Pre-Eclampsia, SevereNCT03246542
Promising Bimarker Prediction of Outcome of HELLP Syndrome.
An observational study of Pre-Eclampsia, Severe and HELLP Syndrome, run by AYMAN ABDELKADER MOHAMED ABDELKADER.
Trial summary
HELLP syndrome is a life-threatening obstetric complication usually considered to be a variant or complication of pre-eclampsia. And may occasionally be confused with other diseases complicating pregnancy such as acute fatty liver of pregnancy, gastroenteritis, hepatitis, appendicitis, gallbladder disease, immune… 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, Severe, HELLP Syndrome, Microangiopathy
- What is being tested?
- shistocytes percentage
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jun 2016
- How long will I take part?
- 2 Days
- 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: A total of 100 women with an initial diagnosis of HELLP syndrome were recruited in the study. Blood sample taken within 12hrs peripartum and patients followed up 48hrs after delivery and subdivided in to 2 groups according to improvement or deterioration after 48hrs after delivery .
Who may be able to join
- Gestational age more than 20 weeks.
- Age from18 to 40 years old.
- Fulfilled criteria for the diagnosis of severe preeclampsia.
- Fulfilled criteria for the diagnosis of HELLP syndrome.
- Diagnostic criteria for severe preeclampsia(one of the following):
- Blood pressure of 160 mm Hg systolic or higher or 110 mm Hg diastolic or higher on two occasions at least 6 hours apart while the patient is on bed rest (unless antihypertensive therapy is intiated befor this time).
Show all 17Show fewer
- New onest Cerebral or visual disturbances.
- Pulmonary edema or cyanosis.
- Sever persistant epigastric or right upper-quadrant pain unresponsive to medication and not accounted for by alternative diagnosis, or both.
- Impaired liver function as indicated by abnormally elevated blood concentration of liver enzymes (to twic normal concentration).
- Thrombocytopenia (platlet count less than 100, 000 per microliter.
- Diagnostic criteria for HELLP syndrome:
- Hemolysis documented by an increased LDH level and progressive anemia .
- Hepatic dysfunction documented by an LDH level >600 IU/L, elevated liver enzymes documented by AST >40 IU/L, ALT>40 IU/L, or both .
- Thrombocytopenia documented by a platelet nadir less than 150, 000 cells/mm³. Thrombocytopenia is subclassified as class one HELLP syndrome: platelet nadir ≤50, 000 cells/mm³, class two HELLP syndrome: platelet nadir ≤100, 000 cells/mm³, or class three HELLP syndrome: platelet nadir ≤150, 000 cells/mm³..
- Anticepation of Microangiopathic Hemolytic Anemia:
- Thrombotic thrombocytopenic purpura-hemolytic uremic syndrome should be considered in all pregnant women with severe thrombocytopenia, severe anemia, and elevated lactate dehydrogenase enzyme.
Who cannot join
None listed.
About this study
Official title: Association Between the Quantitative Assessment of Schistocytes in Peripheral Blood Smear and Prognosis of Patient Initially Diagnosed as HELLP Syndrome.
HELLP syndrome is a life-threatening obstetric complication usually considered to be a variant or complication of pre-eclampsia. And may occasionally be confused with other diseases complicating pregnancy such as acute fatty liver of pregnancy, gastroenteritis, hepatitis, appendicitis, gallbladder disease, immune thrombocytopenia, lupus flare, antiphospholipid syndrome, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura, and nonalcoholic fatty liver disease. The distinction between thrombotic thrombocytopenic purpura-hemolytic uremic syndrome and severe preeclampsia is important for therapeutic and prognostic reasons. However, the clinical and histological features are so similar that establishing the correct diagnosis is often difficult; furthermore, these disorders may occur concurrently.
Read the detailed description
When TTP/HUS does occur during pregnancy, they often are confused initially with obstetric diagnoses such as severe preeclampsia; hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome; acute fatty liver of pregnancy; eclampsia, and antiphospholipid antibody syndrome. This might be related to the fact that the disease entity is rare and often is unexpected. Nevertheless, a delay in diagnosis of TTP/HUS may result in life-threatening maternal and fetal consequences. Aim of the current study was to compare the quantitative assessment of schistocytes in peripheral blood smear between women initially diagnosed as HELLP syndrome who showed no spontaneous resolution within 48 hrs after delivery and those who showed spontaneous resolution within 48 hrs after delivery which may help in decreasing the maternal mortality rate .
