Hyperemesis Gravidarum Clinical Trial
Official title:
Case-cohort Validation Study of Pregnancy Unique Questionnaire of Emesis (PUQE) in Norwegian
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.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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