PreeclampsiaNCT03258125
miRNA-452 in Patients With Preeclampsia and Its Correlation With MMP-9
An observational study of Preeclampsia, run by Assiut University at 1 site in Egypt.
Trial summary
Preeclampsia is a pregnancy related disease characterized by the new onset of hypertension and proteinuria after 20 weeks of gestation in previously normotensive women. PE is one of the most challenging diseases in obstetrics worldwide that affects 2-8 % of pregnancies causing both morbidity and mortality of both… 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
- Preeclampsia
- What is being tested?
- real time PCR (rPCR)
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jun 2020
- 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: Pregnant women who come for termination of pregnancy by vaginal delivery or CS between 28-34 weaks gestational age in Assiut university maternity hospital in the age range of 18-40 years.
Who may be able to join
- Pregnant women who come for termination of pregnancy by vaginal delivery or CS between 28-34 weaks gestational age in Assiut university maternity hospital in the age range of 18-40 years.
Who cannot join
- 1) Diabetes mellitus 2) Chronic hypertension 3) Nephropathy 4) Acute or chronic infectious diseases or other chronic illness 5) Twins pregnancy 6) Anti phospholipid antibody syndrome 7) PE complicated with eclampsia, DIC or HELP syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expression of miRNA-452 in Patients With Early Onset Preeclampsia and Its Correlation With MMP-9
Preeclampsia is a pregnancy related disease characterized by the new onset of hypertension and proteinuria after 20 weeks of gestation in previously normotensive women. PE is one of the most challenging diseases in obstetrics worldwide that affects 2-8 % of pregnancies causing both morbidity and mortality of both mother and fetus.
Read the detailed description
The etiology and pathophysiology of preeclampsia are still unclear but the impaired invasive ability of the trophoblast cells of the placenta and vascular endothelial cell damage are the main two factors. The invasiveness of trophoblast cells depends on the production of proteases, particularly matrix metalloproteinases (MMP). MMPs are a family of 24 zinc dependent endopeptidases capable of degrading extra cellular matrix components. MMP-9 plays an important role in placental invasion and implantation.
MicroRNAs (miRs) are a class of small (19-24 nucleotides in length), single-stranded, non-protein-coding RNAs, which suppress translation or promote the degradation of target messenger RNAs (mRNAs) and thus play an important role in the regulation of cell proliferation, differentiation, apoptosis and even development of cancer.
The role of miRNA in preeclampsia pathogenesis has been investigated in a number of studies. One of the target areas of the miRNAs that forms a link with preeclampsia pathogenesis is the dysregulation of trophoblast differentiation, proliferation, and invasion; this occurs during early pregnancy and leads to the development of preeclampsia; a range of miRNAs have been confirmed to play pivotal roles in these processes by targeting a number of different genes.
MiR-452 is a newly discovered cancer related type of miRNA that was shown to be involved in invasion process where it was upregulated in certain types of cancer such as blad¬der cancer, urothelial carcinoma, and hepatocellular carcinoma and was found to be significantly decreased in other types of cancer such as non-small cell lung cancer , glioma, prostate cancer and Gastric cell cancer.
Based on these previous studies which demonstrate the effect of miR-452 in invasion process of cancer cells either by stimulation or inhibition and that preeclampsia is a disease of impaired placental invasion in which MMP-9 play an important role, we will investigate the placental tissues expression changes of miR-452 which is not studied yet in early onset preeclampsia patients compared to control and try to find a possible mechanism by which it act on placental invasion by measuring expression level of MMP-9 and making correlation between them. The results of this study will provide experimental and theo¬retical basis for clinical prediction, prevention and treatment of preeclampsia.
- Conditions
- Preeclampsia
- Being tested
- real time PCR (rPCR)
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real time PCR (rPCR)Genetic
A villus tissue (2.5 cm * 2.5 cm * 2.5 cm) will be cut off immediately from the center of placenta, avoiding the area of infarction, bleeding or calcification. After being washed with normal saline, the tissue will be preserved in liquid nitro¬gen at once for subsequent detection of miR-452 and MMP-9 expression by real time PCR (r-PCR). During this procedure total RNA will be extracted including miR-452 and mRNA of MMP-9. Then by reverse transcriptase RNA will be converted into DNA which will be amplification during the PCR, i.e. in real-time, and not at its end, as in conventional PCR. Expression of miR-452 and MMP-9 will be estimated and correlated with each other.
| Study group | Role | What they receive |
|---|---|---|
| severe EOPE | EOPE: PE starting before 34 weeks gestation Severe PE (Blood pressure more than 160/ 110 mm Hg on 2 occasions 2 hours to 2 weeks apart and proteinuria ( 24-hour urine protein >2000 mg/d). Receives: Genetic: real time PCR (rPCR) | |
| control | Healthy Pregnant women who come for termination of pregnancy by vaginal delivery or CS between 28-34 weeks gestational age. Receives: Genetic: real time PCR (rPCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of miRNA-452 and MMP-9.
real time polymerase chain reaction
Measured: one year
Secondary outcomes (1)
Differences in placental and neonatal weight between the two groups
weight the placenta and fetus in kilograms
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Jan 2019
- Primary completion1 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FYAli, Assiut University
- Investigators
- Ahmed Abbas, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258125
- Sponsor's protocol ID
- miR-452PE
- Status last verified
- Jun 2020
- First submitted
- 20 Aug 2017
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of miRNA-452 in Patients With Early Onset Preeclampsia and Its Correlation With MMP-9
- ClinicalTrials.gov ID
- NCT03258125
- Acronym / sponsor ID
- miR-452PE
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 23 Aug 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.
