The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage
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|ClinicalTrials.gov Identifier: NCT01916928|
Recruitment Status : Completed
First Posted : August 6, 2013
Results First Posted : February 2, 2015
Last Update Posted : March 13, 2017
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.
|Condition or disease|
|Circulating Cell Free Fetal DNA Intrauterine Fetal Demise Miscarriage|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||December 2014|
Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
- 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
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916928
|United States, District of Columbia|
|Medstar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Rita W Driggers, MD||Medstar Washington Hospital Center|