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

NCT07283042 | Recruiting

• 1 other identifier: 24-6300
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

PAS

Patients with placental accreta undergoing planned surgical intervention for PAS

Procedure: Total Hysterectomy; Procedure: Modified subtotal hysterectomy; Procedure: One-Step Conservative Surgery

Interventions

Total Hysterectomy PROCEDURE

Removal of entire uterus

PAS

Modified subtotal hysterectomy PROCEDURE

When partial tissue integrity is preserved

PAS

One-Step Conservative Surgery PROCEDURE

Considered when significant healthy myometrium is preserved

PAS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients who decline participation or withdraw consent
• Those with contraindications to the planned surgical procedure

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Maternal Blood, Cord Blood, Cord Biopsy, and Placental Biopsy will be collected

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Yalda Afshar, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Levin-Lopez, MPH

CONTACT

310-794-8893; dlevinlopez@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)