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Plasma Concentration of Biological Markers in Placental Abruption

Sponsor
University of Arkansas (Other)
Overall Status
Terminated
CT.gov ID
NCT03782168
Collaborator
(none)
1
Enrollment
1
Location
30
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be a prospective study conducted on women with a suspected/confirmed diagnosis of placental abruption. Maternal blood samples will be taken at various points during the peripartum period. A healthy group of women admitted for delivery will act as a matched control and will have their blood sampled at similar time points. The primary outcome variables will include the total number of micro-particles, the number of micro-particles from each cell line (platelet, placental, endothelial etc.), and protein markers (specifically; placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFLT-1), vascular endothelial growth factor (VEGF), soluble endoglin (sEng)). Secondary outcomes if will examine the correlation between placental micro-particles, biomarkers, and extent of placental abruption.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins will be analyzed to further increase our understanding of the pathological mechanisms involved in PA. The knowledge gained from this study has the potential to develop a diagnostic test for PA with the ability to improve outcomes for mother and baby through earlier diagnosis and targeted therapy.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Plasma Concentration of Biological Markers in Placental Abruption
    Actual Study Start Date :
    Jan 31, 2019
    Actual Primary Completion Date :
    Jan 31, 2019
    Actual Study Completion Date :
    Aug 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Placental Abruption

    Mother-infant dyads with suspected or confirmed diagnosis of placental abruption
    Phenotypically-matched controlled group

    Healthy mother-infant dyads admitted for delivery

    Outcome Measures

    Primary Outcome Measures

    1. Determine the level of placental-derived MPs (Microparticles/mL) [Up to 75 minutes]

      Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PA compared to 10 matched control subjects.

    2. Identify biomarkers (picogram/mL) specifically, placental growth factor (PlGF), vascular endothelial growth factor (VEGF), soluble fms-like tyrosine kinase-1 (sFLT-1), and soluble endoglin (sEng) [Up to 75 minutes]

      Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PA compared to 10 matched control subjects.

    Secondary Outcome Measures

    1. Examine the correlation between maternal serum total placental MPs and biomarkers to clinical symptomology and the severity of placental abruption after delivery. [Up to 75 minutes]

      In order to evaluate the secondary outcome, the correlation between maternal serum total placental MPs, biomarkers to clinical symptomology, and the severity of placental abruption after delivery will be examined.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18 - to 45-years old, inclusive

    • Suspected or confirmed PA or phenotypically matched controls

    • All modes of delivery

    • Gestational age greater than 28 weeks

    • Singleton pregnancy

    Exclusion Criteria:

    • Intrauterine fetal demise,

    • Severe fetal anomalies (infant not expected to survive)

    • Inability to communicate in English

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205

    Sponsors and Collaborators

    • University of Arkansas

    Investigators

    • Principal Investigator: Nadir Shawrawi, MD, University of Arkansas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Arkansas
    ClinicalTrials.gov Identifier:
    NCT03782168
    Other Study ID Numbers:
    • 228485
    First Posted:
    Dec 20, 2018
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Abruptio Placentae

    Study Results

    No Results Posted as of Nov 30, 2021