- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03246542
Promising Bimarker Prediction of Outcome of HELLP Syndrome.
Association Between the Quantitative Assessment of Schistocytes in Peripheral Blood Smear and Prognosis of Patient Initially Diagnosed as HELLP Syndrome.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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 .
Description
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria: any non included criteria
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
48 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAMABDELKADER 4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HELLP Syndrome
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Cedars-Sinai Medical CenterAlexion Pharmaceuticals, Inc.TerminatedPregnancy Related | Preeclampsia | HELLP Syndrome | Severe Preeclampsia | HELLP | Complement Regulatory Factor Defect | PNH | Eculizumab | HELLP Syndrome Second Trimester | AHUS | Complement Abnormality | HELLP Syndrome Third TrimesterUnited States
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AYMAN ABDELKADER MOHAMED ABDELKADERCompletedHELLP Syndrome | Microangiopathy | Pre-Eclampsia, Severe
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