Clinical trial NCT04397042: SCUBE-1 and Carotid Intima Media Thickness in Recurrent Pregnancy Loss
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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Recurrent Pregnancy Loss
Keywords: recurrent pregnancy loss
unexplained
SCUBE-1
Carotis Intima-Media Thickness
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the levels of scube1 in patients with recurrent pregnancy loss
timeFrame: baseline
Secondary outcomes:
measure: Measurement of carotis intima media thickness by ultrasonography in recurrent pregnancy patients
timeFrame: baseline
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Faculty of Medicine, Department ofDepartment of Obstetrics and Gynecology
Study officials:
affiliation: faculty of medicine recep tayyip erdogan university
name: sabri colak, Asst.Prof.
role: STUDY_CHAIR
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