Recurrent Pregnancy Loss Clinical Trial
Official title:
Evaluation of Signal Peptide, Complement C1r/C1s, Uegf, and Bmp1 (CUB), and Epidermal Growth Factor-like Domain-containing Protein-1(SCUBE-1) Levels and Carotid Intima-Media Thickness in Unexplained Recurrent Pregnancy Loss
Clinical research will be carried out on two groups of patients. It will be performed on people with recurrent pregnancy loss and without a history of pregnancy loss. In two groups, blood samples will be assessed by elisa test, SCUBE-1 level and carotis intima media thickness will be evaluated by ultrasonographic measurement. It will be investigated whether there is a statistically significant difference between the two groups.A statistically significant difference in SCUBE-1 and carotid intima media thickness known as ischemia markers is expected in the group with recurrent pregnancy loss that could not be explained in the hypothesis of this planned study.
Status | Suspended |
Enrollment | 80 |
Est. completion date | June 23, 2022 |
Est. primary completion date | November 22, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: Patients with a history of two or more unexplained first trimester miscarriages Healthy women attending for antenatal care with at least one previous uneventful natural pregnancy. Women with normal pregnancy outcome and no previous pregnancy loss. Exclusion Criteria: No occurrence of hypertensive or diabetic disease of pregnancy. Pregnancies beyond the first trimester will be excluded from the study Pre-existing diabetes Vascular disease Antiphospholipid syndrome (APS) Genetic abnormality(chromosomal anomaly) Anatomic disorder Endocrinologic disorder Autoimmunologic disorder Ischemic diseases Diabetes mellitus Heart disease Hypertension Medical condition Multiple pregnancy Fetal anomaly current smokers |
Country | Name | City | State |
---|---|---|---|
Turkey | Recep Tayyip Erdogan University Faculty of Medicine, Department ofDepartment of Obstetrics and Gynecology | Rize |
Lead Sponsor | Collaborator |
---|---|
Recep Tayyip Erdogan University Training and Research Hospital |
Turkey,
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Carpenter M, Sinclair H, Kunadian V. Carotid Intima Media Thickness and Its Utility as a Predictor of Cardiovascular Disease: A Review of Evidence. Cardiol Rev. 2016 Mar-Apr;24(2):70-5. doi: 10.1097/CRD.0000000000000077. Review. — View Citation
Dai DF, Thajeb P, Tu CF, Chiang FT, Chen CH, Yang RB, Chen JJ. Plasma concentration of SCUBE1, a novel platelet protein, is elevated in patients with acute coronary syndrome and ischemic stroke. J Am Coll Cardiol. 2008 Jun 3;51(22):2173-80. doi: 10.1016/j.jacc.2008.01.060. — View Citation
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Tu CF, Yan YT, Wu SY, Djoko B, Tsai MT, Cheng CJ, Yang RB. Domain and functional analysis of a novel platelet-endothelial cell surface protein, SCUBE1. J Biol Chem. 2008 May 2;283(18):12478-88. doi: 10.1074/jbc.M705872200. Epub 2008 Feb 26. — View Citation
Xavier GM, Economou A, Senna Guimarães AL, Sharpe PT, Cobourne MT. Characterization of a mouse Scube3 reporter line. Genesis. 2010 Dec;48(12):684-92. doi: 10.1002/dvg.20678. Epub 2010 Nov 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the levels of scube1 in patients with recurrent pregnancy loss | Serum samples will be taken from all study group members. The study will be conducted with the given samples after routine assessment. 5 mL of maternal blood will be collected from the vein into tube, to be centrifuged within 1 h at 1000 g for 15 min. The plasma will be separated and stored at -80'C for analysis. Serum levels of SCUBE-1 will be quantified by ELISA using commercially available matched antibodies. | baseline | |
Secondary | Measurement of carotis intima media thickness by ultrasonography in recurrent pregnancy patients | A high-resolution 7.5 megahertz (MHz) linear array ultrasound transducer (Hitachi 6500) will be used to measure Carotid Intima-Media Thickness (CIMT). It will be measured from the far wall of the right carotid artery within 10 mm proximal to the bifurcation on two-dimensional ultrasound images. Three points will be measured on 1 scan, synchronized with the R-wave peaks on the ECG to avoid possible errors resulting from variable arterial compliance. Mean CIMT will be calculated from 6 measurements on 2 scans. Measurements will be repeated 2 days later in 10 control subjects. | baseline |
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