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

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