Immunoglobulins Anti Platelets In Breast Milk Of Maternal ITP

Mothers With ITP Condition Clinical Trial

Official title:

IMMUNOGLOBULINS ANTI PLATELETS IN BREAST MILK OF MATERNAL ITP

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01880801
• Other study ID #: 006-12-LND
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2013
• Last updated: June 18, 2013
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2012
• Source: Laniado Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mothers With ITP Condition

Locations

Country	Name	City	State
Israel	Sharon Nechama, Laniado Hospital	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Laniado Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP		4 times in the first month after delivery	No