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RecruitingNCT07283042Updated Jan 16, 2026

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

An observational study in Placenta Accreta, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by University of California, Los Angeles · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

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.
02

Conditions studied

  • Placenta Accreta

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03

In context

Placenta Accreta

150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.

This study's planned enrollment of 60 is below the median of 87 across 78 observational studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • Patients who decline participation or withdraw consent
  • Those with to the planned surgical procedure
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • PAS

    Patients with placental accreta undergoing planned surgical intervention for PAS

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

Interventions

  • ProcedureTotal Hysterectomy

    Removal of entire uterus

  • ProcedureModified subtotal hysterectomy

    When partial tissue integrity is preserved

  • ProcedureOne-Step Conservative Surgery

    Considered when significant healthy myometrium is preserved

06

What researchers measure

Primary outcomes

  1. Ultrasound assessment

    Prenatal ultrasound assessment using the "Ultrasound Staging" protocol (6 views), with classification into one of the topographic categories

    Time frame: 0-30 days prior to planned surgery

  2. Surgical Procedure and Classification

    Intraoperative classification of the placental lesion using the topographic classification system

    Time frame: At time of surgery

  3. Quantification of Blood Loss

    Objective quantification of blood loss using suction devices, surgical sponges, and vaginal bleeding

    Time frame: Documented throughout surgery and at the completion of the procedure

  4. Gross Pathological Analysis of Resected Tissues

    Post-surgery gross pathological analysis of resected tissues to correlate with ultrasound and surgical findings

    Time frame: Within 2 hours post surgery

  5. 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.

    Time frame: Up to 12 months post surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Dec 2027, 24 months after the start.

Of 34 observational studies under Placenta Accreta, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 24 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2025
First posted
Dec 15, 2025
StartActual
Dec 1, 2025
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2028
Last update
Jan 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07283042
Responsible party
Yalda Afshar, MD, PhD (Professor of Obstetrics and Gynecology, University of California, Los Angeles) — Principal investigator
First posted
Dec 15, 2025
Start date
Dec 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 16, 2026

Study contacts

Dana Levin-Lopez, MPH
Contact
dlevinlopez@mednet.ucla.edu
310-794-8893
Yalda Afshar, MD, PhD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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