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Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

NCT ID: NCT03583216

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-20

Study Completion Date

2018-11-30

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.

Conditions

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Diabetic Pregnancy Pregnancy Related Complement System; Disorder

Keywords

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Diabetic pregnancies, Factor XII

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Diabetic pregnancy

Intervention Type DIAGNOSTIC_TEST

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.

Non-diabetic pregnancy

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Diabetic pregnancy

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

Intervention Type DIAGNOSTIC_TEST

Non-diabetic pregnancy

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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Esra Ozbasli

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mete Gungor, Prof.

Role: STUDY_DIRECTOR

Acibadem MAA University

Locations

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Acibadem Maslak Hospital

Istanbul, Sariyer, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 17996217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19808248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19689262 (View on PubMed)

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.

Reference Type RESULT
PMID: 22993391 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33267793 (View on PubMed)

Other Identifiers

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ATADEK-2017/10

Identifier Type: -

Identifier Source: org_study_id