Clinical Trial: The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage

Brief Summary:

Women presenting to Washington Hospital Center with fetal loss would be offered participation in the study. The objective is to determine if ccffDNA obtained from maternal blood is present in the setting of missed abortion or fetal demise.

The investigators primary hypothesis is that cell free fetal DNA will be present in maternal blood in the presence of a failed pregnancy.


Detailed Summary:
Sponsor: Medstar Health Research Institute

Current Primary Outcome: The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy. [ Time Frame: During initial presentation for treatment ]

Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise


Original Primary Outcome: The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy. [ Time Frame: During initial presentation for treatment ]

Current Secondary Outcome: The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue. [ Time Frame: 3-4 weeks after specimen processing ]

Original Secondary Outcome: Same as current

Information By: Medstar Health Research Institute

Dates:
Date Received: August 2, 2013
Date Started: May 2013
Date Completion:
Last Updated: February 1, 2017
Last Verified: February 2017