Promising Bimarker Prediction of Outcome of HELLP Syndrome.

August 9, 2017 updated by: AYMAN ABDELKADER MOHAMED ABDELKADER

Association Between the Quantitative Assessment of Schistocytes in Peripheral Blood Smear and Prognosis of Patient Initially Diagnosed as HELLP Syndrome.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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 .

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AYMAN ABDELKADER MOHAMED ABDELKADER

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAMABDELKADER 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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