Promising Bimarker Prediction of Outcome of HELLP Syndrome.
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|ClinicalTrials.gov Identifier: NCT03246542|
Recruitment Status : Completed
First Posted : August 11, 2017
Last Update Posted : August 11, 2017
AYMAN ABDELKADER MOHAMED ABDELKADER
Information provided by (Responsible Party):
AYMAN ABDELKADER MOHAMED ABDELKADER, Ain Shams Maternity Hospital
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.
|Condition or disease||Intervention/treatment|
|Pre-Eclampsia, Severe HELLP Syndrome Microangiopathy||Diagnostic Test: shistocytes percentage|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||100 participants|
|Target Follow-Up Duration:||2 Days|
|Official Title:||Association Between the Quantitative Assessment of Schistocytes in Peripheral Blood Smear and Prognosis of Patient Initially Diagnosed as HELLP Syndrome.|
|Actual Study Start Date :||January 1, 2015|
|Actual Primary Completion Date :||December 1, 2015|
|Actual Study Completion Date :||June 1, 2016|
Primary Outcome Measures :
- 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)
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