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
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the levels of scube1 in patients with recurrent pregnancy loss
研究概览
简要总结
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.
详细描述
A total of 80 women who will apply to our obstetric clinic for early pregnancy loss or routine first trimester prenatal care will be included in the study. Patients will be divided into two groups. In Group 1, 40 women who applied to our clinic will be included due to the absence of fetal cardiac activity or fetal pole in ultrasonographic examination. Patients with two or more unexplained first trimester abortions and no live births will be included in the study. Pregnancies in the first trimester will be excluded. Group 2 will include 40 consecutive healthy women with at least one uneventful natural pregnancy for prenatal care in the first trimester. Women with normal pregnancy outcomes and no previous pregnancy loss will be included in the study. Patients who previously had diabetes or vascular disease will be excluded. The result of healthy pregnancy will be defined as delivery after 37 weeks, where the newborn birth weight was above the 10th percentile for pregnancy and no hypertensive or diabetic disease of pregnancy.
The gestational age for patients in the control group was calculated from the last menstrual period and will be verified by ultrasound examinations performed during the recording by trained ultrasonographers. It will be performed in the recurrent pregnancy loss (RPL) group according to the last menstrual period and previous sonography records of existing pregnancies without an existing fetal pole or intrauterine death. All results of term pregnancies for group 2, will be checked by reviewing the main delivery suit database and individual patient records A research protocol will be carried out to exclude known RPL relationships, such as antiphospholipid syndrome (APS) and an approved genetic abnormality. Recurrent abortions will include testing blood for diabetes, thyroid problems, autoimmune antibodies, coagulation factors, and parental karyotypes, and previous hysterosalpingography for abnormal uterine cavity. All couples diagnosed with chromosomal, anatomical, endocrinological and autoimmunological etiology of recurrent pregnancy loss will be excluded from group 1. Women with a history of ischemic disease, diabetes, heart disease, hypertension, or any known medical condition will not be recorded in two groups. Multiple pregnancy, any major or minor fetal anomaly, or existing smokers will also be excluded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
To evaluate the levels of scube1 in patients with recurrent pregnancy loss
时间窗: baseline
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.
次要结局
- Measurement of carotis intima media thickness by ultrasonography in recurrent pregnancy patients(baseline)
研究者
Sabri Colak
Asst. Prof. Sabri Colak,Department of Obstetrics and Gynecology, Recep Tayyip Erdogan University School of Medicine
Recep Tayyip Erdogan University Training and Research Hospital
