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Immunoglobulins Anti Platelets In Breast Milk Of Maternal ITP

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ClinicalTrials.gov Identifier: NCT01880801
Recruitment Status : Unknown
Verified February 2012 by Laniado Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 19, 2013
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Laniado Hospital

Brief Summary:

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.


Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: IMMUNOGLOBULINS ANTI PLATELETS IN BREAST MILK OF MATERNAL ITP
Study Start Date : August 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014



Primary Outcome Measures :
  1. IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP [ Time Frame: 4 times in the first month after delivery ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Lactating women diagnosed with ITP
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880801


Locations
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Israel
Sharon Nechama, Laniado Hospital Not yet recruiting
Netanya, Israel
Contact: Nechama Sharone, MD    972-544303356    nsharon@laniado.org.il   
Principal Investigator: Nechama Sharon, MD         
Sponsors and Collaborators
Laniado Hospital

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Responsible Party: Laniado Hospital, pediatric hemato-oncology
ClinicalTrials.gov Identifier: NCT01880801     History of Changes
Other Study ID Numbers: 006-12-LND
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: February 2012
Keywords provided by Laniado Hospital:
ITP
Additional relevant MeSH terms:
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Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs