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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01836835
First received: April 8, 2013
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Hyperemesis Gravidarum
Other: Pregnancy Unique Questionnaire of Emesis (PUQE)
Other: 24 hours self-reported nutritional intake form

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Case-cohort Validation Study of Pregnancy Unique Questionnaire of Emesis (PUQE) in Norwegian

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Pregnancy Unique Questionnaire of Emesis (PUQE) score reported by hyperemesis patients versus normal pregnant women [ Time Frame: 24 hours after inclusion ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 [ Time Frame: 24 hours after inclusion ] [ Designated as safety issue: No ]
    The Pregnancy Unique Questionnaire of Emesis (PUQE) scores from hyperemesis and control women will be compared to self-reported 24 hours nutritional intake


Other Outcome Measures:
  • Change in Pregnancy Unique Questionnaire of Emesis (PUQE) score from hospital admittance to discharge [ Time Frame: From hospital admission to discharge, mean 7 days ] [ Designated as safety issue: No ]
    Change in Pregnancy Unique Questionnaire of Emesis (PUQE) score for hyperemesis gravidarum patients from first assessment at hospital admission and again at hospital discharge

  • 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 [ Time Frame: From pre-pregnancy to inclusion (mean 9 weeks pregnancy length) ] [ Designated as safety issue: No ]
    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

  • Change of Pregnancy Unique Questionnaire of Emesis (PUQE) score and patient weight (kg) [ Time Frame: From inclusion to delivery (mean 7 months) ] [ Designated as safety issue: No ]
    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

  • Pregnancy Unique Questionnaire of Emesis (PUQE) score related to the baby's weight (kg)in hyperemesis patients versus normal pregnant women [ Time Frame: From inclusion to delivery (mean 7 months) ] [ Designated as safety issue: No ]
    Pregnancy Unique Questionnaire of Emesis (PUQE) scores at inclusion for hyperemesis versus control women is related to the baby's weight at delivery


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other: 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.
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.
Healthy pregnant women
Women with presumed normal pregnancy Pregnancy Unique Questionnaire of Emesis (PUQE) and 24 hours self-reported nutritional intake form administered
Other: 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.
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.

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

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836835

Contacts
Contact: Jone Trovik, MD, PhD 55974200 ext 0047 jone.trovik@helse-bergen.no

Locations
Norway
Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway, 5021
Contact: Jone Trovik, MD, PhD    55974200 ext 4256    jone.trovik@helse-bergen.no   
Principal Investigator: Jone Trovik, MD, PhD         
Dpt Obstetrics Gynaecology, Stavanger University Hospital Recruiting
Stavanger, Rogaland, Norway, 4000
Contact: Erik A Torkildsen, MD, PhD    +47 05151    erik.andreas.torkildsen@sus.no   
Principal Investigator: Erik A Torkildsen, MD, PhD         
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Jone Trovik, MD, PhD Haukeland University Hospital
  More Information

Publications:
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01836835     History of Changes
Other Study ID Numbers: 2013/465
Study First Received: April 8, 2013
Last Updated: November 27, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
Hyperemesis gravidarum
Pregnancy
Nausea
Nutritional status
Questionnaire
Case-control

Additional relevant MeSH terms:
Hyperemesis Gravidarum
Morning Sickness
Pregnancy Complications
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014