NCT01916928|CompletedResults
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Sponsor study identifier
observational
50
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
August 2, 2013
Actual (reported)August 6, 2013
Actual (reported)January 2014
Actual (reported)December 2014
Actual (reported)February 2, 2015
Actual (reported)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
The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue.
3-4 weeks after specimen processing
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.
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.
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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.
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.
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.
Rita W Driggers, MD
Medstar Health Research Institute
50 participants (actual enrollment reported by the registry).
First Submitted
August 2, 2013
First Posted
August 6, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion
Contact the study team to confirm eligibility.
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.
American Congress of Obstetricians and Gynecologists, Management of Stillbirth. ACOG Practice Bulletin, 2009. 102
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.
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.
MacDorman MF, Kirmeyer S. Fetal and perinatal mortality, United States, 2005. Natl Vital Stat Rep. 2009 Jan 28;57(8):1-19.
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.
Primary Completion
January 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
March 13, 2017
Results First Posted
February 2, 2015
Record last verified: 2017-02
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