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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Prealbumin in normal pregnancy
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Prealbumin in normal pregnancy
Time Frame: Within 24h at inclusion
Serum Prealbumin measured during first trimester of pregnancy
Secondary Outcomes
- Change in Prealbumin(Patients will be followed until discharge from hospital, a mean of 5 days, and blood sampling repeated at discharge)
- Prealbumin related to nutritional parameters(Within 24h at inclusion)
- Prealbumin in Hyperemesis gravidarum(Within 2h from admission to hospital)