NCT04238936

Brief Summary

Serum amyloid A and Interleukin-1 (IL-1) receptor antagonist (A-SAA and IL-1Ra) values;

  • Comparison of pregnant women with and without GDM diagnosis
  • Comparison of insulin therapy and diet-regulated GDM patients
  • Comparison of pregnant women with and without LGA (large gestational age)
  • Comparison of pregnant women with and without polyhydroamnios
  • Investigation of its effect on pregnancy prognosis
  • In the prediction of GDM diagnosis, it is aimed to study the sensitivity and specificity of both parameters and cut off values. (In GDM patients, liver and kidney function parameters will also be evaluated with A-SAA and IL-1Ra levels).

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 Jan 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

January 20, 2020

Last Update Submit

May 21, 2020

Conditions

Gestational Diabetes

Keywords

Gestational DiabetesSerum amyloid AInterleukin-1 (IL-1) receptor antagonist

Outcome Measures

Primary Outcomes (2)

  • Serum amyloid A

    Its level will be checked in the study group consisting of pregnant women with GDM and in the control group consisting of healthy pregnant women.

    1 week

  • Interleukin-1 (IL-1) receptor antagonist

    Its level will be checked in the study group consisting of pregnant women with GDM and in the control group consisting of healthy pregnant women.

    1 week

Study Arms (2)

study group ; Patients with gestational diabetes

Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

Diagnostic Test: Serum amyloid A valuesDiagnostic Test: Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)

control group ; healthy pregnant women

Women who are healthy pregnant women, the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

Diagnostic Test: Serum amyloid A values

Interventions

Serum amyloid A valuesDIAGNOSTIC_TEST

Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

control group ; healthy pregnant womenstudy group ; Patients with gestational diabetes
Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)DIAGNOSTIC_TEST

Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

study group ; Patients with gestational diabetes

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Serum amyloid A (SAA) and Interleukin-1 (IL-1) receptor antagonist level will be examined in the study group consisting of pregnant women with GDM diagnosis and in the control group consisting of healthy pregnant women.

You may qualify if:

  • Patients with 50 gr OGTT + 100 gr OGTT + at 24-28 weeks of gestation
  • Patients with 75 gr OGTT + at 24-28 weeks of gestation
  • years pregnant women

You may not qualify if:

  • any infection
  • Any known fetal chromosomal or structural anomaly
  • Preterm membrane rupture
  • Preterm delivery
  • Preeclampsia or eclampsia
  • Placenta previa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 23, 2020

Study Start

January 20, 2020

Primary Completion

May 20, 2020

Study Completion

May 20, 2020

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations

TU(1)