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difficulties with enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placenta accreta spectrum | Mother-infant dyads with suspected or confirmed diagnosis of placenta accreta spectrum |
| |
| Phenotypically-matched controlled group | Mother-infant dyads admitted for delivery without placenta accreta spectrum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There is no other intervention, only clinical treatment. | Other | There is no other intervention, only clinical treatment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Mother-infant dyads with suspected or confirmed diagnosis of PAS and healthy mother-infant dyads admitted for cesarean delivery
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| Name | Affiliation | Role |
|---|---|---|
| Nadir e Sharawi, MD | UAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| D010922 | Placenta Diseases |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Whole blood for serum biomarkers and placental micro-particles.