Nutritional Markers in Normal and Hyperemesis Pregnancies

Pregnancy Clinical Trial

— PUQE-M  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02619188
• Other study ID #: 2015/894
• 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

• Hyperemesis Gravidarum
• Pregnancy

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