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

MedStar Health

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01916928

2012-414

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Non-viable pregnancy

Description:

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.