PreeclampsiaNCT03562715
microRNAs Role in Pre-eclampsia Diagnosis
An observational study of Preeclampsia, run by Cairo University.
Trial summary
Pre-eclampsia is one of the most threatening pregnancy complications. So far neither a secure, competent therapy for PE nor effective biomarkers for a premature discovery has been achieved.The aim of our study was to identify miRNAs 136, 494 and 495 genes expression in exosomes of peripheral blood compared to… Read more about this study
- Who is it for?
- Ages 23 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2016to 25 Dec 2017
- 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 23 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: PE group included 100 females with a mean age of 28.77 ± 5.72 years, while control group comprised of 100 females with a mean age of 28.06 ± 5.65 years. All enrolled patients were clinically diagnosed by physical examination and laboratory investigations.
Who may be able to join
- To have an uncomplicated pregnancy:
- gestational age at venipuncture between 20 - 42 weeks
- no medical, obstetrical, or surgical complications
- absence of labor at the time of venipuncture
- delivery of a normal term (≥ 37 weeks) neonate whose birth weight was between the 10th and 90th percentile for gestational age
Who cannot join
- Patients with chronic hypertension, renal disease, and fetuses affected with congenital anomalies were excluded
About this study
Official title: Role of Mesenchymal Stem Cells Exosomes Derived microRNAs; miR-136, miR-494 and miR-495 in Pre-eclampsia Diagnosis and Evaluation
Pre-eclampsia is one of the most threatening pregnancy complications. So far neither a secure, competent therapy for PE nor effective biomarkers for a premature discovery has been achieved.The aim of our study was to identify miRNAs 136, 494 and 495 genes expression in exosomes of peripheral blood compared to umbilical cord mesenchymal stem cells conditioned media released exososomes in patients with PE, as valuable markers for PE early prediction.
- Conditions
- Preeclampsia
- Keywords
- microRNAs, exosomes, preeclampsia, mesenchymal stem cells
- Medical subject headings
- Pre-Eclampsia
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 |
|---|---|---|
| Control group | Blood samples were collected from 100 control with normal pregnancies. Thirty fresh umbilical cord samples of women with healthy pregnancies (n=15) were retrieved during caesarean deliveries and umibilical cord mesenchymal stem cells (UCMSCs) were isolated from Wharton jelly. | |
| Preeclampsia group | Blood samples were collected from 100 patients with PE. Thirty fresh umbilical cord samples of PE patients (n=15) were retrieved during caesarean deliveries and UCMSCs were isolated from Wharton jelly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expression of miRNAs 136, 494 and 495 in exosomes of peripheral blood and UCMSCs conditioned media
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start28 Nov 2016
- Primary completion15 Jun 2017
- Study completion25 Dec 2017
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 Cairo 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine wagdi maurice, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562715
- Sponsor's protocol ID
- BC (1870)
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mesenchymal Stem Cells Exosomes Derived microRNAs; miR-136, miR-494 and miR-495 in Pre-eclampsia Diagnosis and Evaluation
- ClinicalTrials.gov ID
- NCT03562715
- Acronym / sponsor ID
- BC (1870)
- Conditions
- Preeclampsia
- Keywords
- microRNAs, exosomes, preeclampsia, mesenchymal stem cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 25 Dec 2017 (actual)
- First posted
- 19 Jun 2018 (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 one of the most threatening pregnancy complications. So far neither a secure, competent therapy for PE nor effective biomarkers for a premature discovery has been achieved.The aim of our study was to identify miRNAs 136, 494 and 495 genes expression in exosomes of peripheral blood compared to umbilical cord mesenchymal stem cells conditioned media released exososomes in patients with PE, as valuable markers for PE early prediction.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Blood samples were collected from 100 control with normal pregnancies. Thirty fresh umbilical cord samples of women with healthy pregnancies (n=15) were retrieved during caesarean deliveries and umibilical cord mesenchymal stem cells (UCMSCs) were isolated from Wharton jelly. |
| Preeclampsia group | – | –Blood samples were collected from 100 patients with PE. Thirty fresh umbilical cord samples of PE patients (n=15) were retrieved during caesarean deliveries and UCMSCs were isolated from Wharton jelly. |
Who may qualify
- Ages
- 23 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- PE group included 100 females with a mean age of 28.77 ± 5.72 years, while control group comprised of 100 females with a mean age of 28.06 ± 5.65 years. All enrolled patients were clinically diagnosed by physical examination and laboratory investigations.
Key inclusion criteria (5 listed)
- gestational age at venipuncture between 20 - 42 weeks
- no medical, obstetrical, or surgical complications
- absence of labor at the time of venipuncture
- delivery of a normal term (≥ 37 weeks) neonate whose birth weight was between the 10th and 90th percentile for gestational age
Key exclusion criteria (1 listed)
- Patients with chronic hypertension, renal disease, and fetuses affected with congenital anomalies were excluded
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
The expression of miRNAs 136, 494 and 495 in exosomes of peripheral blood and UCMSCs conditioned media
Time frame: 2-3 months
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 19 Jun 2018.
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Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Cairo University.
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 5 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The expression of miRNAs 136, 494 and 495 in exosomes of peripheral blood and UCMSCs conditioned media (time frame: 2-3 months). 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 19 Jun 2018.