Clinical trial NCT03583216: Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies
Official title: Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Pregnancy
Pregnancy Related
Complement System; Disorder
Keywords: Diabetic pregnancies, Factor XII
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Factor XII level
timeFrame: Blood will be drawn when the patient is hospitalized before they deliver.
Secondary outcomes:
measure: Macrosmia
timeFrame: Blood will be drawn when the patient is hospitalized before they deliver.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
state: Sariyer
Study officials:
affiliation: Acibadem MAA University
name: Mete Gungor, Prof.
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/j.bcp.2007.10.003. Epub 2007 Oct 7.
citation: 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.
citation: 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.
citation: 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.
citation: 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.