NCT01880801

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 19, 2013

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

June 17, 2013

Last Update Submit

June 18, 2013

Conditions

Mothers With ITP Condition

Keywords

ITP

Outcome Measures

Primary Outcomes (1)

  • IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP

    4 times in the first month after delivery

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Lactating women diagnosed with ITP

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharon Nechama, Laniado Hospital

Netanya, Israel, Israel

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pediatric hemato-oncology

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 19, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 19, 2013

Record last verified: 2012-02

Locations

IL(1)