Detection of Urinary Bladder Wall Involvement in Abnormally Invasive Placenta (AIP) by 3D Ultrasonography

NCT05813743 | Completed DMC

• 1 other identifier: Abnormally invasive placenta
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

In the last three decades , the raise in cesarean delivery rates has led to a massive increase in the incidence of the abnormally invasive placenta .Complete separation of the abnormally invasive placenta is very difficult and usually fails and this may leads to life threatening hemorrhage and other morbidities e.g injury of the urinary tract. Antenatal diagnosis of the extent of the myometrial involvement may help in the anticipation and the planning of management eg: to proceed a conservative management or cesarean hysterectomy in case of extensive myometrial involvement . Three dimensional (3D) power Doppler ultrasound now represents a turning point for diagnosis the abnormal placentation .

Conditions

Placenta Accreta

Keywords

Abnormally invasive placenta; 3D ultrasound

Outcome Measures

Primary Outcomes (1)

• Accuracy of 3 dimensional ultrasound in detection of urinary bladder invasion in patients with abnormally invasive placenta

  The sensitivity and specificity of three dimensional ultrasound in the diagnosis of bladder wall invasion in patients with abnormally invasive placenta

  6 months

Study Arms (1)

Pregnant in 3rd trimester with abnormally invasive placenta

OTHER

Diagnostic Test: 3 dimensional ultrasound

Interventions

3 dimensional ultrasound DIAGNOSTIC_TEST

Detect the accuracy of 3D ultrasonography in prenatal detection of bladder wall involvement in abnormally invasive placenta (AIP) at 3rd trimester of pregnancy .

Pregnant in 3rd trimester with abnormally invasive placenta

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancies
• Previous cesarean deliveries
• Gestational age (GA)\> or= 28 weeks
• Low lying placenta previa totally or partially covering the internal os with lateral +/- anterior wall extension diagnosed as placenta accreta spectrum (PAS) disorders by 3D ultrasound

You may not qualify if:

• Patient's refusal to participate
• Multifetal pregnancies
• Gestational age\< 28 weeks.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: November 1, 2022
• Primary Completion: July 15, 2023
• Study Completion: August 1, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

EG (1)