Pre-EclampsiaNCT03193554
Diagnostic Value of MicroRNA 210 In Preeclampsia
An observational study of Pre-Eclampsia, run by Assiut University at 2 sites in Egypt.
Trial summary
Pre-eclampsia is a disorder of pregnancy characterized by hypertension (defined as systolic blood pressure 140mmHg or diastolic blood pressure ⩾90 mmHg) and proteinuria (300 mg or greater in a 24 h urine specimen and/or protein to creatinine ratio of > 0.30) . Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2019to 30 Aug 2020
- How long will I take part?
- 3 Months
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women in second trimster divided into 2 groups : 1. Physiological high risk factor for preeclampsia . 2. Pregnant women with high insulin resistance.
Who may be able to join
None listed.
Who cannot join
- 1- Female patients with any other type of malignant or benign tumours should be excluded from our study.
- 2- Past history of chemotherapy or surgical treatment of cancer. 3-Women who diagnosed as preeclamptic or diabetic
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
ASSIUT University
Asyut
Lobna
- Recruiting
Assiut Unversity
Asyut
Lobna
About this study
Official title: Diagnostic Value of microRNA 210 In Preeclampsia
Pre-eclampsia is a disorder of pregnancy characterized by hypertension (defined as systolic blood pressure 140mmHg or diastolic blood pressure ⩾90 mmHg) and proteinuria (300 mg or greater in a 24 h urine specimen and/or protein to creatinine ratio of > 0.30) . The disorder usually occurs after 20 weeks of pregnancy and worsens over time. Risk factors for pre-eclampsia include: obesity, prior hypertension, older age, and diabetes mellitus, primigravida and pregnant women with multiple gestation .
Healthy women pregnancy can be associated with resistance to the action of insulin on glucose uptake and utilization. Insulin Resistance (IR) is defined as decreased ability of target tissues such as liver, adipose tissue and muscle to respond to normal circulating concentrations of insulin. Insulin Resistance can be a result of a number of factors such as defective molecular structure of insulin, defective receptor functioning or defective signal transduction pathway .
Read more
Preeclampsia is associated with increased expression of Tumor necrosis Factor α and other inflammatory marker which causes Insulin Resistance. Increased Insulin Resistance leads to dyslipidemia that can worsen the placental ischemia leading to vicious cycle of ischemia-inflammation-Insulin Resistance-dyslipidemia-ischemia . Insulin resistance has also been hypothesized to contribute to the pathophysiology of preeclampsia. Compared to women who have normotensive pregnancies, women who develop preeclampsia are more insulin resistant prior to pregnancy .
The recognition that specific miRNAs are induced by hypoxia and are commonly dysregulated in preeclampsia raises the possibility that such miRNAs mediate the adverse effects of placental hypoxia in preeclampsia. MiRNAs present in maternal blood may have the potential to be used as biomarkers, as they are relatively stable and tissue specific . It was found that mir-210 is induced in patients with pre-eclampsia, whether mir-210 contributes to the pathogenesis of pre-eclampsia, a complex disorder widely believed to be associated with placental hypoxia .
Read the detailed description
Pre-eclampsia is a disorder of pregnancy characterized by hypertension (defined as systolic blood pressure ⩾140 mmHg or diastolic blood pressure ⩾90 mmHg) and proteinuria (300 mg or greater in a 24 h urine specimen and/or protein to creatinine ratio of > 0.30) . The disorder usually occurs after 20 weeks of pregnancy and worsens over time . Preeclampsia is routinely screened during prenatal care .
In severe disease there may be red blood cell breakdown, a low blood platelet count, impaired liver function, kidney dysfunction, swelling, shortness of breath due to fluid in the lungs, or visual disturbances. Pre-eclampsia increases the risk of poor outcomes for both the mother and the baby . If left untreated, it may result in seizures at which point it is known as eclampsia or HELLP syndrome (hemolysis ,elevated liver enzymes , low platelets ) .
The clinical features of preeclampsia are caused by systemic maternal endothelial dysfunction resulting from a combination of preexisting maternal risk factors and abnormal placental development. Risk factors for pre-eclampsia include: obesity, prior hypertension, older age, and diabetes mellitus . It is also more frequent in a woman's first pregnancy and if she is carrying twins. The underlying mechanism involves abnormal formation of blood vessels in the placenta amongst other factors .
These maternal characteristics may contribute to oxidative stress, inflammation and vascular dysfunction, all of which have been implicated in the etiology of preeclampsia .
