Healthy DietNCT04528186
The Effect of Healthy Eating Index on Maternal Thyroid Volume in Hyperemesis Gravidarum
An observational study of Healthy Diet and Thyroid Hypertrophy, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The relationship between healthy eating index and maternal thyroid volume in patients with hyperemesis gravidarum is planned. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Healthy Diet, Thyroid Hypertrophy, Pregnancy Emesis
- What is being tested?
- Maternal thyroid volume
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 8 Jan 2021
- 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 15 to 49 years
- Women only
- Child, Adult
Study population: Pregnant women between the ages of 15-49 who apply to our hospital
Who may be able to join
- 15-49 years old pregnant women
- 11-14 Gestational week of pregnancy
- Do not use medication,
- have no history of illness,
- who participated in face-to-face meetings with a dietician,
- who want to be included in the study,
- No smoking or alcohol consumption
- Patients with a BMI between 15-25
Who cannot join
- Pregnant women who are not between 15-49 years old,
- patients with chronic disease such as heart disease, diabetes,
- Patients who do not agree to meet with a dietician, patients who do not agree to be included in the study,
- smoking and alcohol use --Morbid-obese patients (BMI greater than 25)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Batman Maternity and Child Health Hospital
Batman, 72000
About this study
The relationship between healthy eating index and maternal thyroid volume in patients with hyperemesis gravidarum is planned.
Read the detailed description
In pregnant women(11-14 week) admitted to our hospital between the ages of 15-49; After the healthy eating index scores were made face to face by the dietician, it was planned to measure the maternal thyroid volume by the radiologist.Our hypothesis in our study is to determine whether healthy eating index has effects on thyroid volume and blood parameters.
- Conditions
- Healthy Diet, Thyroid Hypertrophy, Pregnancy Emesis
- Being tested
- Maternal thyroid volume
- Keywords
- Thyroid volume, , Healty eating index, , Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal thyroid volumeDiagnostic test
Maternal thyroid volume measurement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Low eating index scores(50-70) Receives: Diagnostic Test: Maternal thyroid volume | |
| 2 | High eating index scores(Above 70) Receives: Diagnostic Test: Maternal thyroid volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on Maternal Thyroid volume measures
Maternal Thyroid volume measures
Measured: 11-14 gestational week of pregnancy,Healty eating index scoresLow than 60 vs Higher than 60)
Secondary outcomes (1)
Ketonuria, Notrophil / platelet ratio, TSH / ft3 ratio
Comparision of low and High eating index groups(Under 60 (low),Above 60(High))
Measured: 11-14 gestational week of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Aug 2020
- Primary completion7 Jan 2021
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies 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
- Other
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Baskent University
- Responsible party
- Principal investigator, Erhan Okuyan,M.D, Batman Training and Research Hospital
- Investigators
- Erhan Okuyan, Principal investigator, Batman Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528186
- Sponsor's protocol ID
- 289
- Status last verified
- Jan 2021
- First submitted
- 24 Aug 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Healthy Eating Index on Maternal Thyroid Volume in Hyperemesis Gravidarum
- ClinicalTrials.gov ID
- NCT04528186
- Acronym / sponsor ID
- 289
- Conditions
- Healthy Diet, Thyroid Hypertrophy, Pregnancy Emesis
- Keywords
- Thyroid volume, , Healty eating index, , Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Batman Training and Research HospitalOther government
- Collaborators
- Baskent University
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 27 Aug 2020 (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.
The relationship between healthy eating index and maternal thyroid volume in patients with hyperemesis gravidarum is planned.
Detailed description
In pregnant women(11-14 week) admitted to our hospital between the ages of 15-49; After the healthy eating index scores were made face to face by the dietician, it was planned to measure the maternal thyroid volume by the radiologist.Our hypothesis in our study is to determine whether healthy eating index has effects on thyroid volume and blood parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Maternal thyroid volumeLow eating index scores(50-70) |
| 2 | – | Diagnostic Test: Maternal thyroid volumeHigh eating index scores(Above 70) |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Pregnant women between the ages of 15-49 who apply to our hospital
Key inclusion criteria (8 listed)
- 15-49 years old pregnant women
- 11-14 Gestational week of pregnancy
- Do not use medication,
- have no history of illness,
- who participated in face-to-face meetings with a dietician,
Key exclusion criteria (4 listed)
- Pregnant women who are not between 15-49 years old,
- patients with chronic disease such as heart disease, diabetes,
- Patients who do not agree to meet with a dietician, patients who do not agree to be included in the study,
- smoking and alcohol use --Morbid-obese patients (BMI greater than 25)
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 |
|---|---|---|
| Maternal thyroid volumeMaternal thyroid volume measurement | Diagnostic test | 1, 2 |
Primary outcome
Impact on Maternal Thyroid volume measures
Time frame: 11-14 gestational week of pregnancy,Healty eating index scoresLow than 60 vs Higher than 60)
Maternal Thyroid volume measures
1 secondary outcome
Ketonuria, Notrophil / platelet ratio, TSH / ft3 ratio
Time frame: 11-14 gestational week of pregnancy
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 11 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Erhan Okuyan principal investigator
Batman Maternity and Child Health Hospital
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 Healthy Diet and Thyroid Hypertrophy, run by Batman Training and Research Hospital 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 8 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: finished, as of the sponsor's last update on 11 Jan 2021. 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?
Impact on Maternal Thyroid volume measures (time frame: 11-14 gestational week of pregnancy,Healty eating index scoresLow than 60 vs Higher than 60)). 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 11 Jan 2021.