Circulating Cell Free Fetal DNA, Intrauterine Fetal Demise, Miscarriage
Conditions
Keywords
Circulating cell free fetal DNA, Intrauterine fetal demise, Miscarriage
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.
Interventions
None listed
Sponsors
Sequenom Laboratories
Medstar Health Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue. | 3-4 weeks after specimen processing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-viable Pregnancy 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. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Non-viable Pregnancy |
|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 6.1 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy.
Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise
Time frame: During initial presentation for treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-viable Pregnancy | The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy. | 50 percentage of participants |
Secondary
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