Healthy women pregnancy can be associated with resistance to the action of insulin on glucose uptake and utilization . Insulin Resistance is defined as decreased ability of target tissues such as liver, adipose tissue and muscle to respond to normal circulating concentrations of insulin. Insulin Resistance can be a result of a number of factors such as defective molecular structure of insulin, defective receptor functioning or defective signal transduction pathway .
Many maternal hormones and factors play role in causation of Insulin Resistance during pregnancy such as increased levels of serum cortisol, Tumor necrosis factor α , can interrupt the insulin signaling pathway and can lead to Insulin Resistance during normal pregnancy .
Women with increased Insulin Resistance are more prone to develop preeclampsia and gestational diabetes. Preeclampsia is associated with increased expression of Tumor necrosis factor α and other inflammatory marker which causes Insulin Resistance. Increased Insulin Resistance leads to dyslipidemia that can worsen the placental ischemia leading to vicious cycle of ischemia-inflammation-Insulin Resistance-dyslipidemia-ischemia .
Insulin resistance has also been hypothesized to contribute to the pathophysiology of preeclampsia. Compared to women who have normotensive pregnancies, women who develop preeclampsia are more insulin resistant prior to pregnancy .
Early reliable markers for preeclampsia development is the involvement of microRNA in the pathogenesis and its possible role as an early biomarker for disease development. MicroRNAs (miRNAs) are a series of small (18-24 nt) endogenous noncoding single-stranded RNAs, which can regulate gene expression post transcriptionally by a nonperfect pairing of 6-8 nucleotides with target mRNAs . It is currently estimated that up to 30% of human genes may contain miRNAs' binding sites, which suggested a potential role of microRNAs as central regulators in the control of gene expression .
MicroRNAs have been implicated in a variety of human diseases, such as cardiovascular disease, primary muscular disorders, and cancer. In addition, miRNAs have been reported involved in regulating pregnancy process .
The human placenta exhibits a specific microRNA expression pattern that dynamically changes during pregnancy and is reflected in the maternal plasma .
The recognition that specific microRNAs are induced by hypoxia and are commonly dysregulated in preeclampsia raises the intriguing possibility that such microRNAs mediate the adverse effects of placental hypoxia in preeclampsia. The connection between microRNAs, adipose tissue, and insulin resistance may have a role in gestational diabetes mellitus pathophysiology. microRNAs present in maternal blood may have the potential to be used as biomarkers, as they are relatively stable and tissue specific .
MicroRNA 210 is identified as a unique hypoxia induced miRNA that is universally induced in various cell types. Using microRNA microarray it was found that microRNA 210 is overexpressed in placental tissue derived from patients with pre-eclampsia .
It was found whether microRNA 210 contributes to the pathogenesis of pre-eclampsia, a complex disorder widely believed to be associated with placental hypoxia. The results show that microRNA 210 is induced in patients with pre-eclampsia and in hypoxia treated trophoblast cells .
It has been found that microRNA 210 levels are dramatically increased in the placental tissue derived from patients with preeclampsia. In this issue, MicroRNA 210 levels in plasma from preeclampsia patients were significantly higher than those in gestational healthy controls. Furthermore, the expression levels of microRNA 210 seemed to correlate well with disease severity, suggesting a potential role of circulating microRNA 210 as novel biomarker for the diagnosis of preeclampsia.
- Conditions
- Pre-Eclampsia
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of MicroRNA 210 in preeclampsia
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Jan 2019
- Primary completion1 May 2020
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra M Farghaly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193554
- Sponsor's protocol ID
- D V O MicroRNA210 I PET
- Status last verified
- May 2020
- First submitted
- 18 Jun 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Jameil N, Aziz Khan F, Fareed Khan M, Tabassum H. A brief overview of preeclampsia. J Clin Med Res. 2014 Feb;6(1):1-7. doi: 10.4021/jocmr1682w. Epub 2013 Dec 13.
PubMed 24400024Bueno MJ, Perez de Castro I, Malumbres M. Control of cell proliferation pathways by microRNAs. Cell Cycle. 2008 Oct;7(20):3143-8. doi: 10.4161/cc.7.20.6833. Epub 2008 Oct 20.
PubMed 18843198Eiland E, Nzerue C, Faulkner M. Preeclampsia 2012. J Pregnancy. 2012;2012:586578. doi: 10.1155/2012/586578. Epub 2012 Jul 11.
PubMed 22848831Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
PubMed 24150027Morales Prieto DM, Markert UR. MicroRNAs in pregnancy. J Reprod Immunol. 2011 Mar;88(2):106-11. doi: 10.1016/j.jri.2011.01.004. Epub 2011 Feb 25.
