N/A
N=50
The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage
Circulating Cell Free Fetal DNA · Intrauterine Fetal Demise · Miscarriage
Bottom Line
View on ClinicalTrials.gov: NCT01916928 ↗Enrolled (actual)
50
Serious AEs
—
Results posted
Feb 2015
Primary outcome: Primary: The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy. — 50 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Medstar Health Research Institute
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy. |
50 | — |
| SECONDARY The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue. |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01916928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.