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
About this trial
This is an interventional diagnostic trial for Placenta Accreta
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.
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
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
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Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler
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