PubMed 21353310Roberts JM, Lain KY. Recent Insights into the pathogenesis of pre-eclampsia. Placenta. 2002 May;23(5):359-72. doi: 10.1053/plac.2002.0819.
PubMed 12061851Steegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2.
PubMed 20598363
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of microRNA 210 In Preeclampsia
- ClinicalTrials.gov ID
- NCT03193554
- Acronym / sponsor ID
- D V O MicroRNA210 I PET
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 21 Jun 2017 (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.
Pre-eclampsia is a disorder of pregnancy characterized by hypertension (defined as systolic blood pressure 140mmHg or diastolic blood pressure ⩾90 mmHg) and proteinuria (300 mg or greater in a 24 h urine specimen and/or protein to creatinine ratio of > 0.30) . The disorder usually occurs after 20 weeks of pregnancy and worsens over time. Risk factors for pre-eclampsia include: obesity, prior hypertension, older age, and diabetes mellitus, primigravida and pregnant women with multiple gestation .
Healthy women pregnancy can be associated with resistance to the action of insulin on glucose uptake and utilization. Insulin Resistance (IR) is defined as decreased ability of target tissues such as liver, adipose tissue and muscle to respond to normal circulating concentrations of insulin. Insulin Resistance can be a result of a number of factors such as defective molecular structure of insulin, defective receptor functioning or defective signal transduction pathway .
Preeclampsia is associated with increased expression of Tumor necrosis Factor α and other inflammatory marker which causes Insulin Resistance. Increased Insulin Resistance leads to dyslipidemia that can worsen the placental ischemia leading to vicious cycle of ischemia-inflammation-Insulin Resistance-dyslipidemia-ischemia . Insulin resistance has also been hypothesized to contribute to the pathophysiology of preeclampsia. Compared to women who have normotensive pregnancies, women who develop preeclampsia are more insulin resistant prior to pregnancy .
The recognition that specific miRNAs are induced by hypoxia and are commonly dysregulated in preeclampsia raises the possibility that such miRNAs mediate the adverse effects of placental hypoxia in preeclampsia. MiRNAs present in maternal blood may have the potential to be used as biomarkers, as they are relatively stable and tissue specific . It was found that mir-210 is induced in patients with pre-eclampsia, whether mir-210 contributes to the pathogenesis of pre-eclampsia, a complex disorder widely believed to be associated with placental hypoxia .
Detailed description
Pre-eclampsia is a disorder of pregnancy characterized by hypertension (defined as systolic blood pressure ⩾140 mmHg or diastolic blood pressure ⩾90 mmHg) and proteinuria (300 mg or greater in a 24 h urine specimen and/or protein to creatinine ratio of > 0.30) . The disorder usually occurs after 20 weeks of pregnancy and worsens over time . Preeclampsia is routinely screened during prenatal care .
In severe disease there may be red blood cell breakdown, a low blood platelet count, impaired liver function, kidney dysfunction, swelling, shortness of breath due to fluid in the lungs, or visual disturbances. Pre-eclampsia increases the risk of poor outcomes for both the mother and the baby . If left untreated, it may result in seizures at which point it is known as eclampsia or HELLP syndrome (hemolysis ,elevated liver enzymes , low platelets ) .
The clinical features of preeclampsia are caused by systemic maternal endothelial dysfunction resulting from a combination of preexisting maternal risk factors and abnormal placental development. Risk factors for pre-eclampsia include: obesity, prior hypertension, older age, and diabetes mellitus . It is also more frequent in a woman's first pregnancy and if she is carrying twins. The underlying mechanism involves abnormal formation of blood vessels in the placenta amongst other factors .
These maternal characteristics may contribute to oxidative stress, inflammation and vascular dysfunction, all of which have been implicated in the etiology of preeclampsia .
Healthy women pregnancy can be associated with resistance to the action of insulin on glucose uptake and utilization . Insulin Resistance is defined as decreased ability of target tissues such as liver, adipose tissue and muscle to respond to normal circulating concentrations of insulin. Insulin Resistance can be a result of a number of factors such as defective molecular structure of insulin, defective receptor functioning or defective signal transduction pathway .
Many maternal hormones and factors play role in causation of Insulin Resistance during pregnancy such as increased levels of serum cortisol, Tumor necrosis factor α , can interrupt the insulin signaling pathway and can lead to Insulin Resistance during normal pregnancy .
