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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01916928
First Posted: August 6, 2013
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sequenom Laboratories
Information provided by (Responsible Party):
Medstar Health Research Institute
  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 Health 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 ]
    Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise


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 ]

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.

Enrollment: 50
Study Start Date: May 2013
Study Completion Date: December 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916928


Locations
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
Sequenom Laboratories
Investigators
Principal Investigator: Rita W Driggers, MD Medstar Washington Hospital Center
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT01916928     History of Changes
Other Study ID Numbers: 2012-414
First Submitted: August 2, 2013
First Posted: August 6, 2013
Results First Submitted: December 31, 2014
Results First Posted: February 2, 2015
Last Update Posted: March 13, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Abortion, Spontaneous
Fetal Death
Stillbirth
Pregnancy Complications
Death
Pathologic Processes