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

NCT ID: NCT01836835

Last Updated: 2015-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-01-31

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.

Conditions

Hyperemesis Gravidarum

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Pregnancy Unique Questionnaire of Emesis (PUQE)

Intervention Type: OTHER

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.

24 hours self-reported nutritional intake form

Intervention Type: OTHER

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.

Healthy pregnant women

Women with presumed normal pregnancy Pregnancy Unique Questionnaire of Emesis (PUQE) and 24 hours self-reported nutritional intake form administered

Pregnancy Unique Questionnaire of Emesis (PUQE)

Intervention Type: OTHER

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.

24 hours self-reported nutritional intake form

Intervention Type: OTHER

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.

Interventions

Pregnancy Unique Questionnaire of Emesis (PUQE)

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.

Intervention Type: OTHER

24 hours self-reported nutritional intake form

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jone Trovik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital

Bergen, Hordaland, Norway

Dpt Obstetrics Gynaecology, Stavanger University Hospital

Stavanger, Rogaland, Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 18166311 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16147725 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7755076 (View on PubMed)

Other Identifiers

2013/465

Identifier Type: -

Identifier Source: org_study_id