CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 69 enrolled
Drug / intervention
Pregnancy Unique Questionnaire of Emesis (PUQE) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01836835
NCT01836835N/ACompleted

Case-cohort Validation Study of Pregnancy Unique Questionnaire of Emesis (PUQE) in Norwegian

Haukeland University Hospital·observational·Posted Apr 22, 2013·Updated Mar 30, 2015

In Brief

An observational study evaluating Pregnancy Unique Questionnaire of Emesis (PUQE) and 24 hours self-reported nutritional intake form for Hyperemesis Gravidarum. Completed, enrolled 69 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesNorway
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2013
Enrollment StartMay 1, 2013
Primary CompletionApr 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.2 years ago

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.

24 hours self-reported nutritional intake formother

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.