Promising Bimarker Prediction of Outcome of HELLP Syndrome.

NCT ID: NCT03246542

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2016-06-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

shistocytes percentage

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

AYMAN ABDELKADER MOHAMED ABDELKADER

OTHER

Sponsor Role: lead

Responsible Party

AYMAN ABDELKADER MOHAMED ABDELKADER

doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AAMABDELKADER 4

Identifier Type: -

Identifier Source: org_study_id