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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAS | Patients with placental accreta undergoing planned surgical intervention for PAS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hysterectomy | Procedure | Removal of entire uterus |
| |
| Modified subtotal hysterectomy |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dana Levin-Lopez, MPH | Contact | 310-794-8893 | dlevinlopez@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yalda Afshar, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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Maternal Blood, Cord Blood, Cord Biopsy, and Placental Biopsy will be collected
| Procedure |
When partial tissue integrity is preserved |
|
| One-Step Conservative Surgery | Procedure | Considered when significant healthy myometrium is preserved |
|
| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010922 | Placenta Diseases |
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