Immature Platelet Fraction as a Promising Biomarker in Prediction Outcome of HELLP Syndrome

NCT03232359 | Completed

• 1 other identifier: AAMABDELKADER 3
• Study Type: observational
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is able to discriminate between patients with TTP/HUS or SPE/HELLP

Conditions

Pre-Eclampsia, Severe; HELLP Syndrome; Microangiopathy

Outcome Measures

Primary Outcomes (1)

• clinical response after delivery

  clinical and laboratory changes after delivery

  48 hours after delivery

Study Arms (3)

SPE/HELLP group

This group included 24 pregnant women (gestational age of \>20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis

Diagnostic Test: immature platelets fraction

TTP/HUS group

This group included 13 pregnant women (gestational age of \>20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS. HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis

Diagnostic Test: immature platelets fraction

Control group

This group included 20 pregnant women (gestational age of \>20 weeks) having normal pregnancy with normal blood pressure and platelet count.

Diagnostic Test: immature platelets fraction

Interventions

immature platelets fraction DIAGNOSTIC_TEST

IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer

Control group; SPE/HELLP group; TTP/HUS group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group 1: SPE/HELLP group. This group included 24 pregnant women (gestational age of \>20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome. Group 2: TTP/HUS group. This group included 13 pregnant women (gestational age of \>20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS. Group 3: Control group. This group included 20 pregnant women (gestational age of \>20 weeks) having normal pregnancy with normal blood pressure and platelet count.

You may qualify if:

• Older than 20 years of age
• Pregnant with singleton intrauterine pregnancy
• More than 20 weeks of gestation

You may not qualify if:

• Congenital malformation and fetuses with chromosomal or genetic syndrome.
• Recent blood transfusion.
• Refusal to participate in the study.
• BMI \<18.
• Placental abnormalities like velamentous insertion.
• Multiple pregnancies.
• Known kidney disease.
• History of auto immune disease.

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: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: July 28, 2017
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share