PUQE-M: Nutritional Markers in Normal and Hyperemesis Pregnancies

• Sponsor: Haukeland University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02619188
• Collaborator: University of Bergen (Other)
• Enrollment: 60
• Location: 1
• Duration (Months): 34
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperemesis Gravidarum; Pregnancy	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 Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: Sep 1, 2015
• Anticipated Primary Completion Date: May 1, 2017
• Anticipated Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Prealbumin in normal pregnancy [Within 24h at inclusion]

   Serum Prealbumin measured during first trimester of pregnancy

Secondary Outcome Measures

1. Prealbumin related to nutritional parameters [Within 24h at inclusion]

   Prealbumin level correlated to PUQE-score and weight change in normal and hyperemesis pregnancies

2. 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

3. Prealbumin in Hyperemesis gravidarum [Within 2h from admission to hospital]

   Serum Prealbumin measured when admission to hospital

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital	Bergen	Hordaland	Norway	5021

Sponsors and Collaborators

• Haukeland University Hospital
• University of Bergen

Investigators

• Principal Investigator: Jone Trovik, MD, PhD, Senior consultant

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT02619188
• Other Study ID Numbers: 2015/894
• First Posted: Dec 2, 2015
• Last Update Posted: Oct 5, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Haukeland University Hospital: Nutrition; Hyperemesis gravidarum; Prealbumin; Questionnaire
• Additional relevant MeSH terms: Hyperemesis Gravidarum

Study Results

No Results Posted as of Oct 5, 2016