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Plasma Concentration of Biological Markers in Placenta Accreta Spectrum

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University of Arkansas

Status

Terminated

Conditions

Placenta Accreta
Placenta Diseases

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

19 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

19 participants in 2 patient groups

Placenta accreta spectrum
Description:
Mother-infant dyads with suspected or confirmed diagnosis of placenta accreta spectrum
Phenotypically-matched controlled group
Description:
Mother-infant dyads admitted for delivery without placenta accreta spectrum

Trial contacts and locations

1

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Central trial contact

Nadir Sharawi, MD

Data sourced from clinicaltrials.gov

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