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

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

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 Overview

• Status: Recruiting
• Conditions: Placenta Accreta
• Intervention / Treatment: Procedure: Total Hysterectomy; Procedure: Modified subtotal hysterectomy; Procedure: One-Step Conservative Surgery

Detailed Description

This study is a prospective cohort study designed to assess the validity, feasibility, and clinical utility of a topographic classification system for placenta accreta spectrum (PAS), with a primary focus on its application in the actual execution of surgery. This study is investigating a clinical decision flowchart used for intraoperative staging and classification of placenta accreta spectrum (PAS) or similar uterine surgical scenarios. It integrates topographic classification, surgical decision-making, and treatment strategy selection.

The classification system will directly guide and be integrated into real-time surgical planning and management-from cesarean hysterectomy to one-step conservative surgery-based on prenatal ultrasound staging and intraoperative findings.

• Standardizing prenatal ultrasound staging for PAS.
• Implementing a structured protocol for intraoperative classification and surgical execution according to ultrasound.
• Collecting and correlating surgical and pathological findings, including intraoperative photos, videos, and gross and histological analysis.
• Utilizing an objective method to quantify intraoperative blood loss.
• Comparing preoperative ultrasound findings with intraoperative and postoperative data to validate the classification system.
• Managing participant dropouts and protocol deviations to ensure data integrity and minimize bias.
• Applying appropriate statistical adjustments for multiple group comparisons to reduce the risk of type I error. Methods such as Bonferroni correction or false discovery rate adjustments will be utilized where applicable.
• Incorporating serial blood draws for plasma and whole blood analysis to identify potential biomarkers associated with PAS severity, surgical complexity, and clinical outcomes. This will be optional and stored in the biorepository.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Dana Levin-Lopez, MPH; Phone Number: 310-794-8893; Email: dlevinlopez@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
      • Contact: Dana Levin-Lopez, MPH; Phone Number: 310-794-8893; Email: dlevinlopez@mednet.ucla.edu
      • Principal Investigator: Yalda Afshar, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will be comprised of pregnant people suspected of having PAS. PAS is a major obstetric complication associated with significant maternal morbidity and mortality that is increasing in prevalence due to the rising rate of cesarean births, which are the biggest clinical risk factor

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PAS; Patients with placental accreta undergoing planned surgical intervention for PAS	Procedure: Total Hysterectomy; Removal of entire uterus; Procedure: Modified subtotal hysterectomy; When partial tissue integrity is preserved; Procedure: One-Step Conservative Surgery; Considered when significant healthy myometrium is preserved

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound assessment	Prenatal ultrasound assessment using the "Ultrasound Staging" protocol (6 views), with classification into one of the topographic categories	0-30 days prior to planned surgery
Surgical Procedure and Classification	Intraoperative classification of the placental lesion using the topographic classification system	At time of surgery
Quantification of Blood Loss	Objective quantification of blood loss using suction devices, surgical sponges, and vaginal bleeding	Documented throughout surgery and at the completion of the procedure
Gross Pathological Analysis of Resected Tissues	Post-surgery gross pathological analysis of resected tissues to correlate with ultrasound and surgical findings	Within 2 hours post surgery
Adverse Events	Presence of any of the following during follow up will be measured in a binary fashion (Yes/No): re-admissions, re-operations, infection/sepsis, wound seroma.	Up to 12 months post surgery

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Yalda Afshar, MD, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Estimated): December 15, 2025

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: 24-6300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No