The Effect of Healthy Eating Index on Maternal Thyroid Volume in Hyperemesis Gravidarum

January 8, 2021 updated by: Erhan Okuyan,M.D, Batman Training and Research Hospital
The relationship between healthy eating index and maternal thyroid volume in patients with hyperemesis gravidarum is planned.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Batman, Turkey, 72000
        • Batman Maternity and Child Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women between the ages of 15-49 who apply to our hospital

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Low eating index scores(50-70)
Diagnostic test: Maternal thyroid volume
Maternal thyroid volume measurement
2
High eating index scores(Above 70)
Diagnostic test: Maternal thyroid volume
Maternal thyroid volume measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
11-14 gestational week of pregnancy,Healty eating index scoresLow than 60 vs Higher than 60)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ketonuria, Notrophil / platelet ratio, TSH / ft3 ratio
Time Frame: 11-14 gestational week of pregnancy
Comparision of low and High eating index groups(Under 60 (low),Above 60(High))
11-14 gestational week of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Batman Training and Research Hospital

Collaborators

Baskent University

Investigators

  • Principal Investigator: Erhan Okuyan, Batman Maternity and Child Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

January 7, 2021

Study Completion (ACTUAL)

January 8, 2021

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (ACTUAL)

August 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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