Plasma Concentration of Biological Markers in Placenta Accreta Spectrum

University of Arkansas19 enrolled

Overview

The purpose of this exploratory study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with placenta accreta spectrum (PAS) at the time of cesarean delivery in women with suspected PAS compared to women without PAS. Our aim is to determine if women with PAS have a unique MP and protein signature at the time of delivery compared with women without PAS.

Maternal blood samples will be taken at various points during the intrapartum 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 The knowledge gained from this study has the potential to develop a diagnostic test for PAS with the ability to improve management and outcomes for mother and baby through earlier diagnosis.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Placenta Accreta Placenta Diseases

Interventions

There is no other intervention, only clinical treatment.OTHER

There is no other intervention, only clinical treatment

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 - to 45-years old, inclusive * Suspected or confirmed PAS or phenotypically matched controls * Delivery by cesarean section * Gestational age greater than 28 weeks * Singleton pregnancy Exclusion Criteria: * Intrauterine fetal demise, * Severe fetal anomalies (infant not expected to survive) * Emergent cesarean delivery

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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 PAS and 10 phenotypically-matched controls.

Time frame: Up to 6 hours

Identify biomarkers (picogram/mL)

Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.

Time frame: Up to 6 hours

Secondary Outcomes

Is there a correlation between maternal serum total placental MPs and biomarkers to the International Federation of Gynecology and Obstetrics (FIGO) classification for PAS at the time of cesarean delivery.

Examine the correlation between maternal serum total placental MPs and biomarkers to the FIGO classification

Time frame: Up to 6 hours

Data from ClinicalTrials.gov

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