Pregnancy Specific Nausea Questionnaire (PUQE) Translated and Tested in Norwegian
Keywords
Abstract
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.
Dates
| Last Verified: | 02/28/2015 |
| First Submitted: | 04/07/2013 |
| Estimated Enrollment Submitted: | 04/16/2013 |
| First Posted: | 04/21/2013 |
| Last Update Submitted: | 03/26/2015 |
| Last Update Posted: | 03/29/2015 |
| Actual Study Start Date: | 04/30/2013 |
| Estimated Primary Completion Date: | 03/31/2014 |
| Estimated Study Completion Date: | 12/31/2014 |
Condition or disease
Intervention/treatment
Other: Pregnancy Unique Questionnaire of Emesis (PUQE)
Other: 24 hours self-reported nutritional intake form
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Hyperemesis gravidarum Women diagnosed with hyperemesis gravidarum admitted to hospital Pregnancy Unique Questionnaire of Emesis (PUQE) and 24 hours self-reported nutritional intake form administered | |
| Healthy pregnant women Women with presumed normal pregnancy Pregnancy Unique Questionnaire of Emesis (PUQE) and 24 hours self-reported nutritional intake form administered |
Eligibility Criteria
| Ages Eligible for Study | 16 Years To 16 Years |
| Sexes Eligible for Study | Female |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Pregnancy Unique Questionnaire of Emesis (PUQE) score reported by hyperemesis patients versus normal pregnant women [24 hours after inclusion]
Secondary Outcome Measures
1. 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 [24 hours after inclusion]
Other Outcome Measures
1. Change in Pregnancy Unique Questionnaire of Emesis (PUQE) score from hospital admittance to discharge [From hospital admission to discharge, mean 7 days]
2. 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 [From pre-pregnancy to inclusion (mean 9 weeks pregnancy length)]
3. Change of Pregnancy Unique Questionnaire of Emesis (PUQE) score and patient weight (kg) [From inclusion to delivery (mean 7 months)]
4. Pregnancy Unique Questionnaire of Emesis (PUQE) score related to the baby's weight (kg)in hyperemesis patients versus normal pregnant women [From inclusion to delivery (mean 7 months)]
