University of California, Los Angeles
Los Angeles, California, 90095, United States
Location status: Recruiting
Location contact
Dana Levin-Lopez, MPH
CONTACT
Yalda Afshar, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07283042
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.
Interested in participating?
Request Info18 year–55 year
Female
Observational
Los Angeles, California, 90095, United States
Location status: Recruiting
Dana Levin-Lopez, MPH
CONTACT
Yalda Afshar, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Removal of entire uterus
When partial tissue integrity is preserved
Considered when significant healthy myometrium is preserved
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
Time frame: At time of surgery
Intraoperative classification of the placental lesion using the topographic classification system
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
Time frame: Within 2 hours post surgery
Post-surgery gross pathological analysis of resected tissues to correlate with ultrasound and surgical findings
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.
Contact information is provided by the study sponsor or research team.
University of California, Los Angeles
Other
Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta
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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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