search
Back to results

Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler

Primary Purpose

Placenta Accreta

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound and doppler
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Placenta Accreta

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Criteria:Inclusion Criteria

  • Gestational age more than 28 weeks
  • Single living fetus.
  • One or more cesarean section or hysterotomy.
  • Placenta previa (all grades) with high possibility of morbidly adherent placenta accreta (all types).

Exclusion Criteria:

  • Maternal chronic medical disorder (diabetes mellitus or hypertension).
  • Pregnancy induced disorders (pre-eclampsia or gestational diabetes).
  • Associated fetal anomalies.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    placenta previa

    placenta accreta

    Arm Description

    cases diagnosed as placenta previa diagnosed by ultrasound and doppler

    placenta previa diagnosed as placenta accreta by ultrasound and doppler

    Outcomes

    Primary Outcome Measures

    accuracy of ultrasound and doppler in detecting placenta accreta
    accuracy of uterine artery doppler in diagnosing placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy

    Secondary Outcome Measures

    accuracy of ultrasound in detecting placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
    Loss of normal hypoechoic retroplacental zone Multiple vascular lacunae (irregular vascular spaces) within placenta Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface, or crossing uterine serosa1 Retroplacental myometrial thickness of 1 mm Bladder wall interruption Presence of placental bulge Utero-vesical hypervascularity 3.Intraoperative complications

    Full Information

    First Posted
    May 7, 2018
    Last Updated
    May 23, 2018
    Sponsor
    Kasr El Aini Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03530475
    Brief Title
    Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler
    Official Title
    Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler in Cases of Placenta Accreta
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 22, 2018 (Anticipated)
    Primary Completion Date
    August 22, 2018 (Anticipated)
    Study Completion Date
    August 22, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kasr El Aini Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed). All of those patients are presenting during the period of may 2018 to july 2018 to Kasr-Al Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester. All of them will be assorted according to certain inclusion and exclusion criterions as follow:
    Detailed Description
    This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed). Those patients are attending to Kasr-Al Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester. Ultrasound and doppler will be done to all patients to diagnose placenta accreta . The diagnosis will be confirmed by intraoperative assessments and histopathological examination of the uterus after cesarean hysterectomy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Placenta Accreta

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    placenta previa
    Arm Type
    Active Comparator
    Arm Description
    cases diagnosed as placenta previa diagnosed by ultrasound and doppler
    Arm Title
    placenta accreta
    Arm Type
    Active Comparator
    Arm Description
    placenta previa diagnosed as placenta accreta by ultrasound and doppler
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    ultrasound and doppler
    Intervention Description
    • Ultrasound examination (2D gray scale and color doppler ) 1. Confirming the presence of placenta previa 2,To assess the possibility of concomitant placenta accreta (Sonographic findings that have been associated with placenta accreta (1) Loss of normal hypoechoic retroplacental zone (2) Multiple vascular lacunae (irregular vascular spaces) within placenta, (3) Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface, or crossing uterine serosa1 (4) Retroplacental myometrial thickness of 1 mm (5) Bladder wall interruption (6) Presence of placental bulge (7) Utero-vesical hypervascularity (8) presence of lacunae feeder vessels. 3. Assessment of uterine artery Doppler in different cases of placenta previa. . Documentation of the operative findings during cesarean section and/or cesarean hysterectomy procedures. Histopathological examination of the hysterectomy specimens to assess the degree of myometrial invasion.
    Primary Outcome Measure Information:
    Title
    accuracy of ultrasound and doppler in detecting placenta accreta
    Description
    accuracy of uterine artery doppler in diagnosing placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
    Time Frame
    3 moths
    Secondary Outcome Measure Information:
    Title
    accuracy of ultrasound in detecting placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
    Description
    Loss of normal hypoechoic retroplacental zone Multiple vascular lacunae (irregular vascular spaces) within placenta Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface, or crossing uterine serosa1 Retroplacental myometrial thickness of 1 mm Bladder wall interruption Presence of placental bulge Utero-vesical hypervascularity 3.Intraoperative complications
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Criteria:Inclusion Criteria Gestational age more than 28 weeks Single living fetus. One or more cesarean section or hysterotomy. Placenta previa (all grades) with high possibility of morbidly adherent placenta accreta (all types). Exclusion Criteria: Maternal chronic medical disorder (diabetes mellitus or hypertension). Pregnancy induced disorders (pre-eclampsia or gestational diabetes). Associated fetal anomalies.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hala Nabil, M.D
    Phone
    02001002412549
    Email
    fawzy.jana@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hala Nabil, M.D
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler

    We'll reach out to this number within 24 hrs