Placenta AccretaNCT07283042
Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta Spectrum
An observational study of Placenta Accreta, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Total Hysterectomy, Modified subtotal hysterectomy and One-Step Conservative Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- Patients who decline participation or withdraw consent
- Those with contraindications to the planned surgical procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Dana Levin-Lopez, MPH, 310-794-8893, dlevinlopez@mednet.ucla.edu
Yalda Afshar, MD, PhD
About this study
Official title: Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta
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.
Read the 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.
- Conditions
- Placenta Accreta
- Being tested
- Total Hysterectomy, Modified subtotal hysterectomy, One-Step Conservative Surgery
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total HysterectomyProcedure or surgery
Removal of entire uterus
Modified subtotal hysterectomyProcedure or surgery
When partial tissue integrity is preserved
One-Step Conservative SurgeryProcedure or surgery
Considered when significant healthy myometrium is preserved
| Study group | Role | What they receive |
|---|---|---|
| PAS | Patients with placental accreta undergoing planned surgical intervention for PAS Receives: Procedure: Total Hysterectomy; Procedure: Modified subtotal hysterectomy; Procedure: One-Step Conservative Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound assessment
Prenatal ultrasound assessment using the "Ultrasound Staging" protocol (6 views), with classification into one of the topographic categories
Measured: 0-30 days prior to planned surgery
Surgical Procedure and Classification
Intraoperative classification of the placental lesion using the topographic classification system
Measured: At time of surgery
Quantification of Blood Loss
Objective quantification of blood loss using suction devices, surgical sponges, and vaginal bleeding
Measured: 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
Measured: 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.
Measured: Up to 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yalda Afshar, MD, PhD, University of California, Los Angeles
- Investigators
- Yalda Afshar, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283042
- Sponsor's protocol ID
- 24-6300
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta
- ClinicalTrials.gov ID
- NCT07283042
- Acronym / sponsor ID
- 24-6300
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAS | – | Procedure: Total Hysterectomy, Procedure: Modified subtotal hysterectomy, Procedure: One-Step Conservative SurgeryPatients with placental accreta undergoing planned surgical intervention for PAS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who decline participation or withdraw consent
- Those with contraindications to the planned surgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total HysterectomyRemoval of entire uterus | Procedure or surgery | PAS |
| Modified subtotal hysterectomyWhen partial tissue integrity is preserved | Procedure or surgery | PAS |
| One-Step Conservative SurgeryConsidered when significant healthy myometrium is preserved | Procedure or surgery | PAS |
Primary outcome
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
Surgical Procedure and Classification
Time frame: At time of surgery
Intraoperative classification of the placental lesion using the topographic classification system
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yalda Afshar, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Levin-Lopez, MPH (310-794-8893, dlevinlopez@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound assessment (time frame: 0-30 days prior to planned surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.