The Effect of Healthy Eating Index on Maternal Thyroid Vo... | NCT04528186

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

NCT04528186

Sponsor

Batman Training and Research Hospital

Status

Completed

Last Update Posted

Jan 11, 2021Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Healthy Diet
Thyroid Hypertrophy
Pregnancy Emesis

Interventions

Maternal thyroid volume

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Jan 7, 2021Actual

Completion Date

Jan 8, 2021Actual

First Submitted Date

Aug 24, 2020

First Submission Date that Met QC Criteria

Aug 24, 2020

First Posted Date

Aug 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2021

Last Update Posted Date

Jan 11, 2021Actual

Name	Class
Baskent University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Low eating index scores(50-70)	Diagnostic Test: Maternal thyroid volume
2		High eating index scores(Above 70)	Diagnostic Test: Maternal thyroid volume

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Maternal thyroid volume	Diagnostic Test	Maternal thyroid volume measurement	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact on Maternal Thyroid volume measures	Maternal Thyroid volume measures	11-14 gestational week of pregnancy,Healty eating index scoresLow than 60 vs Higher than 60)

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

49 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erhan Okuyan	Batman Maternity and Child Health Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Batman Maternity and Child Health Hospital		Batman		72000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided