NCT04528186

Brief Summary

The relationship between healthy eating index and maternal thyroid volume in patients with hyperemesis gravidarum is planned.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

August 24, 2020

Last Update Submit

January 8, 2021

Conditions

Healthy DietThyroid HypertrophyPregnancy Emesis

Keywords

Thyroid volume, Healty eating index, Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Ketonuria, Notrophil / platelet ratio, TSH / ft3 ratio

    11-14 gestational week of pregnancy

Study Arms (2)

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

Maternal thyroid volumeDIAGNOSTIC_TEST

Maternal thyroid volume measurement

12

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • years old pregnant women
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batman Maternity and Child Health Hospital

Batman, 72000, Turkey (Türkiye)

Location

Study Officials

  • Erhan Okuyan

    Batman Maternity and Child Health Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 27, 2020

Study Start

August 1, 2020

Primary Completion

January 7, 2021

Study Completion

January 8, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)