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

NCT01836835 | Completed

• 1 other identifier: 2013/465
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 2

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.

Conditions

Hyperemesis Gravidarum

Keywords

Hyperemesis gravidarum; Pregnancy; Nausea; Nutritional status; Questionnaire; Case-control

Outcome Measures

Primary Outcomes (1)

• Pregnancy Unique Questionnaire of Emesis (PUQE) score reported by hyperemesis patients versus normal pregnant women

  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

  24 hours after inclusion

Secondary Outcomes (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 Outcomes (4)

• Change in Pregnancy Unique Questionnaire of Emesis (PUQE) score from hospital admittance to discharge

  From hospital admission to discharge, mean 7 days

• 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)

• Change of Pregnancy Unique Questionnaire of Emesis (PUQE) score and patient weight (kg)

  From inclusion to delivery (mean 7 months)

Study Arms (2)

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); Other: 24 hours self-reported nutritional intake form

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); Other: 24 hours self-reported nutritional intake form

Interventions

Pregnancy Unique Questionnaire of Emesis (PUQE) 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.

Healthy pregnant women; Hyperemesis gravidarum

24 hours self-reported nutritional intake form 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; Hyperemesis gravidarum

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Pregnant healthy women (controls)
• Patients admitted to hospital for hyperemesis gravidarum

You may not qualify if:

• Unable to understand and read/write Norwegian
• Conditions other than hyperemesis leading to nausea/vomiting

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (2)

Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

Location

Dpt Obstetrics Gynaecology, Stavanger University Hospital

Stavanger, Rogaland, 4000, Norway

Location

Related Publications (3)

• 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.

  PMID: 18166311 BACKGROUND

• 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.

  PMID: 16147725 BACKGROUND

• 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.

  PMID: 7755076 BACKGROUND

MeSH Terms

Conditions

Hyperemesis Gravidarum; Nausea

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jone Trovik, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 22, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

NO (2)