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NCT Number: NCT07283042

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Dana Levin-Lopez, MPH

CONTACT

[email protected]

310-794-8893

Yalda Afshar, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Hysterectomy

Procedure

Removal of entire uterus

Modified subtotal hysterectomy

Procedure

When partial tissue integrity is preserved

One-Step Conservative Surgery

Procedure

Considered when significant healthy myometrium is preserved

Primary outcomes

  1. Ultrasound assessment

    Time frame: 0-30 days prior to planned surgery

    Prenatal ultrasound assessment using the "Ultrasound Staging" protocol (6 views), with classification into one of the topographic categories

  2. Surgical Procedure and Classification

    Time frame: At time of surgery

    Intraoperative classification of the placental lesion using the topographic classification system

  3. Quantification of Blood Loss

    Time frame: Documented throughout surgery and at the completion of the procedure

    Objective quantification of blood loss using suction devices, surgical sponges, and vaginal bleeding

  4. Gross Pathological Analysis of Resected Tissues

    Time frame: Within 2 hours post surgery

    Post-surgery gross pathological analysis of resected tissues to correlate with ultrasound and surgical findings

  5. Adverse Events

    Time frame: Up to 12 months post surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Levin-Lopez, MPH

CONTACT

[email protected]

310-794-8893

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 15, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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