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

H

Haukeland University Hospital

Status

Unknown

Conditions

Hyperemesis Gravidarum
Pregnancy

Treatments

Other: PUQE-form inclusion
Other: Intervention at discharge
Other: Nutritional form inclusion
Other: Blood sampling inclusion

Study type

Observational

Funder types

Other

Identifiers

NCT02619188
2015/894

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Jone Trovik, MD, PhD

Data sourced from clinicaltrials.gov

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