Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler

Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler in Cases of Placenta Accreta

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:

Study Overview

• Status: Unknown
• Conditions: Placenta Accreta
• Intervention / Treatment: Diagnostic test: ultrasound and doppler

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hala Nabil, M.D; Phone Number: 02001002412549; Email: fawzy.jana@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: placenta previa; cases diagnosed as placenta previa diagnosed by ultrasound and doppler	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.
Active Comparator: placenta accreta; placenta previa diagnosed as placenta accreta by ultrasound and doppler	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Principal Investigator: Hala Nabil, M.D, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 22, 2018
• Primary Completion (Anticipated): August 22, 2018
• Study Completion (Anticipated): August 22, 2018

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 25, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: 5000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No