An observational study in Placenta Accreta, sponsored by Fundacion Clinica Valle del Lili. Recruiting at 1 site in Colombia. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Fundacion Clinica Valle del Lili · Observational
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.
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.
Exclusion Criteria:
Days of postoperative hospitalization
Number of days the patient was hospitalized from the day of surgery to the day of discharge
Time frame: 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.
Volume of intraoperative blood loss
Surgical bleeding calculated in milliliters
Time frame: During surgery
Bladder injury
Number of patients who had Bladder injuries
Time frame: Up to 42 days postpartum
Surgical reintervention
Number of patients who need surgical reoperation after index surgery
Time frame: Up to 42 days postpartum
Complications associated with vascular interventions
The patient presented thrombosis or other complication during post-surgery associated with vascular interventions.
Time frame: Up to 42 days postpartum
Maternal death
Does the patient die during this study
Time frame: 24 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — We do not plan to share individual participant data, since we are not allowed to share information concerning the medical history of our patients or health workers
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Fundacion Clinica Valle del Lili