Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler
Overview
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:
Full Title of Study: “Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler in Cases of Placenta Accreta”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: August 22, 2018
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
Interventions
- Diagnostic Test: ultrasound and doppler
- • 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.
Arms, Groups and Cohorts
- Active Comparator: placenta previa
- cases diagnosed as placenta previa diagnosed by ultrasound and doppler
- Active Comparator: placenta accreta
- placenta previa diagnosed as placenta accreta by ultrasound and doppler
Clinical Trial Outcome Measures
Primary Measures
- accuracy of ultrasound and doppler in detecting placenta accreta
- Time Frame: 3 moths
- accuracy of uterine artery doppler in diagnosing placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
Secondary Measures
- accuracy of ultrasound in detecting placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
- Time Frame: 3 months
- 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
Participating in This Clinical Trial
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.
Gender Eligibility: Female
Minimum Age: 20 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Kasr El Aini Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: hala nabil, principle investigator – Cairo University
- Overall Official(s)
- Hala Nabil, M.D, Principal Investigator, Cairo University
- Overall Contact(s)
- Hala Nabil, M.D, 02001002412549, fawzy.jana@yahoo.com
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