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| Name | Class |
|---|---|
| Sequenom Laboratories | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | During initial presentation for treatment |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rita W Driggers, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15210050 | Background | Nagaishi M, Yamamoto T, Iinuma K, Shimomura K, Berend SA, Knops J. Chromosome abnormalities identified in 347 spontaneous abortions collected in Japan. J Obstet Gynaecol Res. 2004 Jun;30(3):237-41. doi: 10.1111/j.1447-0756.2004.00191.x. | |
| 11522246 | Background | Baena N, Guitart M, Ferreres JC, Gabau E, Corona M, Mellado F, Egozcue J, Caballin MR. Fetal and placenta chromosome constitution in 237 pregnancy losses. Ann Genet. 2001 Apr-Jun;44(2):83-8. doi: 10.1016/s0003-3995(01)01042-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis of cell free fetal DNA in 50 non-viable pregnancies.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age of participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | percentage of participants | During initial presentation for treatment |
|
|
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Serious and/or other [non-serious] adverse events were not collected/assessed as part of this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecily A. Clark-Ganheart | Medstar Washington Hospital Center | 202-877-3067 | ganheartmd@gmail.com |
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| ID | Term |
|---|---|
| D050497 | Stillbirth |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D005313 | Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Blood collection will consist of two ten milliliters samples of whole blood in the cffDNA STRECK tube. Plasma will be retained for analysis of circulating cell free fetal DNA.
| 22467168 | Background | Reddy UM, Page GP, Saade GR. The role of DNA microarrays in the evaluation of fetal death. Prenat Diagn. 2012 Apr;32(4):371-5. doi: 10.1002/pd.3825. |
| Background | American Congress of Obstetricians and Gynecologists, Management of Stillbirth. ACOG Practice Bulletin, 2009. 102 |
| 22005709 | Background | Palomaki GE, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Deciu C, Grody WW, Nelson SF, Canick JA. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study. Genet Med. 2011 Nov;13(11):913-20. doi: 10.1097/GIM.0b013e3182368a0e. |
| 8885928 | Background | Kyle PM, Sepulveda W, Blunt S, Davies G, Cox PM, Fisk NM. High failure rate of postmortem karyotyping after termination for fetal abnormality. Obstet Gynecol. 1996 Nov;88(5):859-62. doi: 10.1016/0029-7844(96)00311-0. |
| 19294965 | Background | MacDorman MF, Kirmeyer S. Fetal and perinatal mortality, United States, 2005. Natl Vital Stat Rep. 2009 Jan 28;57(8):1-19. |
| 26000503 | Derived | Clark-Ganheart CA, Fries MH, Leifheit KM, Jensen TJ, Moreno-Ruiz NL, Ye PP, Jennings JM, Driggers RW. Use of cell-free DNA in the investigation of intrauterine fetal demise and miscarriage. Obstet Gynecol. 2015 Jun;125(6):1321-1329. doi: 10.1097/AOG.0000000000000863. |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue. | Not Posted | 3-4 weeks after specimen processing | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
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| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |