Nutritional Markers in Normal and Hyperemesis Pregnancies (PUQE-M)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Hyperemesis Gravidarum
• Intervention / Treatment: Other: PUQE-form inclusion; Other: Nutritional form inclusion; Other: Blood sampling inclusion; Other: Intervention at discharge

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Jone Trovik, MD, PhD; Phone Number: 4256 0047 55974200; Email: jone.trovik@helse-bergen.no

Study Locations

• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Recruiting
      • Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital
      • Contact: Jone Trovik, MD, PhD; Phone Number: 4256 55974200; Email: jone.trovik@helse-bergen.no
      • Principal Investigator: Jone Trovik, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

• Women admitted to hospital due to Hyperemesis gravidarum
• Healthy pregnant women (without hyperemesis gravidarum)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: PUQE-form inclusion; PUQE-form encompassing last 24 hours completion; Other Names: Pregnancy Unique Questionnare of Emesis; Other: Nutritional form inclusion; Food-list form encompassing last 24 hours completion; Other: Blood sampling inclusion; Measurement of biochemical nutrition marker(s); Prealbumin; Other: 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).	Other: PUQE-form inclusion; PUQE-form encompassing last 24 hours completion; Other Names: Pregnancy Unique Questionnare of Emesis; Other: Nutritional form inclusion; Food-list form encompassing last 24 hours completion; Other: Blood sampling inclusion; Measurement of biochemical nutrition marker(s); Prealbumin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen
• Investigators: Principal Investigator: Jone Trovik, MD, PhD, Senior Consultant

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Nutrition; Questionnaire; Hyperemesis gravidarum; Prealbumin
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pregnancy Complications; Morning Sickness; Vomiting; Hyperemesis Gravidarum
• Other Study ID Numbers: 2015/894