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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02619188
Other study ID # 2015/894
Secondary ID
Status Recruiting
Phase N/A
First received September 9, 2015
Last updated October 4, 2016
Start date September 2015
Est. completion date July 2018

Study information

Verified date October 2016
Source Haukeland University Hospital
Contact Jone Trovik, MD, PhD
Phone 0047 55974200
Email jone.trovik@helse-bergen.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2018
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
PUQE-form inclusion
PUQE-form encompassing last 24 hours completion
Nutritional form inclusion
Food-list form encompassing last 24 hours completion
Blood sampling inclusion
Measurement of biochemical nutrition marker(s); Prealbumin
Intervention at discharge
PUQE-form, nutritional form and Blood sampling

Locations

Country Name City State
Norway Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital Bergen Hordaland

Sponsors (2)

Lead Sponsor Collaborator
Haukeland University Hospital University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prealbumin in normal pregnancy Serum Prealbumin measured during first trimester of pregnancy Within 24h at inclusion No
Secondary Prealbumin related to nutritional parameters Prealbumin level correlated to PUQE-score and weight change in normal and hyperemesis pregnancies Within 24h at inclusion No
Secondary 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 No
Secondary Prealbumin in Hyperemesis gravidarum Serum Prealbumin measured when admission to hospital Within 2h from admission to hospital No
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