Immunoglobulins Anti Platelets In Breast Milk Of Maternal ITP

IMMUNOGLOBULINS ANTI PLATELETS IN BREAST MILK OF MATERNAL ITP

The purpose of this study is to determine whether mothers with Idiopathic thrombocytopenic purpura (ITP) has antibodies against platelets in breastfeeding milk aside control group of healthy mothers.

In order to prevent severe thrombocytopenia in infants born to mothers with ITP.

Study Overview

• Status: Unknown
• Conditions: Mothers With ITP Condition

Detailed Description

Samples of breastfeeding milk and sera will be collected from 10 lactating women diagnosed with ITP and from 10 healthy women in the same stage after giving birth. Antibodies against platelets in the samples will be examined by using anti human IgM/G/A antibody following incubation of the serum/milk samples with platelets. The platelets will be from leftovers of samples send to platelets functionality test and found to be normal (the platelets samples will be taken without any identification and be marked only with lab number). The measurement will be done by flow cytometer. Sample will be consider as positive when the signal will be greater than 2 fold of control samples standard deviation. In addition, the presence of antibodies in different times from the birth will be checked in breastfeeding milk and sera of ITP patients. If the milk proteins and lipids will disturb the exam, the immunoglobulins from the milk will be isolated using Ig isolation kit from plasma.

• Study Type: Observational
• Enrollment (Anticipated): 22

Contacts and Locations

Study Locations

• Israel
  • Netanya, Israel
    • Sharon Nechama, Laniado Hospital
    • Principal Investigator: Nechama Sharon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Lactating women diagnosed with ITP

Description

Inclusion Criteria:

• Maternal ITP
• Newborns above 35W and above 2.5 kg

Exclusion Criteria:

• mothers who do not breast feeding
• Thrombocytopenia from other reasons

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP	4 times in the first month after delivery

Collaborators and Investigators

• Sponsor: Laniado Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ANTICIPATED): August 1, 2014
• Study Completion (ANTICIPATED): August 1, 2014

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (ESTIMATE): June 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: ITP
• Other Study ID Numbers: 006-12-LND