Hyperemesis GravidarumNCT06245811
Inflammation Markers in Hyperemesis Gravidarum
An observational study of Hyperemesis Gravidarum, run by Izzet Celegen at 1 site in Turkey (Türkiye).
Trial summary
In this study, the relationship between the severity of hyperemesis gravidarum (HEG) disease and subclinical inflammatory factors such as Platelet Crit (PCT), Hemoglobin/red cell distribution width ratio (HRR), Neutrophil/lymphocyte ratio (NLR), was investigated. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hyperemesis Gravidarum
- How many people
- 215 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2022to 20 Jun 2022
- 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 45 years
- Women only
- Adult
Study population: A total of 213 pregnant women, including 102 pregnant women with hyperemesis gravidarum and 113 healthy pregnant women between 5-16 weeks of age, were included in the study.
Who may be able to join
- Healthy pregnant women over 18 years of age
- 5-16 weeks of gestation.
Who cannot join
- Smoking, urinary tract infections, previously diagnosed psychological disorders, gastrointestinal disorders, multiple pregnancies, eating disorders, thyroid disorders, inflammatory disease, pregnancy with assisted fertilization technique.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yil University, Faculty of Medicine
Van
About this study
Official title: Evaluation of the Relationship Between Hyperemesis Gravidarum (HEG) With Platelet Crit (PCT), Haemoglobin to Red Cell Distribution Width Ratio (HRR) and Neutrophil to Lymphocyte Ratio (NLR).
In this study, the relationship between the severity of hyperemesis gravidarum (HEG) disease and subclinical inflammatory factors such as Platelet Crit (PCT), Hemoglobin/red cell distribution width ratio (HRR), Neutrophil/lymphocyte ratio (NLR), was investigated.
Read the detailed description
A total of 215 pregnant women, 102 with hyperemesis gravidarum and 113 healthy pregnant women, were included in the study. HEG patients were divided into three groups according to the modified PUQE classification: mild (n=38), moderate (n=32) and severe (n=32).
In our study, we proposed using a new prognostic marker for HEG patients. We think that our study will be a source for future studies on HEG.
- Conditions
- Hyperemesis Gravidarum
- Keywords
- Hyperemesis gravidarum, Platelet criterion (PCT), Hemoglobin/red cell distribution width ratio (HRR), Neutrophil/lymphocyte ratio (NLR)
- Medical subject headings
- Hyperemesis Gravidarum
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pregnancy Unique Quantification of Emesis/Stomach scoring system
1: Weight loss of 5% or more since the beginning of pregnancy 2: Vomiting at least three times a day 3: A ketonuria value of +1 or higher on a urinalysis test
Measured: 2 months
Secondary outcomes (1)
Body mass index
(BMI) (kg/m2) was obtained by dividing body weight (kg) by height (m2) squared
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start20 Jan 2022
- Primary completion20 Mar 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izzet Celegen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Izzet Celegen, Yuzuncu Yil University
- Investigators
- Kazım Uçkan, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245811
- Sponsor's protocol ID
- UCKAN001
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Hyperemesis Gravidarum (HEG) With Platelet Crit (PCT), Haemoglobin to Red Cell Distribution Width Ratio (HRR) and Neutrophil to Lymphocyte Ratio (NLR).
- ClinicalTrials.gov ID
- NCT06245811
- Acronym / sponsor ID
- UCKAN001
- Conditions
- Hyperemesis Gravidarum
- Keywords
- Hyperemesis gravidarum, Platelet criterion (PCT), Hemoglobin/red cell distribution width ratio (HRR), Neutrophil/lymphocyte ratio (NLR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Izzet CelegenUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 7 Feb 2024 (actual)
- 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.
In this study, the relationship between the severity of hyperemesis gravidarum (HEG) disease and subclinical inflammatory factors such as Platelet Crit (PCT), Hemoglobin/red cell distribution width ratio (HRR), Neutrophil/lymphocyte ratio (NLR), was investigated.
Detailed description
A total of 215 pregnant women, 102 with hyperemesis gravidarum and 113 healthy pregnant women, were included in the study. HEG patients were divided into three groups according to the modified PUQE classification: mild (n=38), moderate (n=32) and severe (n=32).
In our study, we proposed using a new prognostic marker for HEG patients. We think that our study will be a source for future studies on HEG.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- A total of 213 pregnant women, including 102 pregnant women with hyperemesis gravidarum and 113 healthy pregnant women between 5-16 weeks of age, were included in the study.
Key inclusion criteria (2 listed)
- Healthy pregnant women over 18 years of age
- 5-16 weeks of gestation.
Key exclusion criteria (1 listed)
- Smoking, urinary tract infections, previously diagnosed psychological disorders, gastrointestinal disorders, multiple pregnancies, eating disorders, thyroid disorders, inflammatory disease, pregnancy with assisted fertilization technique.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Pregnancy Unique Quantification of Emesis/Stomach scoring system
Time frame: 2 months
1: Weight loss of 5% or more since the beginning of pregnancy 2: Vomiting at least three times a day 3: A ketonuria value of +1 or higher on a urinalysis test
1 secondary outcome
Body mass index
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
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Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Haloperidol For Outpatient Symptom Management in Patients Diagnosed With Cannabinoid Hyperemesis Syndrome in the Emergrency Department
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Hyperemesis Gravidarum Risk Reduction With Metformin
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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.
Kazım Uçkan principal investigator
Yuzuncu Yil University
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, run by Izzet Celegen at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 7 Feb 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pregnancy Unique Quantification of Emesis/Stomach scoring system (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2024.