An observational study in Circulating Cell Free Fetal DNA, Intrauterine Fetal Demise and Miscarriage, sponsored by Medstar Health Research Institute. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-13.
Sponsored by Medstar Health Research Institute · Observational
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.
320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.
This study's enrollment of 50 is below the median of 200 across 140 observational studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women presenting to Washington Hospital Center with fetal loss would be offered DNA sequencing of cell free fetal DNA from maternal blood in addition to the standard workup for fetal demise and miscarriage as deemed appropriate by the patient's care provider. Only women with sonographic evidence of products of conception in-utero will be offered enrollment.
Exclusion Criteria:
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.
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
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
| Milestone | Non-viable Pregnancy |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise
| percentage of participants | Non-viable Pregnancy |
|---|---|
| The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy. | 50 |
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-viable Pregnancy | — | — | — |
Analysis of cell free fetal DNA in 50 non-viable pregnancies.
| Age, Continuous(years) | Non-viable Pregnancy |
|---|---|
| Mean | 31.4 ± 6.1 |
| Sex: Female, Male(Participants) | Non-viable Pregnancy |
|---|---|
| Female | 50 |
| Male | 0 |
| Region of Enrollment(participants) | Non-viable Pregnancy |
|---|---|
| United States | 50 |
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Medstar Health Research Institute