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Placenta Accreta Spectrum Topographic Classification

Sponsor
Fundacion Clinica Valle del Lili (Other)
Overall Status
Recruiting
CT.gov ID
NCT05922397
Collaborator
(none)
326
Enrollment
1
Location
23.2
Anticipated Duration (Months)
14
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    326 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta Spectrum, a Multicentric Prospective Cohort Study
    Anticipated Study Start Date :
    Jun 25, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2025
    Anticipated Study Completion Date :
    Jun 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Days of postoperative hospitalization [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.]

      Number of days the patient was hospitalized from the day of surgery to the day of discharge

    2. Volume of intraoperative blood loss [During surgery]

      Surgical bleeding calculated in milliliters

    3. Bladder injury [Up to 42 days postpartum]

      Number of patients who had Bladder injuries

    4. Surgical reintervention [Up to 42 days postpartum]

      Number of patients who need surgical reoperation after index surgery

    5. Complications associated with vascular interventions [Up to 42 days postpartum]

      The patient presented thrombosis or other complication during post-surgery associated with vascular interventions.

    6. Maternal death [24 months]

      Does the patient die during this study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Pregnant woman over 18 years old.

    • Prenatal diagnosis by ultrasound or MRI of 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fundación Valle del Lili Cali Colombia

    Sponsors and Collaborators

    • Fundacion Clinica Valle del Lili

    Investigators

    • Principal Investigator: Albaro J Nieto-Calvache, MD, Fundacion Clinica Valle del Lili

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Fundacion Clinica Valle del Lili
    ClinicalTrials.gov Identifier:
    NCT05922397
    Other Study ID Numbers:
    • FVL-2125
    First Posted:
    Jun 28, 2023
    Last Update Posted:
    Jun 28, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundacion Clinica Valle del Lili
    Pregnancy outcomes
    Topographic classification
    Placenta acrreta
    Additional relevant MeSH terms:
    Placenta Accreta

    Study Results

    No Results Posted as of Jun 28, 2023