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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03232359
Other study ID # AAMABDELKADER 3
Secondary ID
Status Completed
Phase N/A
First received July 23, 2017
Last updated July 26, 2017
Start date January 1, 2015
Est. completion date June 1, 2016

Study information

Verified date July 2017
Source Ain Shams Maternity Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Description:

Thrombotic microangiopathy (TMA) syndromes are extraordinarily diverse. Thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) are the two most well known, and are considered to be the most serious. TTP-HUS occurs more commonly in women and among women is commonly associated with pregnancy.

Nevertheless, there are other pregnancy conditions that may manifest with TMA, including preeclampsia, eclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), in addition to acute fatty liver of pregnancy, antiphospholipid syndrome, and systemic lupus erythematosis.

Assessment of immature platelets was introduced as a non-invasive test of real time thrombopoiesis. They are newly released in the circulation with a larger size & greater RNA content than mature platelets, and can be measured by automated haematology analyzer equipped with reticulocyte detection channel and described as immature platelet fraction (%-IPF) and immature platelet count (A-IPC).

A high %-IPF has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption, while a low %-IPF is characteristic of bone marrow suppression states. %-IPF/A-IPF has the competency to be performed routinely and, therefore, can provide therapeutic and diagnostic feedback in the life threatening conditions.

The present study aimed to show the utility of estimating %-IPF and A-IPC using a reticulocyte detection channel CBC autoanalyzer as a simple reproducible blood analysis to be employed in the differential diagnosis of pregnancy-associated thrombotic microangiopathic conditions.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date June 1, 2016
Est. primary completion date December 1, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Older than 20 years of age

- Pregnant with singleton intrauterine pregnancy

- More than 20 weeks of gestation

Exclusion Criteria:

- 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.

Study Design


Intervention

Diagnostic Test:
immature platelets fraction
IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AYMAN ABDELKADER MOHAMED ABDELKADER

Outcome

Type Measure Description Time frame Safety issue
Primary clinical response after delivery clinical and laboratory changes after delivery 48 hours after delivery
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