Pregnancy Clinical Trial
— PUQE-MOfficial title:
Pregnancy Unique Questionnaire of Emesis (PUQE) Methode Evaluation; Relation Between Rate of Nausea/Vomiting in Pregnancy (PUQE-score), Self-reported Nutritional Intake and Biochemical Nutritional Markers
This study evaluate the rate of nausea and nutritional status in patients with hyperemesis gravidarum (severe nausea and vomiting in pregnancy) and healthy pregnant women using a questionnaire (PUQE-score), self-reported food/drink intake form and blood test. The Investigators aim for developing normal range of prealbumin measurements (reference values) during first trimester of pregnancy.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 2018 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Pregnant women < 16 weeks of gestation - Admitted to hospital for hyperemesis gravidarum (HG group) with nausea and vomiting in pregnancy with at least two of following criteria; weight loss, dehydration, fluid-/electrolyte disturbances, ketonuria Exclusion Criteria: - Non-viable pregnancy diagnosed at time of inclusion - Unable to understand Norwegian - PUQE-score >= 13 (control group) - Nausea an vomiting in pregnancy caused by other conditions than Hyperemesis gravidarum |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Norway | Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital | Bergen | Hordaland |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | University of Bergen |
Norway,
Birkeland E, Stokke G, Tangvik RJ, Torkildsen EA, Boateng J, Wollen AL, Albrechtsen S, Flaatten H, Trovik J. Norwegian PUQE (Pregnancy-Unique Quantification of Emesis and nausea) identifies patients with hyperemesis gravidarum and poor nutritional intake: a prospective cohort validation study. PLoS One. 2015 Apr 1;10(4):e0119962. doi: 10.1371/journal.pone.0119962. eCollection 2015. — View Citation
Stokke G, Gjelsvik BL, Flaatten KT, Birkeland E, Flaatten H, Trovik J. Hyperemesis gravidarum, nutritional treatment by nasogastric tube feeding: a 10-year retrospective cohort study. Acta Obstet Gynecol Scand. 2015 Apr;94(4):359-67. doi: 10.1111/aogs.12578. Epub 2015 Feb 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prealbumin in normal pregnancy | Serum Prealbumin measured during first trimester of pregnancy | Within 24h at inclusion | No |
Secondary | Prealbumin related to nutritional parameters | Prealbumin level correlated to PUQE-score and weight change in normal and hyperemesis pregnancies | Within 24h at inclusion | No |
Secondary | Change in Prealbumin | Change in Serum Prealbumin during hospital treatment of hyperemesis gravidarum | Patients will be followed until discharge from hospital, a mean of 5 days, and blood sampling repeated at discharge | No |
Secondary | Prealbumin in Hyperemesis gravidarum | Serum Prealbumin measured when admission to hospital | Within 2h from admission to hospital | No |
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