SCUBE-1 and Carotid Intima Media Thickness in Recurrent Pregnancy Loss
- Conditions
- Recurrent Pregnancy Loss
- Registration Number
- NCT04397042
- Lead Sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 80
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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the levels of scube1 in patients with recurrent pregnancy loss 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.
- Secondary Outcome Measures
Name Time Method Measurement of carotis intima media thickness by ultrasonography in recurrent pregnancy patients baseline 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.
Trial Locations
- Locations (1)
Recep Tayyip Erdogan University Faculty of Medicine, Department ofDepartment of Obstetrics and Gynecology
🇹🇷Rize, Turkey