Nutritional Markers in Normal and Hyperemesis Pregnancies
Keywords
Abstract
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.
Dates
| Last Verified: | 09/30/2016 |
| First Submitted: | 09/08/2015 |
| Estimated Enrollment Submitted: | 11/29/2015 |
| First Posted: | 12/01/2015 |
| Last Update Submitted: | 10/03/2016 |
| Last Update Posted: | 10/04/2016 |
| Actual Study Start Date: | 08/31/2015 |
| Estimated Primary Completion Date: | 04/30/2017 |
| Estimated Study Completion Date: | 06/30/2018 |
Condition or disease
Intervention/treatment
Other: PUQE-form inclusion
Other: Nutritional form inclusion
Other: Blood sampling inclusion
Other: Hyperemesis gravidarum
Phase
Arm Groups
| 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: Hyperemesis gravidarum 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). |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Prealbumin in normal pregnancy [Within 24h at inclusion]
Secondary Outcome Measures
1. Prealbumin related to nutritional parameters [Within 24h at inclusion]
2. Change in Prealbumin [Patients will be followed until discharge from hospital, a mean of 5 days, and blood sampling repeated at discharge]
3. Prealbumin in Hyperemesis gravidarum [Within 2h from admission to hospital]
