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Nutritional Markers in Normal and Hyperemesis Pregnancies

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02619188
Acronym
PUQE-M
Enrollment
60
Registered
2015-12-02
Start date
2015-09-30
Completion date
2018-07-31
Last updated
2016-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperemesis Gravidarum, Pregnancy

Keywords

Nutrition, Hyperemesis gravidarum, Prealbumin, Questionnaire

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.

Interventions

OTHERPUQE-form inclusion

PUQE-form encompassing last 24 hours completion

OTHERNutritional form inclusion

Food-list form encompassing last 24 hours completion

OTHERBlood sampling inclusion

Measurement of biochemical nutrition marker(s); Prealbumin

OTHERIntervention at discharge

PUQE-form, nutritional form and Blood sampling

Sponsors

University of Bergen
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Prealbumin in normal pregnancyWithin 24h at inclusionSerum Prealbumin measured during first trimester of pregnancy

Secondary

MeasureTime frameDescription
Prealbumin related to nutritional parametersWithin 24h at inclusionPrealbumin level correlated to PUQE-score and weight change in normal and hyperemesis pregnancies
Change in PrealbuminPatients will be followed until discharge from hospital, a mean of 5 days, and blood sampling repeated at dischargeChange in Serum Prealbumin during hospital treatment of hyperemesis gravidarum
Prealbumin in Hyperemesis gravidarumWithin 2h from admission to hospitalSerum Prealbumin measured when admission to hospital

Countries

Norway

Contacts

Primary ContactJone Trovik, MD, PhD
jone.trovik@helse-bergen.no0047 55974200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026