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.

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Key information

Conditions

Circulating Cell Free Fetal DNA Abortion, Spontaneous Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Intrauterine Fetal Demise Miscarriage Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Stillbirth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

Sequenom Laboratories

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Aug 6, 2013
Registry last updated: Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed