Placenta Accreta
Conditions
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.
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.
Interventions
PROCEDUREModified subtotal hysterectomy
When partial tissue integrity is preserved
PROCEDURETotal Hysterectomy
Removal of entire uterus
PROCEDUREOne-Step Conservative Surgery
Considered when significant healthy myometrium is preserved
Sponsors
University of California, Los Angeles
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound assessment | 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 |
| Surgical Procedure and Classification | At time of surgery | Intraoperative classification of the placental lesion using the topographic classification system |
| Quantification of Blood Loss | Documented throughout surgery and at the completion of the procedure | Objective quantification of blood loss using suction devices, surgical sponges, and vaginal bleeding |
| Gross Pathological Analysis of Resected Tissues | Within 2 hours post surgery | Post-surgery gross pathological analysis of resected tissues to correlate with ultrasound and surgical findings |
| Adverse Events | 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. |
Countries
United States
Contacts
CONTACTDana Levin-Lopez, MPH
PRINCIPAL_INVESTIGATORYalda Afshar, MD, PhD
University of California, Los Angeles
Outcome results
None listed