Clinical trial NCT02619188: Nutritional Markers in Normal and Hyperemesis Pregnancies
Official 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperemesis Gravidarum
Pregnancy
Keywords: Nutrition
Hyperemesis gravidarum
Prealbumin
Questionnaire
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2015-12-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Women admitted to hospital due to Hyperemesis gravidarum
* Healthy pregnant women (without hyperemesis gravidarum)

Brief summary: 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.

Detailed description: Women affected with hyperemesis gravidarum are at severe nutritional risk. Reference values for biochemical parameters evaluating nutritional status during early pregnancy needs to be determined.

The investigators will compare clinical nutritional parameters (weight gain/weight loss) with rate of nausea (PUQE-questionnaire), self-reported nutritional intake form and biochemical measurements (prealbumin) in women admitted to hospital with hyperemesis gravidarum and healthy pregnant women.

For hyperemesis patients measurements will be repeated at discharge.

Eligibility criteria: 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

Primary outcomes:
measure: Prealbumin in normal pregnancy
timeFrame: Within 24h at inclusion
Secondary outcomes:
measure: Prealbumin related to nutritional parameters
timeFrame: Within 24h at inclusion
measure: Change in Prealbumin
timeFrame: Patients will be followed until discharge from hospital, a mean of 5 days, and blood sampling repeated at discharge
measure: Prealbumin in Hyperemesis gravidarum
timeFrame: Within 2h from admission to hospital
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital
state: Hordaland
Study officials:
affiliation: Senior consultant
name: Jone Trovik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.