- Conditions
- Pre-Eclampsia, Severe, HELLP Syndrome, Microangiopathy
- Being tested
- shistocytes percentage
- 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.
shistocytes percentageDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
laboratory changes after 48 hours of delivery
full blood count, liver function tests( AST, ALT, Bilirubin), kidney function (serum creatinine level), coagulation profile (INR, PTT, PT)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 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
- 100 participants (actual)
- Target duration
- 2 Days
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
- NCT03246542
- Sponsor's protocol ID
- AAMABDELKADER 4
- Status last verified
- Aug 2017
- First submitted
- 23 Jul 2017
- Last updated
- 11 Aug 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 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Quantitative Assessment of Schistocytes in Peripheral Blood Smear and Prognosis of Patient Initially Diagnosed as HELLP Syndrome.
- ClinicalTrials.gov ID
- NCT03246542
- Acronym / sponsor ID
- AAMABDELKADER 4
- Conditions
- Pre-Eclampsia, Severe, HELLP Syndrome, Microangiopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 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
- 11 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.
HELLP syndrome is a life-threatening obstetric complication usually considered to be a variant or complication of pre-eclampsia. And may occasionally be confused with other diseases complicating pregnancy such as acute fatty liver of pregnancy, gastroenteritis, hepatitis, appendicitis, gallbladder disease, immune thrombocytopenia, lupus flare, antiphospholipid syndrome, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura, and nonalcoholic fatty liver disease. The distinction between thrombotic thrombocytopenic purpura-hemolytic uremic syndrome and severe preeclampsia is important for therapeutic and prognostic reasons. However, the clinical and histological features are so similar that establishing the correct diagnosis is often difficult; furthermore, these disorders may occur concurrently.
Detailed description
When TTP/HUS does occur during pregnancy, they often are confused initially with obstetric diagnoses such as severe preeclampsia; hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome; acute fatty liver of pregnancy; eclampsia, and antiphospholipid antibody syndrome. This might be related to the fact that the disease entity is rare and often is unexpected. Nevertheless, a delay in diagnosis of TTP/HUS may result in life-threatening maternal and fetal consequences. Aim of the current study was to compare the quantitative assessment of schistocytes in peripheral blood smear between women initially diagnosed as HELLP syndrome who showed no spontaneous resolution within 48 hrs after delivery and those who showed spontaneous resolution within 48 hrs after delivery which may help in decreasing the maternal mortality rate .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 100 women with an initial diagnosis of HELLP syndrome were recruited in the study. Blood sample taken within 12hrs peripartum and patients followed up 48hrs after delivery and subdivided in to 2 groups according to improvement or deterioration after 48hrs after delivery .
Key inclusion criteria (17 listed)
- Gestational age more than 20 weeks.
- Age from18 to 40 years old.
- Fulfilled criteria for the diagnosis of severe preeclampsia.
- Fulfilled criteria for the diagnosis of HELLP syndrome.
- Blood pressure of 160 mm Hg systolic or higher or 110 mm Hg diastolic or higher on two occasions at least 6 hours apart while the patient is on bed rest (unless antihypertensive therapy is intiated befor this time).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| shistocytes percentage | Diagnostic test | – |
Primary outcome
laboratory changes after 48 hours of delivery
Time frame: 48 hours
full blood count, liver function tests( AST, ALT, Bilirubin), kidney function (serum creatinine level), coagulation profile (INR, PTT, PT)
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 11 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia, Severe
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
Not yet recruitingPhase 4
Biomarkers in Management of Post Partum Preeclampsia
Preeclampsia Severe, Preeclampsia Postpartum
RecruitingPhase 4
Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
Preeclampsia, Preeclampsia Postpartum
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, 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 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 17 inclusion and 0 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 11 Aug 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?
laboratory changes after 48 hours of delivery (time frame: 48 hours). 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 11 Aug 2017.