Mothers With ITP ConditionNCT01880801
Immunoglobulins Anti Platelets In Breast Milk Of Maternal ITP
An observational study of Mothers With ITP Condition, run by Laniado Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mothers With ITP Condition
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Lactating women diagnosed with ITP
Who may be able to join
- Maternal ITP
- Newborns above 35W and above 2.5 kg
Who cannot join
- mothers who do not breast feeding
- Thrombocytopenia from other reasons
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sharon Nechama, Laniado Hospital
Netanya, Israel
Nechama Sharone, MD, 972-544303356, nsharon@laniado.org.il
Nechama Sharon, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Mothers With ITP Condition
- Keywords
- ITP
What is being measured
The primary outcome is the main question the study is designed to answer.
IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP
Measured: 4 times in the first month after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mothers With ITP ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laniado Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laniado Hospital, Laniado Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880801
- Sponsor's protocol ID
- 006-12-LND
- Status last verified
- Feb 2012
- First submitted
- 17 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMUNOGLOBULINS ANTI PLATELETS IN BREAST MILK OF MATERNAL ITP
- ClinicalTrials.gov ID
- NCT01880801
- Acronym / sponsor ID
- 006-12-LND
- Conditions
- Mothers With ITP Condition
- Keywords
- ITP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Laniado HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Lactating women diagnosed with ITP
Key inclusion criteria (2 listed)
- Maternal ITP
- Newborns above 35W and above 2.5 kg
Key exclusion criteria (2 listed)
- mothers who do not breast feeding
- Thrombocytopenia from other reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP
Time frame: 4 times in the first month after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mothers With ITP Condition, run by Laniado Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP (time frame: 4 times in the first month after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.