NCT04054843

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

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

First Submitted

Initial submission to the registry

August 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

August 9, 2019

Last Update Submit

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

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,
  • 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.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

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

Primary Completion

March 1, 2020

Study Completion

March 15, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations

TU(1)