Classification of Placenta Accreta Spectrum and its Outcomes
Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta Spectrum, a Multicentric Prospective Cohort Study
This study is testing how a new way to classify placenta accreta spectrum can help doctors understand the outcomes for pregnant patients who need surgery for this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 326 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Fundacion Clinica Valle del Lili Academic / other |
| Locations | 1 site (Cali) |
| Trial ID | NCT05922397 on ClinicalTrials.gov |
What this trial studies
This observational multicenter study aims to evaluate the clinical outcomes of pregnant patients diagnosed with placenta accreta spectrum (PAS) based on a topographic classification. It will collect demographic and clinical data from medical records of patients who undergo surgical management for PAS. Additionally, the study will assess the acceptability of this classification among obstetrician-gynecologists at participating centers. The enrollment period is projected to last for two years, focusing on patients requiring surgical intervention due to PAS.
Who should consider this trial
Good fit: Ideal candidates include pregnant women over 18 years old with a prenatal diagnosis of placenta accreta spectrum requiring surgical management.
Not a fit: Patients without a diagnosis of placenta accreta spectrum or those not requiring surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and outcomes of patients with placenta accreta spectrum.
How similar studies have performed: While this approach is based on existing classifications, the specific application and evaluation of this topographic classification in a multicenter setting is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cali
- Fundación Valle del Lili — Cali, Colombia (Recruiting)
Study contacts
- Principal investigator: Albaro J Nieto-Calvache, MD — Fundacion Clinica Valle del Lili
- Study coordinator: Albaro J Nieto-Calvache, MD
- Email: albaro.nieto@fvl.org.co
- Phone: 6023319090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.