Nutritional Markers in Normal and Hyperemesis Pregnancies

• Conditions: Hyperemesis Gravidarum; Pregnancy
• Interventions: Other: PUQE-form inclusion; Other: Nutritional form inclusion; Other: Blood sampling inclusion; Other: Intervention at discharge

• Registration Number: NCT02619188
• Lead Sponsor: Haukeland University Hospital

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 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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05
• Primary Completion: 2017-05
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyperemesis gravidarum	PUQE-form inclusion	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	PUQE-form inclusion	Outpatients NOT subjected to severe nausea and emesis (PUQE-score \<13). PUQE-form inclusion (PUQE-score), Nutritional form inclusion, Blood sampling inclusion (Prealbumin analysis).
Control: Healthy pregnant women	Nutritional form inclusion	Outpatients NOT subjected to severe nausea and emesis (PUQE-score \<13). PUQE-form inclusion (PUQE-score), Nutritional form inclusion, Blood sampling inclusion (Prealbumin analysis).
Control: Healthy pregnant women	Blood sampling inclusion	Outpatients NOT subjected to severe nausea and emesis (PUQE-score \<13). PUQE-form inclusion (PUQE-score), Nutritional form inclusion, Blood sampling inclusion (Prealbumin analysis).
Hyperemesis gravidarum	Blood sampling inclusion	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
Hyperemesis gravidarum	Nutritional form inclusion	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
Hyperemesis gravidarum	Intervention at discharge	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

Primary Outcome Measures

Name	Time	Method
Prealbumin in normal pregnancy	Within 24h at inclusion	Serum Prealbumin measured during first trimester of pregnancy

Secondary Outcome Measures

Name	Time	Method
Change in Prealbumin	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 related to nutritional parameters	Within 24h at inclusion	Prealbumin level correlated to PUQE-score and weight change in normal and hyperemesis pregnancies
Prealbumin in Hyperemesis gravidarum	Within 2h from admission to hospital	Serum Prealbumin measured when admission to hospital

Trial Locations

Locations (1)

Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital; 🇳🇴 Bergen, Hordaland, Norway