Clinical trial NCT01836835: Pregnancy Specific Nausea Questionnaire (PUQE) Translated and Tested in Norwegian
Official title: Case-cohort Validation Study of Pregnancy Unique Questionnaire of Emesis (PUQE) in Norwegian
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperemesis Gravidarum
Keywords: Hyperemesis gravidarum
Pregnancy
Nausea
Nutritional status
Questionnaire
Case-control
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 69
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
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

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy Unique Questionnaire of Emesis (PUQE) score reported by hyperemesis patients versus normal pregnant women
timeFrame: 24 hours after inclusion
Secondary outcomes:
measure: 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
timeFrame: 24 hours after inclusion
Other outcomes:
measure: Change in Pregnancy Unique Questionnaire of Emesis (PUQE) score from hospital admittance to discharge
timeFrame: From hospital admission to discharge, mean 7 days
measure: Pregnancy Unique Questionnaire of Emesis (PUQE) score at inclusion related to change in patient weight (kg)from start of pregnancy to inclusion for hyperemesis patients versus normal pregnant women
timeFrame: From pre-pregnancy to inclusion (mean 9 weeks pregnancy length)
measure: Change of Pregnancy Unique Questionnaire of Emesis (PUQE) score and patient weight (kg)
timeFrame: From inclusion to delivery (mean 7 months)
measure: Pregnancy Unique Questionnaire of Emesis (PUQE) score related to the baby's weight (kg)in hyperemesis patients versus normal pregnant women
timeFrame: From inclusion to delivery (mean 7 months)
Locations:
city: Bergen
country: Norway
facility: Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital
state: Hordaland
city: Stavanger
country: Norway
facility: Dpt Obstetrics Gynaecology, Stavanger University Hospital
state: Rogaland
Study officials:
affiliation: Haukeland University Hospital
name: Jone Trovik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lacasse A, Rey E, Ferreira E, Morin C, Berard A. Validity of a modified Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) scoring index to assess severity of nausea and vomiting of pregnancy. Am J Obstet Gynecol. 2008 Jan;198(1):71.e1-7. doi: 10.1016/j.ajog.2007.05.051.
citation: Koren G, Piwko C, Ahn E, Boskovic R, Maltepe C, Einarson A, Navioz Y, Ungar WJ. Validation studies of the Pregnancy Unique-Quantification of Emesis (PUQE) scores. J Obstet Gynaecol. 2005 Apr;25(3):241-4. doi: 10.1080/01443610500060651.
citation: van Stuijvenberg ME, Schabort I, Labadarios D, Nel JT. The nutritional status and treatment of patients with hyperemesis gravidarum. Am J Obstet Gynecol. 1995 May;172(5):1585-91. doi: 10.1016/0002-9378(95)90501-4.