Women with increased Insulin Resistance are more prone to develop preeclampsia and gestational diabetes. Preeclampsia is associated with increased expression of Tumor necrosis factor α and other inflammatory marker which causes Insulin Resistance. Increased Insulin Resistance leads to dyslipidemia that can worsen the placental ischemia leading to vicious cycle of ischemia-inflammation-Insulin Resistance-dyslipidemia-ischemia .
Insulin resistance has also been hypothesized to contribute to the pathophysiology of preeclampsia. Compared to women who have normotensive pregnancies, women who develop preeclampsia are more insulin resistant prior to pregnancy .
Early reliable markers for preeclampsia development is the involvement of microRNA in the pathogenesis and its possible role as an early biomarker for disease development. MicroRNAs (miRNAs) are a series of small (18-24 nt) endogenous noncoding single-stranded RNAs, which can regulate gene expression post transcriptionally by a nonperfect pairing of 6-8 nucleotides with target mRNAs . It is currently estimated that up to 30% of human genes may contain miRNAs' binding sites, which suggested a potential role of microRNAs as central regulators in the control of gene expression .
MicroRNAs have been implicated in a variety of human diseases, such as cardiovascular disease, primary muscular disorders, and cancer. In addition, miRNAs have been reported involved in regulating pregnancy process .
The human placenta exhibits a specific microRNA expression pattern that dynamically changes during pregnancy and is reflected in the maternal plasma .
The recognition that specific microRNAs are induced by hypoxia and are commonly dysregulated in preeclampsia raises the intriguing possibility that such microRNAs mediate the adverse effects of placental hypoxia in preeclampsia. The connection between microRNAs, adipose tissue, and insulin resistance may have a role in gestational diabetes mellitus pathophysiology. microRNAs present in maternal blood may have the potential to be used as biomarkers, as they are relatively stable and tissue specific .
MicroRNA 210 is identified as a unique hypoxia induced miRNA that is universally induced in various cell types. Using microRNA microarray it was found that microRNA 210 is overexpressed in placental tissue derived from patients with pre-eclampsia .
It was found whether microRNA 210 contributes to the pathogenesis of pre-eclampsia, a complex disorder widely believed to be associated with placental hypoxia. The results show that microRNA 210 is induced in patients with pre-eclampsia and in hypoxia treated trophoblast cells .
It has been found that microRNA 210 levels are dramatically increased in the placental tissue derived from patients with preeclampsia. In this issue, MicroRNA 210 levels in plasma from preeclampsia patients were significantly higher than those in gestational healthy controls. Furthermore, the expression levels of microRNA 210 seemed to correlate well with disease severity, suggesting a potential role of circulating microRNA 210 as novel biomarker for the diagnosis of preeclampsia.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women in second trimster divided into 2 groups : 1. Physiological high risk factor for preeclampsia . 2. Pregnant women with high insulin resistance.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 1- Female patients with any other type of malignant or benign tumours should be excluded from our study.
- 2- Past history of chemotherapy or surgical treatment of cancer. 3-Women who diagnosed as preeclamptic or diabetic
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
Diagnostic value of MicroRNA 210 in preeclampsia
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Background: PubMed 24400024Al-Jameil N, Aziz Khan F, Fareed Khan M, Tabassum H. A brief overview of preeclampsia. J Clin Med Res. 2014 Feb;6(1):1-7. doi: 10.4021/jocmr1682w. Epub 2013 Dec 13.
- Background: PubMed 18843198Bueno MJ, Perez de Castro I, Malumbres M. Control of cell proliferation pathways by microRNAs. Cell Cycle. 2008 Oct;7(20):3143-8. doi: 10.4161/cc.7.20.6833. Epub 2008 Oct 20.
- Background: PubMed 22848831Eiland E, Nzerue C, Faulkner M. Preeclampsia 2012. J Pregnancy. 2012;2012:586578. doi: 10.1155/2012/586578. Epub 2012 Jul 11.
- Background: PubMed 24150027Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Background: PubMed 21353310Morales Prieto DM, Markert UR. MicroRNAs in pregnancy. J Reprod Immunol. 2011 Mar;88(2):106-11. doi: 10.1016/j.jri.2011.01.004. Epub 2011 Feb 25.
- Background: PubMed 12061851Roberts JM, Lain KY. Recent Insights into the pathogenesis of pre-eclampsia. Placenta. 2002 May;23(5):359-72. doi: 10.1053/plac.2002.0819.
- Background: PubMed 20598363Steegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Assiut University at 2 sites in Egypt.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Contact Lubna Tag El-din, MD (01001085510, Lubna_tag@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value of MicroRNA 210 in preeclampsia (time frame: 1 Year). 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 NCT03193554, which also lists 7 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 2020.