritional intake form
Intervention type(s): Other; Other
Intervention description(s): For hyperemesis gravidarum patients the Pregnancy Unique Questionnaire of Emesis (PUQE) (3 questions regarding the amount of nausea and vomiting during 24 hours) will be answered both at hospital admittance and discharge. For control patients the questionnaire will be answered at inclusion.; A nutritional intake form where relevant food and liquid items can be checked prospectively after consummation during 24 hours. This form will be filled in starting the morning following inclusion.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hyperemesis patients; recruited from university hospital clinic (normally 60 patients
        admitted during 12 months)

        Control paitients recruited from primary care/private practice out-patient gynaecologists
      
Keywords: Hyperemesis gravidarum; Pregnancy; Nausea; Nutritional status; Questionnaire; Case-control