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TerminatedNCT03782168Updated Sep 3, 2024

Plasma Concentration of Biological Markers in Placental Abruption

An observational study in Abruptio Placentae, sponsored by University of Arkansas. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-09-03.

Sponsored by University of Arkansas · Observational

Why this study was terminated
IRB approval expired; failure to submit continuing review in time. Will re-open once IRB approval is reinstated.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Abruptio Placentae

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03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Mother-infant dyads with suspected or confirmed diagnosis of placental abruption and healthy mother-infant dyads admitted for delivery.

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

Exclusion Criteria:

  • Intrauterine fetal demise,
  • Severe fetal anomalies (infant not expected to survive)
  • Inability to communicate in English
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Placental Abruption

    Mother-infant dyads with suspected or confirmed diagnosis of placental abruption

    Other: There is no other intervention, only clinical treatment.

  • Phenotypically-matched controlled group

    Healthy mother-infant dyads admitted for delivery

    Other: There is no other intervention, only clinical treatment.

Interventions

  • OtherThere is no other intervention, only clinical treatment.

    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.

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What researchers measure

Primary outcomes

  1. Determine the level of placental-derived MPs (Microparticles/mL)

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

    Time frame: Up to 75 minutes

  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)

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

    Time frame: Up to 75 minutes

Secondary outcomes

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

    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.

    Time frame: Up to 75 minutes

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Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03782168
Lead sponsor
University of Arkansas
Responsible party
Sponsor
First posted
Dec 20, 2018
Start date
Jan 31, 2019
Primary completion
Jan 31, 2019
Completion
Aug 1, 2021
Last update
Sep 3, 2024

Study contacts

Nadir Shawrawi, MD
principal investigator · University of Arkansas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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