Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03530475
• Other study ID #: 5000
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: August 22, 2018

Study information

• Verified date: May 2018
• Source: Kasr El Aini Hospital
• Contact: Hala Nabil, M.D
• Phone: 02001002412549
• Email: fawzy.jana[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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