Placenta Accreta Spectrum Topographic Classification

NCT ID: NCT05922397

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 326 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-21
• Study Completion Date: 2025-06-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Pregnant woman over 18 years old.
• Prenatal diagnosis by ultrasound or MRI of Placenta Accreta Spectrum (PAS), regardless of the suspected degree of severity of the disease.
• Case requiring surgical management, either as scheduled or emergent procedure.
• Application of the topographic classification of placenta accreta spectrum during laparotomy.

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacion Clinica Valle del Lili

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albaro J Nieto-Calvache, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Clinica Valle del Lili

Locations

Fundación Valle del Lili

Cali, , Colombia

Site Status: RECRUITING

Countries

Colombia

Central Contacts

Albaro J Nieto-Calvache, MD

Role: CONTACT

albaro.nieto@fvl.org.co

6023319090 ext. 4022

Daniela Sarria-Ortiz, MD

Role: CONTACT

daniela.sarria.or@fvl.org.co

6023319090 ext. 3836

Facility Contacts

Albaro J Nieto-Calvache, M.D.

Role: primary

albaro.nieto@fvl.org.co

6023319090 ext. 3025

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FVL-2125

Identifier Type: -

Identifier Source: org_study_id