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| Name | Class |
|---|---|
| University of Bergen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperemesis gravidarum | 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 |
| |
| Control: Healthy pregnant women | Outpatients NOT subjected to severe nausea and emesis (PUQE-score <13). PUQE-form inclusion (PUQE-score), Nutritional form inclusion, Blood sampling inclusion (Prealbumin analysis). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PUQE-form inclusion | Other | PUQE-form encompassing last 24 hours completion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prealbumin in normal pregnancy | Serum Prealbumin measured during first trimester of pregnancy | Within 24h at inclusion |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jone Trovik, MD, PhD | Contact | 0047 55974200 | 4256 | jone.trovik@helse-bergen.no |
| Name | Affiliation | Role |
|---|---|---|
| Jone Trovik, MD, PhD | Senior consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital | Recruiting | Bergen | Hordaland | 5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25830549 | Background | 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. | |
| 25581215 |
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| ID | Term |
|---|---|
| D006939 | Hyperemesis Gravidarum |
| ID | Term |
|---|---|
| D048968 | Morning Sickness |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Nutritional form inclusion | Other | Food-list form encompassing last 24 hours completion |
|
| Blood sampling inclusion | Other | Measurement of biochemical nutrition marker(s); Prealbumin |
|
| Intervention at discharge | Other | PUQE-form, nutritional form and Blood sampling |
|
| 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 |
| Background |
| 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. |
| D014839 | Vomiting |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |