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

Completed

• Conditions: Circulating Cell Free Fetal DNA; Miscarriage; Intrauterine Fetal Demise

• Registration Number: NCT01916928
• Lead Sponsor: Medstar Health Research Institute

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 Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-06
• Primary Completion: 2014-01
• Study Completion: 2014-12
• Results First Submitted: 2014-12-31
• Results First Submitted QC: 2015-01-29
• Results First Posted: 2015-02-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Women diagnosed with Intrauterine fetal demised or missed abortion

Exclusion Criteria

• Patients diagnosed with threatened abortion with cardiac activity present
• Patients with IUFD who have delivered the fetus (the induction process may already be in process, however, the fetus and placenta must be in situ at the time of blood sampling)
• Patients with known genetic abnormalities or mental retardation as a result of chromosomal abnormalities 13, 18, 21, or sex chromosomes.
• Children under the age of 18
• Patients not fluent in or unable to consent to the study in English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy.	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

Secondary Outcome Measures

Name	Time	Method
The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue.	3-4 weeks after specimen processing

Trial Locations

Locations (1)

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States