Working… Menu

Immunoglobulins Anti Platelets In Breast Milk Of Maternal ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT01880801

Layout table for location information
Sharon Nechama, Laniado Hospital Not yet recruiting
Netanya, Israel
Contact: Nechama Sharone, MD    972-544303356   
Principal Investigator: Nechama Sharon, MD         
Sponsors and Collaborators
Laniado Hospital

Layout table for additonal information
Responsible Party: Laniado Hospital, pediatric hemato-oncology 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:
Additional relevant MeSH terms:
Layout table for MeSH terms
Immunologic Factors
Physiological Effects of Drugs