Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler
1 other identifier
interventional
100
0 countries
N/A
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:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2018
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedStudy Start
First participant enrolled
May 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2018
CompletedMay 25, 2018
May 1, 2018
3 months
May 7, 2018
May 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
3 moths
Secondary Outcomes (1)
accuracy of ultrasound in detecting placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
3 months
Study Arms (2)
placenta previa
ACTIVE COMPARATORcases diagnosed as placenta previa diagnosed by ultrasound and doppler
placenta accreta
ACTIVE COMPARATORplacenta previa diagnosed as placenta accreta by ultrasound and doppler
Interventions
• 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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Maternal chronic medical disorder (diabetes mellitus or hypertension).
- Pregnancy induced disorders (pre-eclampsia or gestational diabetes).
- Associated fetal anomalies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hala Nabil, M.D
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
May 7, 2018
First Posted
May 21, 2018
Study Start
May 22, 2018
Primary Completion
August 22, 2018
Study Completion
August 22, 2018
Last Updated
May 25, 2018
Record last verified: 2018-05