Plasma Concentration of Biological Markers in Placental Abruption

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.

Study Overview

• Status: Terminated
• Conditions: Abruptio Placentae

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Placental Abruption; Mother-infant dyads with suspected or confirmed diagnosis of placental abruption
Phenotypically-matched controlled group; Healthy mother-infant dyads admitted for delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abruptio Placentae
• Other Study ID Numbers: 228485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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