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Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta Spectrum

About

Brief Summary

This study evaluates the clinical implementation of intra-operative topographic classification system for PAS. In addition to a standard of care risk stratification prenatal ultrasound for patients with a risk of PAS, this study adds an additional intraoperative surgical staging protocol to validate the classification system, improve surgical approach, and significantly clinical outcomes of pregnant people with an a prior risk of PAS. The study will involve pregnant patients with PAS risk factor, include data collection spanning prenatal assessment, intraoperative classification, surgical technique implementation and postoperative analysis. The anticipated study duration is approximately 36-48 months.

Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Observational

Eligibility

Gender
Female
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
55 Years

Inclusion Criteria:

  • Pregnant people suspected of having PAS based on ultrasound findings or clinical risk factors
  • Patients undergoing planned surgical intervention for PAS, including a planned cesarean
  • Individuals who provide informed consent to participate in the study
  • Patients with at least one prenatal assessment before surgery
  • Expected age range: 18-55
  • Patient has agreed to conservative management approach as part of standard of care if feasible intraoperatively

Exclusion Criteria:

  • Patients who decline participation or withdraw consent
  • Those with contraindications to the planned surgical procedure
Study Stats
Protocol No.
24-6300
Category
Pregnancy
Contact
  • Guadalupe Martinez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT07283042
For detailed technical eligibility, visit ClinicalTrials.gov.