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

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 .

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, 12613, Egypt

About this study

Our study aimes to detect the accuracy of 3D ultrasonography in prenatal detection of urinary bladder wall involvement in abnormally invasive placenta (AIP) at 3rd trimester of pregnancy .

All patients will be subjected to the following:

1-Written informed consent after explaining the aim of the study, procedure and possible hazards.

2-History taking includes full obstetric history, medical and surgical history. 3-Relevant physical examination.

In all cases, detailed transabdominal and transvaginal examinations of the placenta, uterus and pelvis will be performed within 48 hours before surgery will be done by ultrasound equipment type (GE Voluson E10).
During the ultrasound examination the following criteria will be studied:

Placental localization and determining placental extension : The placenta will be recorded as low lying when the edge is 0.5-2 cm from the internal os of the uterine cervix. When the placenta is <0.5 cm from the internal os or completely covering it, it will be defined as placenta previa (marginal or complete respectively).
The criteria suggested by the European working group on Abnormally invasive placenta (EW-AIP)25 which include:

Loss of clear zone in the myometrium under the placental bed.
Myometrial thinning to less than 1 mm.
Intra-placental lacunae which are large and irregular.
Bladder wall interruption or loss.
Placental bulge or focal exophytic mass extending beyond the serosa of the uterus.
Color Doppler images:

-- Uterovesical hypervascularity between placenta and posterior wall of the bladder.

Bridging vessels across the myometrium and beyond uterine serosa.
Sub-placental hypervascularity.
Lacunae feeder vessels with high velocity.
The results of 3D ultrasound will be compared with the results of histopathological examination of the retrieved specimens in cases of cesarean hysterectomy or partial myometrial resection or with the operative finding of spontaneous and complete placental separation at laparotomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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 .

Primary outcomes

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

Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

How Accurate is Three Dimensional Ultrasonography in Prenatal Detection of Urinary Bladder Wall Involvement in Abnormally Invasive Placenta at 3rd Trimester of Pregnancy ?

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Apr 14, 2023
Registry last updated: Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed