Nutritional Markers in Normal and Hyperemesis Pregnancies

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hyperemesis Gravidarum, Pregnancy

Intervention / Treatment
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* Other: PUQE-form inclusion
* Other: Nutritional form inclusion
* Other: Blood sampling inclusion
* Other: Intervention at discharge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperemesis gravidarum<br>Hyperemesis gravidarum patients admitted to hospital PUQE-form inclusion (PUQE-score), Nutritional form inclusion, Blood sampling inclusion (Prealbumin analysis), Intervention at discharge : PUQE-form, Nutritional form and Blood sampling | Other: PUQE-form inclusion<br>* PUQE-form encompassing last 24 hours completion<br>* Other names: Pregnancy Unique Questionnare of Emesis;Other: Nutritional form inclusion<br>* Food-list form encompassing last 24 hours completion<br>Other: Blood sampling inclusion<br>* Measurement of biochemical nutrition marker(s); Prealbumin<br>Other: Intervention at discharge<br>* PUQE-form, nutritional form and Blood sampling<br>|
| Control: Healthy pregnant women<br>Outpatients NOT subjected to severe nausea and emesis (PUQE-score <13). PUQE-form inclusion (PUQE-score), Nutritional form inclusion, Blood sampling inclusion (Prealbumin analysis). | Other: PUQE-form inclusion<br>* PUQE-form encompassing last 24 hours completion<br>* Other names: Pregnancy Unique Questionnare of Emesis;Other: Nutritional form inclusion<br>* Food-list form encompassing last 24 hours completion<br>Other: Blood sampling inclusion<br>* Measurement of biochemical nutrition marker(s); Prealbumin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prealbumin in normal pregnancy | Serum Prealbumin measured during first trimester of pregnancy | Within 24h at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prealbumin related to nutritional parameters | Prealbumin level correlated to PUQE-score and weight change in normal and hyperemesis pregnancies | Within 24h at inclusion | 
| 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 | 
| Prealbumin in Hyperemesis gravidarum | Serum Prealbumin measured when admission to hospital | Within 2h from admission to hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Hyperemesis gravidarum, Prealbumin, Questionnaire