Pre-Eclampsia, SevereNCT03232359
Immature Platelet Fraction as a Promising Biomarker in Prediction Outcome of HELLP Syndrome
An observational study of Pre-Eclampsia, Severe and HELLP Syndrome, run by AYMAN ABDELKADER MOHAMED ABDELKADER.
Trial summary
Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is able to discriminate between patients with TTP/HUS or SPE/HELLP Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Severe, HELLP Syndrome, Microangiopathy
- What is being tested?
- immature platelets fraction
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jun 2016
- How long will I take part?
- 3 Weeks
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: SPE/HELLP group. This group included 24 pregnant women (gestational age of >20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome. Group 2: TTP/HUS group. This group included 13 pregnant women (gestational age of >20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS. Group 3: Control group. This group included 20 pregnant women (gestational age of >20 weeks) having normal pregnancy with normal blood pressure and platelet count.
Who may be able to join
- Older than 20 years of age
- Pregnant with singleton intrauterine pregnancy
- More than 20 weeks of gestation
Who cannot join
- Congenital malformation and fetuses with chromosomal or genetic syndrome.
- Recent blood transfusion.
- Refusal to participate in the study.
- BMI <18.
- Placental abnormalities like velamentous insertion.
- Multiple pregnancies.
- Known kidney disease.
- History of auto immune disease.
About this study
Official title: Assessment of Immature Platelet Fraction in Pregnancy-Associated Thrombotic Microangiopathy
Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is able to discriminate between patients with TTP/HUS or SPE/HELLP
Read the detailed description
Thrombotic microangiopathy (TMA) syndromes are extraordinarily diverse. Thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) are the two most well known, and are considered to be the most serious. TTP-HUS occurs more commonly in women and among women is commonly associated with pregnancy.
Nevertheless, there are other pregnancy conditions that may manifest with TMA, including preeclampsia, eclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), in addition to acute fatty liver of pregnancy, antiphospholipid syndrome, and systemic lupus erythematosis.
Assessment of immature platelets was introduced as a non-invasive test of real time thrombopoiesis. They are newly released in the circulation with a larger size \& greater RNA content than mature platelets, and can be measured by automated haematology analyzer equipped with reticulocyte detection channel and described as immature platelet fraction (%-IPF) and immature platelet count (A-IPC).
A high %-IPF has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption, while a low %-IPF is characteristic of bone marrow suppression states. %-IPF/A-IPF has the competency to be performed routinely and, therefore, can provide therapeutic and diagnostic feedback in the life threatening conditions.
The present study aimed to show the utility of estimating %-IPF and A-IPC using a reticulocyte detection channel CBC autoanalyzer as a simple reproducible blood analysis to be employed in the differential diagnosis of pregnancy-associated thrombotic microangiopathic conditions.
- Conditions
- Pre-Eclampsia, Severe, HELLP Syndrome, Microangiopathy
- Being tested
- immature platelets fraction
- Medical subject headings
- Pre-Eclampsia, HELLP Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immature platelets fractionDiagnostic test
IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer
| Study group | Role | What they receive |
|---|---|---|
| SPE/HELLP group | This group included 24 pregnant women (gestational age of >20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis Receives: Diagnostic Test: immature platelets fraction | |
| TTP/HUS group | This group included 13 pregnant women (gestational age of >20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS. HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis Receives: Diagnostic Test: immature platelets fraction | |
| Control group | This group included 20 pregnant women (gestational age of >20 weeks) having normal pregnancy with normal blood pressure and platelet count. Receives: Diagnostic Test: immature platelets fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response after delivery
clinical and laboratory changes after delivery
Measured: 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Jan 2015
- Primary completion1 Dec 2015
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Eclampsia, SevereStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- AYMAN ABDELKADER MOHAMED ABDELKADER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AYMAN ABDELKADER MOHAMED ABDELKADER, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232359
- Sponsor's protocol ID
- AAMABDELKADER 3
- Status last verified
- Jul 2017
- First submitted
- 23 Jul 2017
- Last updated
- 28 Jul 2017
- 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 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Immature Platelet Fraction in Pregnancy-Associated Thrombotic Microangiopathy
- ClinicalTrials.gov ID
- NCT03232359
- Acronym / sponsor ID
- AAMABDELKADER 3
- Conditions
- Pre-Eclampsia, Severe, HELLP Syndrome, Microangiopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AYMAN ABDELKADER MOHAMED ABDELKADERUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 28 Jul 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.
Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is able to discriminate between patients with TTP/HUS or SPE/HELLP
Detailed description
Thrombotic microangiopathy (TMA) syndromes are extraordinarily diverse. Thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) are the two most well known, and are considered to be the most serious. TTP-HUS occurs more commonly in women and among women is commonly associated with pregnancy.
Nevertheless, there are other pregnancy conditions that may manifest with TMA, including preeclampsia, eclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), in addition to acute fatty liver of pregnancy, antiphospholipid syndrome, and systemic lupus erythematosis.
Assessment of immature platelets was introduced as a non-invasive test of real time thrombopoiesis. They are newly released in the circulation with a larger size \& greater RNA content than mature platelets, and can be measured by automated haematology analyzer equipped with reticulocyte detection channel and described as immature platelet fraction (%-IPF) and immature platelet count (A-IPC).
A high %-IPF has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption, while a low %-IPF is characteristic of bone marrow suppression states. %-IPF/A-IPF has the competency to be performed routinely and, therefore, can provide therapeutic and diagnostic feedback in the life threatening conditions.
The present study aimed to show the utility of estimating %-IPF and A-IPC using a reticulocyte detection channel CBC autoanalyzer as a simple reproducible blood analysis to be employed in the differential diagnosis of pregnancy-associated thrombotic microangiopathic conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPE/HELLP group | – | Diagnostic Test: immature platelets fractionThis group included 24 pregnant women (gestational age of >20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis |
| TTP/HUS group | – | Diagnostic Test: immature platelets fractionThis group included 13 pregnant women (gestational age of >20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS. HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis |
| Control group | – | Diagnostic Test: immature platelets fractionThis group included 20 pregnant women (gestational age of >20 weeks) having normal pregnancy with normal blood pressure and platelet count. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: SPE/HELLP group. This group included 24 pregnant women (gestational age of >20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome. Group 2: TTP/HUS group. This group included 13 pregnant women (gestational age of >20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS. Group 3: Control group. This group included 20 pregnant women (gestational age of >20 weeks) having normal pregnancy with normal blood pressure and platelet count.
Key inclusion criteria (3 listed)
- Older than 20 years of age
- Pregnant with singleton intrauterine pregnancy
- More than 20 weeks of gestation
Key exclusion criteria (8 listed)
- Congenital malformation and fetuses with chromosomal or genetic syndrome.
- Recent blood transfusion.
- Refusal to participate in the study.
- BMI <18.
- Placental abnormalities like velamentous insertion.
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 |
|---|---|---|
| immature platelets fractionIPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer | Diagnostic test | Control group, SPE/HELLP group, TTP/HUS group |
Primary outcome
clinical response after delivery
Time frame: 48 hours after delivery
clinical and laboratory changes after delivery
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 28 Jul 2017.
- 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.
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 Pre-Eclampsia, Severe and HELLP Syndrome, run by AYMAN ABDELKADER MOHAMED ABDELKADER.
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 3 inclusion and 8 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 28 Jul 2017. 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?
clinical response after delivery (time frame: 48 hours after delivery). 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 28 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.