Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

Pregnancy Related Clinical Trial

Official title:

Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583216
• Other study ID #: ATADEK-2017/10
• Status: Completed
• Start date: July 20, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: December 2018
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Complement System; Disorder
• Diabetic Pregnancy
• Pregnancy in Diabetics
• Pregnancy Related

Intervention

Diagnostic Test:
• Diabetic pregnancy
Blood samples will be drawn before delivery to evaluate Factor XII level.
• Non-diabetic pregnancy
Blood samples will be drawn before delivery to evaluate Factor XII level.

Locations

Country	Name	City	State
Turkey	Acibadem Maslak Hospital	Istanbul	Sariyer

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Bryant JW, Shariat-Madar Z. Human plasma kallikrein-kinin system: physiological and biochemical parameters. Cardiovasc Hematol Agents Med Chem. 2009 Jul;7(3):234-50. Review. — View Citation

Decrem Y, Rath G, Blasioli V, Cauchie P, Robert S, Beaufays J, Frère JM, Feron O, Dogné JM, Dessy C, Vanhamme L, Godfroid E. Ir-CPI, a coagulation contact phase inhibitor from the tick Ixodes ricinus, inhibits thrombus formation without impairing hemostasis. J Exp Med. 2009 Oct 26;206(11):2381-95. doi: 10.1084/jem.20091007. Epub 2009 Oct 5. — View Citation

Renné T, Schmaier AH, Nickel KF, Blombäck M, Maas C. In vivo roles of factor XII. Blood. 2012 Nov 22;120(22):4296-303. doi: 10.1182/blood-2012-07-292094. Epub 2012 Sep 19. Review. — View Citation

Schousboe I. Pharmacological regulation of factor XII activation may be a new target to control pathological coagulation. Biochem Pharmacol. 2008 Mar 1;75(5):1007-13. Epub 2007 Oct 7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.