Plasma Concentration of Biological Markers in Placenta Accreta Spectrum

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Plasma Concentration of Biological Markers in Placenta Spectrum

Conditions
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Placenta Accreta, Placenta Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placenta accreta spectrum<br>Mother-infant dyads with suspected or confirmed diagnosis of placenta accreta spectrum | |
| Phenotypically-matched controlled group<br>Mother-infant dyads admitted for delivery without placenta accreta spectrum | |

What is the study measuring?
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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 PAS and 10 phenotypically-matched controls. | 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. | Up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 6 hours |