Preeclampsia is a pregnancy related disease characterized by the new onset of hypertension and proteinuria after 20 weeks of gestation in previously normotensive women. PE is one of the most challenging diseases in obstetrics worldwide that affects 2-8 % of pregnancies causing both morbidity and mortality of both mother and fetus.
Detailed description
The etiology and pathophysiology of preeclampsia are still unclear but the impaired invasive ability of the trophoblast cells of the placenta and vascular endothelial cell damage are the main two factors. The invasiveness of trophoblast cells depends on the production of proteases, particularly matrix metalloproteinases (MMP). MMPs are a family of 24 zinc dependent endopeptidases capable of degrading extra cellular matrix components. MMP-9 plays an important role in placental invasion and implantation.
MicroRNAs (miRs) are a class of small (19-24 nucleotides in length), single-stranded, non-protein-coding RNAs, which suppress translation or promote the degradation of target messenger RNAs (mRNAs) and thus play an important role in the regulation of cell proliferation, differentiation, apoptosis and even development of cancer.
The role of miRNA in preeclampsia pathogenesis has been investigated in a number of studies. One of the target areas of the miRNAs that forms a link with preeclampsia pathogenesis is the dysregulation of trophoblast differentiation, proliferation, and invasion; this occurs during early pregnancy and leads to the development of preeclampsia; a range of miRNAs have been confirmed to play pivotal roles in these processes by targeting a number of different genes.
MiR-452 is a newly discovered cancer related type of miRNA that was shown to be involved in invasion process where it was upregulated in certain types of cancer such as blad¬der cancer, urothelial carcinoma, and hepatocellular carcinoma and was found to be significantly decreased in other types of cancer such as non-small cell lung cancer , glioma, prostate cancer and Gastric cell cancer.
Based on these previous studies which demonstrate the effect of miR-452 in invasion process of cancer cells either by stimulation or inhibition and that preeclampsia is a disease of impaired placental invasion in which MMP-9 play an important role, we will investigate the placental tissues expression changes of miR-452 which is not studied yet in early onset preeclampsia patients compared to control and try to find a possible mechanism by which it act on placental invasion by measuring expression level of MMP-9 and making correlation between them. The results of this study will provide experimental and theo¬retical basis for clinical prediction, prevention and treatment of preeclampsia.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| severe EOPE | – | Genetic: real time PCR (rPCR)EOPE: PE starting before 34 weeks gestation Severe PE (Blood pressure more than 160/ 110 mm Hg on 2 occasions 2 hours to 2 weeks apart and proteinuria ( 24-hour urine protein >2000 mg/d). |
| control | – | Genetic: real time PCR (rPCR)Healthy Pregnant women who come for termination of pregnancy by vaginal delivery or CS between 28-34 weeks gestational age. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women who come for termination of pregnancy by vaginal delivery or CS between 28-34 weaks gestational age in Assiut university maternity hospital in the age range of 18-40 years.
Key inclusion criteria (1 listed)
- Pregnant women who come for termination of pregnancy by vaginal delivery or CS between 28-34 weaks gestational age in Assiut university maternity hospital in the age range of 18-40 years.
Key exclusion criteria (1 listed)
- 1) Diabetes mellitus 2) Chronic hypertension 3) Nephropathy 4) Acute or chronic infectious diseases or other chronic illness 5) Twins pregnancy 6) Anti phospholipid antibody syndrome 7) PE complicated with eclampsia, DIC or HELP syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real time PCR (rPCR)A villus tissue (2.5 cm * 2.5 cm * 2.5 cm) will be cut off immediately from the center of placenta, avoiding the area of infarction, bleeding or calcification. After being washed with normal saline, the tissue will be preserved in liquid nitro¬gen at once for subsequent detection of miR-452 and MMP-9 expression by real time PCR (r-PCR). During this procedure total RNA will be extracted including miR-452 and mRNA of MMP-9. Then by reverse transcriptase RNA will be converted into DNA which will be amplification during the PCR, i.e. in real-time, and not at its end, as in conventional PCR. Expression of miR-452 and MMP-9 will be estimated and correlated with each other. | Genetic | control, severe EOPE |
Primary outcome
Expression of miRNA-452 and MMP-9.
Time frame: one year
real time polymerase chain reaction
1 secondary outcome
Differences in placental and neonatal weight between the two groups
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: No
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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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.
Ahmed Abbas, MD study director
Assiut 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 Preeclampsia, run by Assiut University at 1 site 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 1 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: finished, as of the sponsor's last update on 24 Jun 2020. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Expression of miRNA-452 and MMP-9. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2020.