NCT01916928 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

American Congress of Obstetricians and Gynecologists, Management of Stillbirth
ACOG Practice Bulletin, 2009. 102
Baena N, Guitart M, Ferreres JC, Gabau E, Corona M, Mellado F, Egozcue J, Caballín MR
Fetal and placenta chromosome constitution in 237 pregnancy losses. Ann Genet. 2001 Apr-Jun;44(2):83-8.
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.
MacDorman MF, Kirmeyer S
Fetal and perinatal mortality, United States, 2005. Natl Vital Stat Rep. 2009 Jan 28;57(8):1-19.
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.
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.
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.

The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage

Clinical trial NCT01916928 - References