Plasma Concentration of Biological Markers in Placental Abruption

Terminated

• Conditions: Abruptio Placentae

• Registration Number: NCT03782168
• Lead Sponsor: University of Arkansas

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.

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 Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-20
• Study Start: 2019-01-31
• Primary Completion: 2019-01-31
• Study Completion: 2021-08-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-11-17
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.