Status:
COMPLETED
Promising Bimarker Prediction of Outcome of HELLP Syndrome.
Lead Sponsor:
AYMAN ABDELKADER MOHAMED ABDELKADER
Conditions:
Pre-Eclampsia, Severe
HELLP Syndrome
Eligibility:
FEMALE
20-40 years
Brief 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 pregn...
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; ...
Eligibility Criteria
Inclusion
- 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
- any non included criteria
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03246542
Start Date
January 1 2015
End Date
June 1 2016
Last Update
August 11 2017
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