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

February 1, 2017 updated by: Medstar Health Research Institute

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During initial presentation for treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3-4 weeks after specimen processing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

Sequenom Laboratories

Investigators

  • Principal Investigator: Rita W Driggers, MD, MedStar Washington Hospital Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Miscarriage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe