The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage
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.
Circulating Cell Free Fetal DNA
Intrauterine Fetal Demise
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood collection will consist of two ten milliliters samples of whole blood in the cffDNA STRECK tube. Plasma will be retained for analysis of circulating cell free fetal DNA.
|Study Start Date:||May 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|