Clinical trial NCT05922397: Placenta Accreta Spectrum Topographic Classification
Official title: Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta Spectrum, a Multicentric Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Placenta Accreta
Keywords: Pregnancy outcomes
Topographic classification
Placenta accreta
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 326
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Pregnant patients with a diagnosis of placenta accreta spectrum who visits any of the participating medical centers.
* Obstetrician-gynecologists working in participating medical centers.

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.

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.

Primary outcomes:
measure: Days of postoperative hospitalization
timeFrame: From the day the surgery is performed until the day of discharge or the date of death from any cause, whichever occurs first, evaluated up to 42 days.
measure: Volume of intraoperative blood loss
timeFrame: During surgery
measure: Bladder injury
timeFrame: Up to 42 days postpartum
measure: Surgical reintervention
timeFrame: Up to 42 days postpartum
measure: Complications associated with vascular interventions
timeFrame: Up to 42 days postpartum
measure: Maternal death
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundación Valle del Lili
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Albaro J Nieto-Calvache, MD
role: PRINCIPAL_INVESTIGATOR
References:
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