Ignite Creation Date:
2024-05-06 @ 2:41 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04397042
Status:
SUSPENDED
Last Update Posted:
2021-05-12
First Post:
2020-05-12
Brief Title:
SCUBE-1 and Carotid Intima Media Thickness in Recurrent Pregnancy Loss
Sponsor:
Recep Tayyip Erdogan University Training and Research Hospital
Organization:
Recep Tayyip Erdogan University Training and Research Hospital
Study Overview
Official Title:
Evaluation of Signal Peptide Complement C1rC1s Uegf and Bmp1 CUB and Epidermal Growth Factor-like Domain-containing Protein-1SCUBE-1 Levels and Carotid Intima-Media Thickness in Unexplained Recurrent Pregnancy Loss
Status:
SUSPENDED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 groupsA 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None