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
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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.
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.
23 studies on the registry are indexed under Abruptio Placentae; 4 are open to participants now.
This study's enrollment of 1 is below the median of 184 across 12 observational studies indexed under Abruptio Placentae.
Browse Abruptio Placentae studies →University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 35 (95%) have results posted.
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Mother-infant dyads with suspected or confirmed diagnosis of placental abruption and healthy mother-infant dyads admitted for delivery.
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Exclusion Criteria:
Mother-infant dyads with suspected or confirmed diagnosis of placental abruption
Other: There is no other intervention, only clinical treatment.
Healthy mother-infant dyads admitted for delivery
Other: There 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.
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
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
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
Plan to share: No
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Ran from Jan 2019 to primary completion in Jan 2019, 0 months.
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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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