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Promising Bimarker Prediction of Outcome of HELLP Syndrome.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03246542
Recruitment Status : Completed
First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Information provided by (Responsible Party):

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 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

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 .

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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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 .


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 Documents (Full-Text)

Documents provided by AYMAN ABDELKADER MOHAMED ABDELKADER, Ain Shams Maternity Hospital:
Study Protocol  [PDF] September 1, 2014
Statistical Analysis Plan  [PDF] January 1, 2016

Additional Information:

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Responsible Party: AYMAN ABDELKADER MOHAMED ABDELKADER, doctor, Ain Shams Maternity Hospital Identifier: NCT03246542    
Other Study ID Numbers: AAMABDELKADER 4
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HELLP Syndrome
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications