NCT Number: NCT01836835
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.
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Notify Me16 year–50 year
Female
Observational
Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital, Bergen, Hordaland, Norway
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 hours after inclusion
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
Time frame: 24 hours after inclusion
The Pregnancy Unique Questionnaire of Emesis (PUQE) scores from hyperemesis and control women will be compared to self-reported 24 hours nutritional intake
Time frame: From hospital admission to discharge, mean 7 days
Change in Pregnancy Unique Questionnaire of Emesis (PUQE) score for hyperemesis gravidarum patients from first assessment at hospital admission and again at hospital discharge
Time frame: From pre-pregnancy to inclusion (mean 9 weeks pregnancy length)
Change of weight (gain or loss) from pre-pregnant to time of inclusion related to Pregnancy Unique Questionnaire of Emesis (PUQE) scores for hyperemesis and control women
Time frame: From inclusion to delivery (mean 7 months)
Change of weight (gain or loss) from inclusion to time of delivery related to Pregnancy Unique Questionnaire of Emesis (PUQE) scores at inclusion for hyperemesis and control women
Time frame: From inclusion to delivery (mean 7 months)
Pregnancy Unique Questionnaire of Emesis (PUQE) scores at inclusion for hyperemesis versus control women is related to the baby's weight at delivery
Haukeland University Hospital
Other
Case-cohort Validation Study of Pregnancy Unique Questionnaire of Emesis (PUQE) in Norwegian
Acronym: PUQE-N
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