Promising Bimarker Prediction of Outcome of HELLP Syndrome.

NCT03246542 | Completed

• 1 other identifier: AAMABDELKADER 4
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pre-Eclampsia, Severe; HELLP Syndrome; Microangiopathy

Outcome Measures

Primary Outcomes (1)

• laboratory changes after 48 hours of delivery

  full blood count, liver function tests( AST, ALT, Bilirubin), kidney function (serum creatinine level), coagulation profile (INR, PTT, PT)

  48 hours

Interventions

shistocytes percentage DIAGNOSTIC_TEST

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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 .

You may qualify if:

• 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..

Sponsors & Collaborators

• AYMAN ABDELKADER MOHAMED ABDELKADER: lead

MeSH Terms

Conditions

Pre-Eclampsia; HELLP Syndrome

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: August 11, 2017
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share