Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

Study Overview
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Brief Summary
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To compare Factor XII levels in gestational diabetic and healthy pregnancies.

Detailed Description
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Thirty singleton term pregnant women with a diagnosis of Type I, Type II or gestational diabetes and thirty singleton uncomplicated term healthy pregnant women will be included in our study. Our study will be performed at Istanbul Acibadem Maslak Hospital, Turkey. Blood will be drawn from each patient when they are hospitalized and before they deliver either vaginally or by cesarean section. Blood will be drawn into two citrate tubes, each will contain 4 ml blood. Blood will be transferred to the lab immediately and will be centrifuged. The supernatant will be stored at -80°C. When the anticipated number of samples are completed Factor XII levels will be calculated in each sample.

Official Title
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Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

Conditions
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Diabetic Pregnancy, Pregnancy Related, Complement System; Disorder

Intervention / Treatment
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* Diagnostic Test: Diabetic pregnancy
* Diagnostic Test: Non-diabetic pregnancy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term pregnancy Pregnant patients with a diagnosis of Type I diabetes Pregnant patients with a diagnosis of Type II diabetes Pregnant patients with a diagnosis of Gestational diabetes Non-diabetic pregnancies Uncomplicated pregnancies Exclusion Criteria: Preterm pregnancy Postterm pregnancy Pregnant patients with a diagnosis of systemic diseases other than diabetes Complicated pregnancies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic pregnancy<br>Pregnant patients with a diagnosis of Type I, Type II or gestational diabetes will be included in this arm. Blood will be drawn from each patient when they are hospitalized and before they deliver either vaginally or by cesarean section. Blood will be drawn into two citrate tubes, each will contain 4 ml blood. | Diagnostic Test: Diabetic pregnancy<br>* Blood samples will be drawn before delivery to evaluate Factor XII level.<br>|
| Non-diabetic pregnancy<br>Healthy non-diabetic pregnant patients will be included in this arm. Blood will be drawn from each patient when they are hospitalized and before they deliver either vaginally or by cesarean section. Blood will be drawn into two citrate tubes, each will contain 4 ml blood. | Diagnostic Test: Non-diabetic pregnancy<br>* Blood samples will be drawn before delivery to evaluate Factor XII level.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factor XII level | The primary outcome is to evaluate Factor XII level in diabetic pregnancies. If the investigators can prove that Factor XII, which has a mitogenic activity and can increase the risk for thrombosis, increases more in diabetic pregnancies in the future usage of Factor inhibitors may reduce macrosomia, thrombosis and the complications due to these conditions in diabetic pregnancies | Blood will be drawn when the patient is hospitalized before they deliver. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macrosmia | The secondary outcome is to prove that the increase of Factor XII level is higher diabetic pregnancies and this increase might have an effect on macrosomia. | Blood will be drawn when the patient is hospitalized before they deliver. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic pregnancies, Factor XII