NCT05922397

Placenta Accreta Spectrum Topographic Classification

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 326 (estimated)
• Sponsor: Fundacion Clinica Valle del Lili · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study is a prospective multicenter study consisting of a cohort of patients with prenatal or intraoperative diagnosis of PAS, evaluating the clinical outcomes of the group of patients found in each category of the topographic classification. In addition, an approach to evaluate the acceptability of this classification among the obstetrician-gynecologists of the participating medical centers will be included.

Detailed description

The aim of this study is to describe the demographic and clinical characteristics of patients with a diagnosis of placenta accreta spectrum, and to determine the correlation between the topographic classification and the clinical outcomes found in the study. Finally, to evaluated whether the proposed classification is accepted by the obstetrician-gynecologists of the participating centers that manage placenta accreta spectrum patients. It is an observational, multicentric study of a prospective cohort, in which data will be obtained from the medical records and other documents in each participating center, which are considered to be of routine use in day-to-day clinical practice. The study of the outcomes proposed in this protocol will be limited to those recorded in the clinical records and will be taken into account until the participant is discharged from the hospital, during which a surgical intervention was performed due to the suspicion or diagnosis of PAS. It is projected that the period of patient enrollment will last 2 years, counting on from the first participant included. The study population is pregnant patients with a diagnosis of placenta accreta spectrum who visits any of the participating medical centers, and also obstetrician-gynecologists working in participating medical centers. The centers invited to participate are hospitals or clinics that already have knowledge in how to apply the surgical staging of PAS, and the topographic classification and have experience using it.

Conditions

• Placenta Accreta

Timeline

• Start date: 2023-05-21
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-06-28
• Last updated: 2025-02-13

Locations

1 site across 1 country: Colombia