Plasma Concentration of Biological Markers in Placental Abruption

Abruptio Placentae Clinical Trial

Official title:

Plasma Concentration of Biological Markers in Placental Abruption

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03782168
• Other study ID #: 228485
• Status: Terminated
• Start date: January 31, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2021
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 1, 2021
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abruptio Placentae

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 75 minutes
Primary	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.	Up to 75 minutes
Secondary	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.	Up to 75 minutes