NCT04054843

Completed

Afamin in Gestational Diabetes Mellitus

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital Source

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Other study identifiers

Sponsor study identifier

Afamin in GDM

Study Type

observational

Actual enrollment (reported)

80

Locations

1 country

Sites

1

Timeline

Study Start

September 1, 2019

Actual (reported)

Primary Completion

March 1, 2020

Actual (reported)

Study Completion

March 15, 2020

Actual (reported)

Brief Summary

This study includes pregnancies in 11 to 14 th gestational weeks. Investigators will sample maternal plasma in the first trimester and analyze maternal plasma afamin values. All these women will then be screened by two step OGTT. Investigators will compare afamin levels in GDM and control groups.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 80 participants
Study completion date: March 15, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
August 9, 2019
Actual (reported)
First Posted
August 13, 2019
Actual (reported)
Study Start
September 1, 2019
Actual (reported)
Primary Completion
March 1, 2020
Actual (reported)
Study Completion
March 15, 2020
Actual (reported)

Last Updated: December 16, 2020
Status Verified: December 2020
Last Update Submitted: December 14, 2020

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

Maternal plasma afamin levels In first trimester GDM prediction
The predictive value of first trimester maternal plasma afamin levels for the diagnosis of gestational diabetes mellitus in comparison with two step OGTT
6 months

Study Arms (2)

Gestational diabetes mellitus

First trimester pregnancies with gestational diabetes mellitus

Diagnostic Test: Afamin

Control

First trimester healthy pregnancies

Diagnostic Test: Afamin

Interventions

AfaminDiagnostic test

Plasma maternal afamin levels

ControlGestational diabetes mellitus

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 35 Years

Sexfemale(Gender-based eligibility)

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Women within 11 and 14 weeks of gestational weeks

You may qualify if:

singleton pregnancy,

Sponsors & Collaborators

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Otherlead
Ankara University
Othercollaborator

Study Sites (1)

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Ankara, Turkey (Türkiye)

Enrollment

80 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 13, 2019

Study Start

September 1, 2019

Actual (reported)

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4 vs 7 Points Blood Glucose Monitoring in Gestational Diabetes on Dietary Modification

Not ApplicableCompleted

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The Effect of E-Health Management on Gestational Diabetes Control

Not ApplicableCompleted

NCT04550806

Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Prediction

Unknown

NCT05487352

Diagnostic Analysis of Oral Glucose Tolerance Test in Early Pregnancy for Gestational Diabetes Mellitus

Unknown

NCT04801485

D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China

Not ApplicableCompleted

NCT03380546

Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus.

Phase 3Terminated

having no fetal anomalies

having no pregestational diabetes

having no underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)

age \>18 or \< 35 years

fasting glucose level \< 105 mg/dL

You may not qualify if:

multiple pregnancy
fetal anomalies
pregestational diabetes
underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)
age \<18 or \> 35 years
fasting glucose level \> 105 mg/dL or random glucose level \> 200 mg/dL

Contact the study team to confirm eligibility.

Primary Completion

March 1, 2020

Actual (reported)

Study Completion

March 15, 2020

Actual (reported)

Last Updated

December 16, 2020

Record last verified: 2020-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04054843
Data provider: ClinicalTrials.gov
Source updated: 2020-12-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:55 UTC

Locations

TR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Gestational diabetes mellitus

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations