NCT01805102|Unknown
Correlation Between PIF Maternal Serum Levels and Pregnancy Outcome
PIFBlood1
Preimplantation Factor (PIF): Biomarker Detection in Maternal Blood - Correlation With Live Birth.
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PIFBlood1
Preimplantation Factor (PIF): Biomarker Detection in Maternal Blood - Correlation With Live Birth.
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · GFI-1
observational
500
3 countries
5
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedPIF: biomarker of pregnancy, miscarriage, premature birth, preeclampsia, placenta accreta. Except for serum hCG, no pregnancy-complication markers are widely employed to predict the need for medical intervention. Since circulating PIF is present from very early and throughout viable pregnancy, it may represent a specific biomarker candidate. PIF levels will be analyzed in serum of pregnant women in a range of settings: a) following IVF; b) index pregnancy of women with history of recurrent pregnancy loss, c) index pregnancy of women with history of placenta mediated complications such as: intrauterine growth restriction, spontaneous idiopathic preterm delivery, and preeclampsia; and d) index pregnancy in women with evidence of abnormal placentation, namely placenta accreta and related conditions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 1, 2013
Actual (reported)March 6, 2013
Actual (reported)August 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Maternal serum PIF levels correlation with pregnancy viability
Maternal blood will be collected serially following implantation. PIF levels will be recorded. Patients will be followed by standard methods including blood tests and ultrasound until viability is established. Implantation failure (ie chemical pregnancy) miscarriage, evidence of gestational sac will be recorded.
up to 12 weeks
Compare pregnancy outcome to low/high PIF levels in maternal blood
up to live birth
measurement by immunoassay
Women followed during pregnancy in perinatal centers
Yale Women and Children's Center for Blood Disorders & Yale Fertility Center
New Haven, Connecticut, 06511, United States
Poissy St Germain Hospital
Poissy, Cedex, 78303, France
Lab Clement - Seine St Denis Hospital, Le Blanc Mesnil
Paris, 93150, France
Versailles St Quentin University
Poissy, 2493, France
Helena Venizelou Hospital
Athens, 115 21, Greece
maternal blood
Eytan R Barnea, MD
BioIncept LLC
First Submitted
March 1, 2013
First Posted
March 6, 2013
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Estimated (date passed)Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 6, 2013
Record last verified: 2013-03
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Source: ClinicalTrials.gov.
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