SCUBE-1 and Carotid Intima Media Thickness in Recurrent Pregnancy Loss

NCT04397042 | Suspended

• 1 other identifier: Recurrent Pregnancy Loss
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Pregnancy Loss

Keywords

recurrent pregnancy loss; unexplained; SCUBE-1; Carotis Intima-Media Thickness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement of carotis intima media thickness by ultrasonography in recurrent pregnancy patients

  baseline

Study Arms (1)

recurrent pregnancy loss

Group 1 included thirty women admitted to our clinic for termination of pregnancy due to absence of fetal cardiac activity or absence of fetal pole on ultrasonographic examination. Patients with a history of two or more unexplained first trimester miscarriages and no live births were included in the study

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will be conducted with the patients admitted to the obstetric and gynecologic clinic of Recep Tayyip Erdogan University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Recep Tayyip Erdogan University Faculty of Medicine, Department ofDepartment of Obstetrics and Gynecology

Rize, 53200, Turkey (Türkiye)

Location

Related Publications (10)

• Stephenson MD. Frequency of factors associated with habitual abortion in 197 couples. Fertil Steril. 1996 Jul;66(1):24-9.

  PMID: 8752606 BACKGROUND

• Greenwold N, Jauniaux E, Gulbis B, Hempstock J, Gervy C, Burton GJ. Relationship among maternal serum endocrinology, placental karyotype, and intervillous circulation in early pregnancy failure. Fertil Steril. 2003 Jun;79(6):1373-9. doi: 10.1016/s0015-0282(03)00364-9.

  PMID: 12798885 BACKGROUND

• 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.

  PMID: 18303018 BACKGROUND

• Xavier GM, Economou A, Senna Guimaraes 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.

  PMID: 20957652 BACKGROUND

• 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.

  PMID: 18510966 BACKGROUND

• Mensah GA. Healthy endothelium: the scientific basis for cardiovascular health promotion and chronic disease prevention. Vascul Pharmacol. 2007 May;46(5):310-4. doi: 10.1016/j.vph.2006.10.013. Epub 2006 Nov 21.

  PMID: 17229594 BACKGROUND

• Altin C, Yilmaz M, Ozsoy HM, Gezmis E, Balci S, Tekindal MA, Sade LE, Muderrisoglu H. Assessment of epicardial fat and carotid intima media thickness in gestational hypertension. J Obstet Gynaecol Res. 2018 Jun;44(6):1072-1079. doi: 10.1111/jog.13631. Epub 2018 Mar 30.

  PMID: 29603491 BACKGROUND

• 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.

  PMID: 26825762 BACKGROUND

• Lamarca B. The role of immune activation in contributing to vascular dysfunction and the pathophysiology of hypertension during preeclampsia. Minerva Ginecol. 2010 Apr;62(2):105-20.

  PMID: 20502423 BACKGROUND

• Prefumo F, Gaze DC, Papageorghiou AT, Collinson PO, Thilaganathan B. First trimester maternal serum ischaemia-modified albumin: a marker of hypoxia-ischaemia-driven early trophoblast development. Hum Reprod. 2007 Jul;22(7):2029-32. doi: 10.1093/humrep/dem095. Epub 2007 Apr 16.

  PMID: 17437959 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

Study Officials

• sabri colak, Asst.Prof.

  faculty of medicine recep tayyip erdogan university

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Sabri Colak,Department of Obstetrics and Gynecology, Recep Tayyip Erdogan University School of Medicine

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 21, 2020
• Study Start: May 22, 2020
• Primary Completion: November 22, 2021
• Study Completion: June 23, 2022
• Last Updated: May 12, 2021

Record last verified: 2021-05

Locations

TU (1)