Actively Recruiting

Age: 18Years - 55Years
FEMALE
Healthy Volunteers
ID05922397

Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta Spectrum A Multicentric Prospective Cohort Study

Led by Fundacion Clinica Valle del Lili · Updated on 2025-02-13

326

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a multicenter prospective study to evaluate clinical outcomes in pregnant patients diagnosed with placenta accreta spectrum (PAS). The study focuses on categorizing patients using a topographic classification system and assessing how well this classification is accepted by obstetrician-gynecologists at participating medical centers. The aim is to describe patient characteristics and correlate classification categories with clinical results. This observational study collects data from routine medical records of patients diagnosed prenatally or during surgery with PAS who undergo surgical intervention. The study includes multiple hospitals experienced in applying the PAS topographic classification. Data collection will cover outcomes until hospital discharge, with a planned enrollment period of two years starting from the first participant. Participants will have their postoperative hospital stay length, intraoperative blood loss, bladder injuries, surgical reinterventions, vascular complications, and maternal mortality monitored for up to 42 days postpartum, with maternal death tracked for up to 24 months. The study involves no experimental treatments, focusing on observing and recording clinical outcomes and surgeon acceptance of the classification system.

CONDITIONS

Brief Title

Placenta Accreta Spectrum Topographic Classification

Who Can Participate

Age: 18Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant woman over 18 years old
  • Prenatal diagnosis by ultrasound or MRI of Placenta Accreta Spectrum (PAS), regardless of the suspected degree of severity
  • Case requiring surgical management, either as scheduled or emergent procedure
  • Application of the topographic classification of placenta accreta spectrum during laparotomy
Not Eligible

You will not qualify if you...

  • None

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to the day of surgery

Participants undergo prenatal diagnosis by ultrasound or MRI to confirm placenta accreta spectrum.

1 or more visits as part of routine prenatal care

Surgery and Immediate Post-operative Care

Duration - From day of surgery until hospital discharge (up to 42 days postoperatively)

Participants have a surgical procedure where the topographic classification of placenta accreta spectrum is applied during laparotomy, followed by immediate post-operative care until hospital discharge.

Hospital stay with continuous monitoring

Post-operative Follow-up

Duration - Up to 42 days postpartum

Participants are monitored for complications such as bladder injury, surgical reintervention, and vascular complications up to 42 days postpartum.

Approximately 1 to 3 follow-up visits depending on recovery

Long-term Monitoring

Duration - Up to 24 months after surgery

Participants are followed for maternal survival outcomes for up to 24 months after surgery.

Periodic check-ins as part of routine care

Trial Site Locations

Total: 1 location

1

Fundación Valle del Lili

Cali, Colombia

Actively Recruiting

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Research Team

A

Albaro J Nieto-Calvache, MD

D

Daniela Sarria-Ortiz, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Frequently Asked Questions

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Published Research Related To This Trial

Placenta accreta spectrum: a hysterectomy can be prevented in almost 80% of cases using a resective-reconstructive technique.

José Miguel Palacios-Jaraquemada, Angel Fiorillo, Jorge Hamer...

https://pubmed.ncbi.nlm.nih.gov/31984808

Minimizing surgical blood loss at cesarean hysterectomy for placenta previa with evidence of placenta increta or placenta percreta: the state of play in 2020.

John C Kingdom, Sebastian R Hobson, Ally Murji...

https://pubmed.ncbi.nlm.nih.gov/32007492

Possible limitation to use the International Federation of Gynecology and Obstetrics classification of placenta accreta spectrum.

José M Palacios-Jaraquemada, Francesco D'Antonio

https://pubmed.ncbi.nlm.nih.gov/32565238

How to identify patients who require aortic vascular control in placenta accreta spectrum disorders?

Albaro José Nieto-Calvache, José Miguel Palacios-Jaraquemada, Rozi Aditya Aryananda...

https://pubmed.ncbi.nlm.nih.gov/34610485

Three-Dimensional Power Doppler Ultrasonography for Diagnosing Abnormally Invasive Placenta and Quantifying the Risk.

Sally L Collins, Gordon N Stevenson, Abdulla Al-Khan...

https://pubmed.ncbi.nlm.nih.gov/26214694

Prospective evaluation of impact of post-Cesarean section uterine scarring in perinatal diagnosis of placenta accreta spectrum disorder.

A M Hussein, R A Elbarmelgy, R M Elbarmelgy...

https://pubmed.ncbi.nlm.nih.gov/34225385