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Trial record 38 of 359 for:    transthyretin

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

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ClinicalTrials.gov Identifier: NCT02619188
Recruitment Status : Unknown
Verified October 2016 by Haukeland University Hospital.
Recruitment status was:  Recruiting
First Posted : December 2, 2015
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease Intervention/treatment
Hyperemesis Gravidarum Pregnancy Other: PUQE-form inclusion Other: Nutritional form inclusion Other: Blood sampling inclusion Other: Intervention at discharge

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pregnancy Unique Questionnaire of Emesis (PUQE) Methode Evaluation; Relation Between Rate of Nausea/Vomiting in Pregnancy (PUQE-score), Self-reported Nutritional Intake and Biochemical Nutritional Markers
Study Start Date : September 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Group/Cohort 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: PUQE-form inclusion
PUQE-form encompassing last 24 hours completion
Other Name: Pregnancy Unique Questionnare of Emesis

Other: Nutritional form inclusion
Food-list form encompassing last 24 hours completion

Other: Blood sampling inclusion
Measurement of biochemical nutrition marker(s); Prealbumin

Other: Intervention at discharge
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).
Other: PUQE-form inclusion
PUQE-form encompassing last 24 hours completion
Other Name: Pregnancy Unique Questionnare of Emesis

Other: Nutritional form inclusion
Food-list form encompassing last 24 hours completion

Other: Blood sampling inclusion
Measurement of biochemical nutrition marker(s); Prealbumin




Primary Outcome Measures :
  1. Prealbumin in normal pregnancy [ Time Frame: Within 24h at inclusion ]
    Serum Prealbumin measured during first trimester of pregnancy


Secondary Outcome Measures :
  1. Prealbumin related to nutritional parameters [ Time Frame: Within 24h at inclusion ]
    Prealbumin level correlated to PUQE-score and weight change in normal and hyperemesis pregnancies

  2. Change in Prealbumin [ Time Frame: Patients will be followed until discharge from hospital, a mean of 5 days, and blood sampling repeated at discharge ]
    Change in Serum Prealbumin during hospital treatment of hyperemesis gravidarum

  3. Prealbumin in Hyperemesis gravidarum [ Time Frame: Within 2h from admission to hospital ]
    Serum Prealbumin measured when admission to hospital



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Women admitted to hospital due to Hyperemesis gravidarum
  • Healthy pregnant women (without hyperemesis gravidarum)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619188


Contacts
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Contact: Jone Trovik, MD, PhD 0047 55974200 ext 4256 jone.trovik@helse-bergen.no

Locations
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Norway
Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway, 5021
Contact: Jone Trovik, MD, PhD    55974200 ext 4256    jone.trovik@helse-bergen.no   
Principal Investigator: Jone Trovik, MD, PhD         
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
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Principal Investigator: Jone Trovik, MD, PhD Senior consultant

Publications:
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02619188     History of Changes
Other Study ID Numbers: 2015/894
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Haukeland University Hospital:
Nutrition
Hyperemesis gravidarum
Prealbumin
Questionnaire

Additional relevant MeSH terms:
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Hyperemesis Gravidarum
Morning Sickness
Pregnancy Complications
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms