Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Diabetic Pregnancy; Complement System; Disorder
• Intervention / Treatment: Diagnostic test: Diabetic pregnancy; Diagnostic test: Non-diabetic pregnancy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Sariyer
    • Istanbul, Sariyer, Turkey, 34457
      • Acibadem Maslak Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

30 Pregnant patients with a diagnosis of Type I, Type II or gestational diabetes and 30 non-diabetic pregnant patients will be included in our trial.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic pregnancy; 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; Blood samples will be drawn before delivery to evaluate Factor XII level.
Non-diabetic pregnancy; 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; Blood samples will be drawn before delivery to evaluate Factor XII level.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Acibadem University
• Investigators: Study Director: Mete Gungor, Prof., Acibadem MAA University

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.bcp.2007.10.003. Epub 2007 Oct 7.
• Decrem Y, Rath G, Blasioli V, Cauchie P, Robert S, Beaufays J, Frere JM, Feron O, Dogne 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.
• 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. doi: 10.2174/187152509789105444.
• Renne T, Schmaier AH, Nickel KF, Blomback 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.
• Ozbasli E, Takmaz O, Karabuk E, Gungor M. Comparison of factor XII levels in gestational diabetes, fetal macrosomia, and healthy pregnancies. BMC Pregnancy Childbirth. 2020 Dec 2;20(1):752. doi: 10.1186/s12884-020-03455-0.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): December 27, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Diabetic pregnancies, Factor XII
• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy in Diabetics
• Other Study ID Numbers: ATADEK-2017/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No