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MRI for the Diagnosis of Placenta Accreta Spectrum

Sponsor
Peking University Third Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04151979
Collaborator
(none)
200
Enrollment
1
Location
60
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Placenta Accreta Spectrum (PAS) is a disease associated with abnormal placental adhesion and invasion. In recent years, the incidence of PAS has increased significantly, which can cause massive postpartum hemorrhage, hysterectomy,and even maternal mortality. The research team of Peking university third hospital developed the ultrasound rating scale in china at first to conduct preliminary assessment of the PAS risk which can identify the severity of cases. In a basis of ultrasound, plan to explore the MRI for the the investigators diagnosis of PAS according to some specific PAS features, like the the uneven signal intensity , the myometrial discontinuity, and black band on T2 image, and finally established a MRI scoring system of PAS. MRI score system of PAS can reduce the subjective difference of the clinician's visual reading, and assist the clinician to assess the risk of sever PAS further, and conduct perioperative preparation to reduce the risk of maternal morbidity and mortality to achieve a better clinical outcome.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Placenta Accreta Spectrum (PAS) is a disease associated with abnormal placental adhesion and invasion. In recent years, the incidence of PAS has increased significantly, and the main risk is high hysterectomy rate,massive postpartum hemorrhage, and even maternal mortality in women at childbearing age. The research team of Peking university third hospital developed the ultrasound rating scale in china at first to conduct preliminary assessment of the PAS risk which can identify the severity of cases and guide the junior hospitals to transfer. Peking University third hospital is in the leading position in the preoperative diagnosis of PAS currently.

    Magnetic resonance imaging (MRI) has become a common method for preoperative evaluation for sever cases. MRI can provide a map of the placenta and PAS features, like the uterus enlarged significantly, the uneven signal intensity , the myometrial discontinuity, and black band on T2 image. It has a high diagnostic value. At present, only Lim and Ueno reported MRI scoring system for PAS. Due to the small sample size and the limitation of the research methods, a widely applicable rating scale has not been established. MRI score system of PAS can reduce the subjective difference of the clinician's visual reading, and assist the clinician to assess the risk of sever PAS further, and conduct perioperative preparation to reduce the risk of maternal morbidity and mortality and achieve a better clinical outcome.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    MRI for the Diagnosis of Placenta Accreta Spectrum
    Actual Study Start Date :
    Jan 1, 2015
    Anticipated Primary Completion Date :
    Dec 31, 2019
    Anticipated Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Rate of PAS diagnosed [one week after surgery]

      diagnose as PAS through clinical observation or specimen pathology after surgery

    Secondary Outcome Measures

    1. Blood loss volume(ml) [24 hours after surgery]

      The blood loss volume during the 24 hours after surgery

    2. Rate of hysterectomy [two weeks after surgery]

      Number of patients who were performed hysterectomy/Number of patients with PAS

    3. Rate of preterm labor [two weeks after surgery]

      The number of patients who delivered between 28 to 36+6 weeks/Number of patients with PAS

    4. Blood transfusion volume(ml) [two weeks after surgery]

      the volume of blood transfusion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients diagnosed as scarred uterus(with a history of cesarean section)

    2. "ultrasound score" of PASā‰„ 6 points who undergo MRI

    3. Terminate pregnancy or childbirth in Peking university third hospital. -

    Exclusion Criteria:

    1. Patients who didn't undergo MRI

    2. Patients who didn't deliver the baby in PUTH -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Third Hospital Peking Beijing China 100191

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    • Study Director: YangYu Zhao, MD, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT04151979
    Other Study ID Numbers:
    • PAS001
    First Posted:
    Nov 5, 2019
    Last Update Posted:
    Nov 5, 2019
    Last Verified:
    Oct 1, 2019
    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 Peking University Third Hospital
    placenta accreta spectrum
    MRI
    score scale
    diagnosis
    Additional relevant MeSH terms:
    Placenta Accreta

    Study Results

    No Results Posted as of Nov 5, 2019