Clinical Trial: Nutritional Markers in Normal and Hyperemesis Pregnancies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Mar

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 Summary:

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.


Sponsor: Haukeland University Hospital

Current Primary Outcome: Prealbumin in normal pregnancy [ Time Frame: Within 24h at inclusion ]

Serum Prealbumin measured during first trimester of pregnancy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Prealbumin related to nutritional parameters [ Time Frame: Within 24h at inclusion ]
    Prealbumin level correlated to PUQE-score and weight change in normal and hyperemesis pregnancies
  • Change in Prealbumin [ Time Frame: Patients will be followed until discharge from hospital, a mean of 5 days, and blood sampling repeated at discharge ]
    Change in Serum Prealbumin during hospital treatment of hyperemesis gravidarum
  • Prealbumin in Hyperemesis gravidarum [ Time Frame: Within 2h from admission to hospital ]
    Serum Prealbumin measured when admission to hospital


Original Secondary Outcome: Same as current

Information By: Haukeland University Hospital

Dates:
Date Received: September 9, 2015
Date Started: September 2015
Date Completion: July 2018
Last Updated: October 4, 2016
Last Verified: October 2016