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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Medstar Research Institute
Sponsor:
Information provided by (Responsible Party):
Cecily A. Clark-Ganheart MD, Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01916928
First received: August 2, 2013
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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.


Condition
Circulating Cell Free Fetal DNA
Intrauterine Fetal Demise
Miscarriage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • The presence or absence of cell free fetal DNA in maternal blood in the setting of a failed pregnancy. [ Time Frame: During initial presentation for treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Miscarriage
Women with fetal death prior to 20 weeks gestation.
Intrauterine Fetal Demise
Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916928

Contacts
Contact: Rita W. Driggers, MD 202-877-7127 Rita.W.Driggers@medstar.net
Contact: Cecily A Clark-Ganheart, MD 2692092048 ganheartmd@gmail.com

Locations
United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Cecily A Clark-Ganheart, MD    202-801-2186    cecily.a.clark-ganheart@medstar.net   
Principal Investigator: Rita W Driggers, MD         
Sub-Investigator: Cecily A Clark-Ganheart, MD         
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Rita W Driggers, MD Medstar Washington Hospital Center
  More Information

Publications:
Responsible Party: Cecily A. Clark-Ganheart MD, Director of Maternal Fetal Medicine, Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01916928     History of Changes
Other Study ID Numbers: MedStarWHC-OB
Study First Received: August 2, 2013
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
Circulating cell free fetal DNA
Intrauterine fetal demise
Miscarriage

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications

ClinicalTrials.gov processed this record on July 28, 2014