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Immunoglobulins Anti Platelets In Breast Milk Of Maternal ITP

IMMUNOGLOBULINS ANTI PLATELETS IN BREAST MILK OF MATERNAL ITP

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01880801
Enrollment
22
Registered
2013-06-19
Start date
2013-08-31
Completion date
2014-08-31
Last updated
2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mothers With ITP Condition

Keywords

ITP

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.

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.

Interventions

None listed

Sponsors

Laniado Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP4 times in the first month after delivery

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026