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

Miscarriage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916928
• Other study ID #: MedStarWHC-OB
• Status: Completed
• Phase: N/A
• First received: August 2, 2013
• Last updated: January 29, 2015
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Circulating Cell Free Fetal DNA
• Fetal Death
• Intrauterine Fetal Demise
• Miscarriage

Locations

Country	Name	City	State
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Research Institute	Sequenom Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

MacDorman MF, Kirmeyer S. Fetal and perinatal mortality, United States, 2005. Natl Vital Stat Rep. 2009 Jan 28;57(8):1-19. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	During initial presentation for treatment	No
Secondary	The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue.		3-4 weeks after specimen processing	No