Pregnancy Specific Nausea Questionnaire (PUQE) Translated and Tested in Norwegian

Study Overview
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Brief Summary
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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
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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.

Official Title
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Case-cohort Validation Study of Pregnancy Unique Questionnaire of Emesis (PUQE) in Norwegian

Conditions
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Hyperemesis Gravidarum

Intervention / Treatment
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* Other: Pregnancy Unique Questionnaire of Emesis (PUQE)
* Other: 24 hours self-reported nutritional intake form


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant healthy women (controls) Patients admitted to hospital for hyperemesis gravidarum Exclusion Criteria: Pregnancy duration at inclusion more than 16 weeks Unable to understand and read/write Norwegian Conditions other than hyperemesis leading to nausea/vomiting

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperemesis gravidarum<br>Women diagnosed with hyperemesis gravidarum admitted to hospital Pregnancy Unique Questionnaire of Emesis (PUQE) and 24 hours self-reported nutritional intake form administered | Other: Pregnancy Unique Questionnaire of Emesis (PUQE)<br>* 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.<br>Other: 24 hours self-reported nutritional intake form<br>* 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.<br>|
| Healthy pregnant women<br>Women with presumed normal pregnancy Pregnancy Unique Questionnaire of Emesis (PUQE) and 24 hours self-reported nutritional intake form administered | Other: Pregnancy Unique Questionnaire of Emesis (PUQE)<br>* 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.<br>Other: 24 hours self-reported nutritional intake form<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Unique Questionnaire of Emesis (PUQE) score reported by hyperemesis patients versus normal pregnant women | Pregnancy Unique Questionnaire of Emesis (PUQE) score range from 3 to 15. Scores reported for the first 24 hours after inclusion will be compared between hyperemesis patients and healthy pregnant control women | 24 hours after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Unique Questionnaire of Emesis (PUQE) score in relation to self reported 24 hours nutritional intake registration (estimated caloric intake)in hyperemesis patients versus normal pregnant women | The Pregnancy Unique Questionnaire of Emesis (PUQE) scores from hyperemesis and control women will be compared to self-reported 24 hours nutritional intake | 24 hours after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperemesis gravidarum, Pregnancy, Nausea, Nutritional status, Questionnaire, Case-control