Nutritional Markers in Normal and Hyperemesis Pregnancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hyperemesis Gravidarum Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

PUQE-form inclusion

Intervention Type OTHER

PUQE-form encompassing last 24 hours completion

Nutritional form inclusion

Intervention Type OTHER

Food-list form encompassing last 24 hours completion

Blood sampling inclusion

Intervention Type OTHER

Measurement of biochemical nutrition marker(s); Prealbumin

Intervention at discharge

Intervention Type OTHER

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).

PUQE-form inclusion

Intervention Type OTHER

PUQE-form encompassing last 24 hours completion

Nutritional form inclusion

Intervention Type OTHER

Food-list form encompassing last 24 hours completion

Blood sampling inclusion

Intervention Type OTHER

Measurement of biochemical nutrition marker(s); Prealbumin

Interventions

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PUQE-form inclusion

PUQE-form encompassing last 24 hours completion

Intervention Type OTHER

Nutritional form inclusion

Food-list form encompassing last 24 hours completion

Intervention Type OTHER

Blood sampling inclusion

Measurement of biochemical nutrition marker(s); Prealbumin

Intervention Type OTHER

Intervention at discharge

PUQE-form, nutritional form and Blood sampling

Intervention Type OTHER

Other Intervention Names

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Pregnancy Unique Questionnare of Emesis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes