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

ConditionPlacenta Accreta
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who decline participation or withdraw consent

Those with contraindications to the planned surgical procedure

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Total Hysterectomy

    Procedure/Surgery

    Removal of entire uterus

  • Modified subtotal hysterectomy

    Procedure/Surgery

    When partial tissue integrity is preserved

  • One-Step Conservative Surgery

    Procedure/Surgery

    Considered when significant healthy myometrium is preserved

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: PAS3 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Source ClinicalTrials.gov
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