Nutritional Markers in Normal and Hyperemesis Pregnancies

NCT02619188 | Unknown

• 1 other identifier: 2015/894
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemesis Gravidarum; Pregnancy

Keywords

Nutrition; Hyperemesis gravidarum; Prealbumin; Questionnaire

Outcome Measures

Primary Outcomes (1)

• Prealbumin in normal pregnancy

  Serum Prealbumin measured during first trimester of pregnancy

  Within 24h at inclusion

Secondary Outcomes (3)

• Prealbumin related to nutritional parameters

  Within 24h at inclusion

• Change in Prealbumin

  Patients will be followed until discharge from hospital, a mean of 5 days, and blood sampling repeated at discharge

• Prealbumin in Hyperemesis gravidarum

  Within 2h from admission to hospital

Study Arms (2)

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; Other: Nutritional form inclusion; Other: Blood sampling inclusion; Other: Intervention at discharge

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; Other: Nutritional form inclusion; Other: Blood sampling inclusion

Interventions

PUQE-form inclusion OTHER

PUQE-form encompassing last 24 hours completion

Also known as: Pregnancy Unique Questionnare of Emesis

Control: Healthy pregnant women; Hyperemesis gravidarum

Nutritional form inclusion OTHER

Food-list form encompassing last 24 hours completion

Control: Healthy pregnant women; Hyperemesis gravidarum

Blood sampling inclusion OTHER

Measurement of biochemical nutrition marker(s); Prealbumin

Control: Healthy pregnant women; Hyperemesis gravidarum

Intervention at discharge OTHER

PUQE-form, nutritional form and Blood sampling

Hyperemesis gravidarum

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Unable to understand Norwegian
• PUQE-score \>= 13 (control group)
• Nausea an vomiting in pregnancy caused by other conditions than Hyperemesis gravidarum

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

RECRUITING

Related 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.

  PMID: 25830549 BACKGROUND

• 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.

  PMID: 25581215 BACKGROUND

MeSH Terms

Conditions

Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jone Trovik, MD, PhD

  Senior consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jone Trovik, MD, PhD

CONTACT

0047 55974200; jone.trovik@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: December 2, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2018
• Last Updated: October 5, 2016

Record last verified: 2016-10

Locations

NO (1)