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Completed

NCT Number: NCT03583216

Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

To compare Factor XII levels in gestational diabetic and healthy pregnancies.

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Key information

Conditions

Diabetic Pregnancy Complement System; Disorder Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Pregnancy Related Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Acibadem Maslak Hospital

Istanbul, Sariyer, 34457, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetic pregnancy

Diagnostic Test

Blood samples will be drawn before delivery to evaluate Factor XII level.

Non-diabetic pregnancy

Diagnostic Test

Blood samples will be drawn before delivery to evaluate Factor XII level.

Primary outcomes

  1. Factor XII level

    Time frame: Blood will be drawn when the patient is hospitalized before they deliver.

    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

Secondary outcomes

  1. Macrosmia

    Time frame: Blood will be drawn when the patient is hospitalized before they deliver.

    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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2018
Registry last updated
Dec 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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