NIH, National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) NIH - National Institutes of Health National Cancer Institute DCTD - Division of Cancer Treatment and Diagnosis

The effects of heparin, aspirin, and maternal clinical factors on the rate of non-reportable cell-free DNA results: A retrospective cohort study.

Author(s): Nitsche JF, Lovell D, Stephens N, Conrad S, Bebeau K, Brost BC

Publication: Am J Obstet Gynecol MFM, 2022, Vol. , Page 100846

PubMed ID: 36572105 PubMed Review Paper? No

Purpose of Paper

The purpose of this paper was to retrospectively investigate whether the use of heparin or aspirin; maternal age, weight, and race; or pre-existing conditions are associated with non-reportable (<2.8%) cell-free DNA (cfDNA) results in pregnant women.

Conclusion of Paper

Non-reportable results occurred in 46 of the 743 women eligible for the study, with 42 of these cases non-reportable due to low fetal fraction cfDNA. There was a significant association between a non-reportable result and aspirin use, heparin use, and patient weight. While there was a significant association between non-reportable results and a diagnosis of chronic hypertension, pregestational diabetes, or autoimmune disease, the associations were not significant after a correction for multiple testing was applied.  After correcting for multiple testing, parity of 3 was associated with a reduced risk of a non-reportable result (OR=0.29, P<0.05), but the associations were not significant for a parity of 1, 2 or 4. Importantly, there was no association between non-reportable results and patient age, patient race, or gestational age at blood collection.

Studies

  1. Study Purpose

    The purpose of this study was to retrospectively investigate if use of heparin or aspirin; maternal age, weight, and race; or pre-existing conditions are associated with non-reportable cf DNA results in pregnant women. Panorama cell-free fetal DNA testing results from 1,117 pregnant women were considered. This assay requires collection of a blood sample in Streck BCT tubes and shipment at room temperature. Data from women carrying twins or vanishing twins as well as those with incomplete records were excluded from analysis, which left data from 743 women. Of the 743 women included, 76 were taking 81 mg aspirin alone, 17 were taking heparin alone, and 10 were taking both aspirin and heparin. A total of 22 patients had an autoimmune disease (15 connective tissue disorder, 3 psoriatic arthritis, and one each with lupus erthyramatosus, polymyositis, rheumatoid arthritis, and ankylosing spondylitis). A fetal fraction of cell-free DNA <2.8% was automatically considered to be non-reportable.

    Summary of Findings:

    Non-reportable results occurred in 46 of the 743 women (6.1%) eligible for the study. The fetal fraction was significantly lower in specimens that yielded non-reportable results than those with reportable results (3.1 ± 2.1 versus 107±5.0, P<0.001) and low fetal fraction was identified as the cause of non-reportable results in 42 of these specimens. Of the 46 patients with non-reportable results, 28 (61%) had repeat testing; and another non-reportable result was obtained in 12 cases, and a high risk for trisomy was reported in two cases. The unadjusted and adjusted odds ratio (OR) of non-reportable results showed a significant association with aspirin use (OR=4.70 and OR=2.85, respectively, P<0.05) or heparin use (OR=12.06 and OR=21.87, respectively, P<0.05) alone; but while the adjusted OR of a non-reportable result was higher for patients taking both heparin and aspirin (OR=21.87), the association was not significant. There was a significant association of non-reportable results with patient weight (adjusted and unadjusted OR=1.02, P<0.05), but not patient age. There was a significant association of non-reportable results with a diagnosis of chronic hypertension (OR=5.26, P<0.05), pregestational diabetes (OR=2.46, P<0.05), and autoimmune disease (OR=3.59, P<0.05), but the associations were not significant after correcting for multiple testing.  After correcting for multiple testing, parity of 3 was associated with a reduced risk of a non-reportable result (OR=0.29, P<0.05), but the associations were not significant for a parity of 1, 2 or 4. Importantly, there was no association between non-reportable results and patient race or gestational age at the time of blood collection.

    Biospecimens
    Preservative Types
    • Streck/BCT
    Diagnoses:
    • Pregnant
    • Lupus
    • Other diagnoses
    • Rheumatoid Arthritis
    Platform:
    AnalyteTechnology Platform
    DNA Next generation sequencing
    Pre-analytical Factors:
    ClassificationPre-analytical FactorValue(s)
    Preaquisition Patient age Nonspecified range of ages compared mean= 33±9 years
    Preaquisition Other drugs Aspirin
    Heparin
    Aspirin and heparin
    Preaquisition Diagnosis/ patient condition Chronic hypertension
    Pre-gestational diabetes
    Autoimmune disease
    Non-specified range of gestational ages compared
    Patient weight considered (range not specified)
    Preaquisition Patient race Native American
    Asian
    Hawaiian Native or Pacific Islander
    African American
    Caucasian
    Hispanic
    More than one race

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