Hyperemesis GravidarumPUQE-MNCT02619188
Nutritional Markers in Normal and Hyperemesis Pregnancies
An observational study of Hyperemesis Gravidarum and Pregnancy, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperemesis Gravidarum, Pregnancy
- What is being tested?
- PUQE-form inclusion, Nutritional form inclusion and Blood sampling inclusion
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2015to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * Women admitted to hospital due to Hyperemesis gravidarum * Healthy pregnant women (without hyperemesis gravidarum)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Dpt. of Obstetrics and Gynaecology, Haukeland University Hospital
Bergen, Hordaland, 5021
Jone Trovik, MD, PhD, 55974200 ext. 4256, jone.trovik@helse-bergen.no
Jone Trovik, MD, PhD
About this study
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
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.
Read the 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.
- Conditions
- Hyperemesis Gravidarum, Pregnancy
- Being tested
- PUQE-form inclusion, Nutritional form inclusion, Blood sampling inclusion, Intervention at discharge
- Keywords
- Nutrition, Hyperemesis gravidarum, Prealbumin, Questionnaire
- Medical subject headings
- Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUQE-form inclusionOther
Also called Pregnancy Unique Questionnare of Emesis
PUQE-form encompassing last 24 hours completion
Nutritional form inclusionOther
Food-list form encompassing last 24 hours completion
Blood sampling inclusionOther
Measurement of biochemical nutrition marker(s); Prealbumin
Intervention at dischargeOther
PUQE-form, nutritional form and Blood sampling
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: PUQE-form inclusion; Other: Nutritional form inclusion; Other: Blood sampling inclusion; Other: Intervention at discharge | |
| 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). Receives: Other: PUQE-form inclusion; Other: Nutritional form inclusion; Other: Blood sampling inclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prealbumin in normal pregnancy
Serum Prealbumin measured during first trimester of pregnancy
Measured: Within 24h at inclusion
Secondary outcomes (3)
Prealbumin related to nutritional parameters
Prealbumin level correlated to PUQE-score and weight change in normal and hyperemesis pregnancies
Measured: Within 24h at inclusion
Change in Prealbumin
Change in Serum Prealbumin during hospital treatment of hyperemesis gravidarum
Measured: Patients will be followed until discharge from hospital, a mean of 5 days, and blood sampling repeated at discharge
Prealbumin in Hyperemesis gravidarum
Serum Prealbumin measured when admission to hospital
Measured: Within 2h from admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Jone Trovik, MD, PhD, Principal investigator, Senior consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619188
- Sponsor's protocol ID
- 2015/894
- Acronym
- PUQE-M
- Status last verified
- Oct 2016
- First submitted
- 9 Sep 2015
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Birkeland E, Stokke G, Tangvik RJ, Torkildsen EA, Boateng J, Wollen AL, Albrechtsen S, Flaatten H, Trovik J. Norwegian PUQE (Pregnancy-Unique Quantification of Emesis and nausea) identifies patients with hyperemesis gravidarum and poor nutritional intake: a prospective cohort validation study. PLoS One. 2015 Apr 1;10(4):e0119962. doi: 10.1371/journal.pone.0119962. eCollection 2015.
PubMed 25830549Stokke G, Gjelsvik BL, Flaatten KT, Birkeland E, Flaatten H, Trovik J. Hyperemesis gravidarum, nutritional treatment by nasogastric tube feeding: a 10-year retrospective cohort study. Acta Obstet Gynecol Scand. 2015 Apr;94(4):359-67. doi: 10.1111/aogs.12578. Epub 2015 Feb 17.
PubMed 25581215
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02619188
- Acronym / sponsor ID
- PUQE-M / 2015/894
- Conditions
- Hyperemesis Gravidarum, Pregnancy
- Keywords
- Nutrition, Hyperemesis gravidarum, Prealbumin, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Sep 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperemesis gravidarum | – | Other: PUQE-form inclusion, Other: Nutritional form inclusion, Other: Blood sampling inclusion, Other: Intervention at dischargeHyperemesis 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 |
| Control: Healthy pregnant women | – | Other: PUQE-form inclusion, Other: Nutritional form inclusion, Other: Blood sampling inclusionOutpatients NOT subjected to severe nausea and emesis (PUQE-score <13). PUQE-form inclusion (PUQE-score), Nutritional form inclusion, Blood sampling inclusion (Prealbumin analysis). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Women admitted to hospital due to Hyperemesis gravidarum * Healthy pregnant women (without hyperemesis gravidarum)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUQE-form inclusionAlso: Pregnancy Unique Questionnare of EmesisPUQE-form encompassing last 24 hours completion | Other | Control: Healthy pregnant women, Hyperemesis gravidarum |
| Nutritional form inclusionFood-list form encompassing last 24 hours completion | Other | Control: Healthy pregnant women, Hyperemesis gravidarum |
| Blood sampling inclusionMeasurement of biochemical nutrition marker(s); Prealbumin | Other | Control: Healthy pregnant women, Hyperemesis gravidarum |
| Intervention at dischargePUQE-form, nutritional form and Blood sampling | Other | Hyperemesis gravidarum |
Primary outcome
Prealbumin in normal pregnancy
Time frame: Within 24h at inclusion
Serum Prealbumin measured during first trimester of pregnancy
3 secondary outcomes
Prealbumin related to nutritional parameters
Time frame: Within 24h at inclusion
Change in Prealbumin
Time frame: Patients will be followed until discharge from hospital, a mean of 5 days, and blood sampling repeated at discharge
Prealbumin in Hyperemesis gravidarum
Time frame: Within 2h from admission to hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Background: PubMed 25830549Birkeland E, Stokke G, Tangvik RJ, Torkildsen EA, Boateng J, Wollen AL, Albrechtsen S, Flaatten H, Trovik J. Norwegian PUQE (Pregnancy-Unique Quantification of Emesis and nausea) identifies patients with hyperemesis gravidarum and poor nutritional intake: a prospective cohort validation study. PLoS One. 2015 Apr 1;10(4):e0119962. doi: 10.1371/journal.pone.0119962. eCollection 2015.
- Background: PubMed 25581215Stokke G, Gjelsvik BL, Flaatten KT, Birkeland E, Flaatten H, Trovik J. Hyperemesis gravidarum, nutritional treatment by nasogastric tube feeding: a 10-year retrospective cohort study. Acta Obstet Gynecol Scand. 2015 Apr;94(4):359-67. doi: 10.1111/aogs.12578. Epub 2015 Feb 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jone Trovik, MD, PhD principal investigator
Senior consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperemesis Gravidarum and Pregnancy, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jone Trovik, MD, PhD (0047 55974200 ext. 4256, jone.trovik@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prealbumin in normal pregnancy (time frame: Within 24h at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619188, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.