Recurrent Pregnancy LossNCT04397042
SCUBE-1 and Carotid Intima Media Thickness in Recurrent Pregnancy Loss
An observational study of Recurrent Pregnancy Loss, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Pregnancy Loss
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2020to 23 Jun 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will be conducted with the patients admitted to the obstetric and gynecologic clinic of Recep Tayyip Erdogan University Hospital.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Faculty of Medicine, Department ofDepartment of Obstetrics and Gynecology
Rize, 53200
About this study
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
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.
Read the 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.
- Conditions
- Recurrent Pregnancy Loss
- Keywords
- recurrent pregnancy loss, unexplained, SCUBE-1, Carotis Intima-Media Thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (1)
Measurement of carotis intima media thickness by ultrasonography in recurrent pregnancy patients
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start22 May 2020
- Primary completion22 Nov 2021 (estimated)
- Study completion23 Jun 2022 (estimated)
Why it stopped: pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Recurrent Pregnancy LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabri Colak, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- sabri colak, Asst.Prof., Study chair, faculty of medicine recep tayyip erdogan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397042
- Sponsor's protocol ID
- Recurrent Pregnancy Loss
- Status last verified
- May 2021
- First submitted
- 12 May 2020
- Last updated
- 12 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stephenson MD. Frequency of factors associated with habitual abortion in 197 couples. Fertil Steril. 1996 Jul;66(1):24-9.
PubMed 8752606Greenwold 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.
PubMed 12798885Tu 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.
PubMed 18303018Xavier 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.
PubMed 20957652Dai 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.
PubMed 18510966Mensah 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.
PubMed 17229594Altin 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.
PubMed 29603491Carpenter 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.
PubMed 26825762Lamarca 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.
PubMed 20502423Prefumo 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.
PubMed 17437959
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04397042
- Acronym / sponsor ID
- Recurrent Pregnancy Loss
- Conditions
- Recurrent Pregnancy Loss
- Keywords
- recurrent pregnancy loss, unexplained, SCUBE-1, Carotis Intima-Media Thickness
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: pandemic
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 22 Nov 2021 (estimated)
- Study completion
- 23 Jun 2022 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be conducted with the patients admitted to the obstetric and gynecologic clinic of Recep Tayyip Erdogan University Hospital.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the levels of scube1 in patients with recurrent pregnancy loss
Time frame: 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.
1 secondary outcome
Measurement of carotis intima media thickness by ultrasonography in recurrent pregnancy patients
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Background: PubMed 8752606Stephenson MD. Frequency of factors associated with habitual abortion in 197 couples. Fertil Steril. 1996 Jul;66(1):24-9.
- Background: PubMed 12798885Greenwold 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.
- Background: PubMed 18303018Tu 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.
- Background: PubMed 20957652Xavier 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.
- Background: PubMed 18510966Dai 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.
- Background: PubMed 17229594Mensah 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.
- Background: PubMed 29603491Altin 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.
- Background: PubMed 26825762Carpenter 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.
- Background: PubMed 20502423Lamarca 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.
- Background: PubMed 17437959Prefumo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sabri colak, Asst.Prof. study chair
faculty of medicine recep tayyip erdogan university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pregnancy Loss, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the levels of scube1 in patients with recurrent pregnancy loss (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04397042, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.