search
Back to results

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

Primary Purpose

Placenta Accreta

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3 dimensional ultrasound
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Placenta Accreta focused on measuring Abnormally invasive placenta, 3D ultrasound

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pregnant in 3rd trimester with abnormally invasive placenta

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 3, 2023
Last Updated
August 29, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05813743
Brief Title
Detection of Urinary Bladder Wall Involvement in Abnormally Invasive Placenta (AIP) by 3D Ultrasonography
Official Title
How Accurate is Three Dimensional Ultrasonography in Prenatal Detection of Urinary Bladder Wall Involvement in Abnormally Invasive Placenta at 3rd Trimester of Pregnancy ?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 .
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta
Keywords
Abnormally invasive placenta, 3D ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregnant in 3rd trimester with abnormally invasive placenta
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
3 dimensional ultrasound
Intervention Description
Detect the accuracy of 3D ultrasonography in prenatal detection of bladder wall involvement in abnormally invasive placenta (AIP) at 3rd trimester of pregnancy .
Primary Outcome Measure Information:
Title
Accuracy of 3 dimensional ultrasound in detection of urinary bladder invasion in patients with abnormally invasive placenta
Description
The sensitivity and specificity of three dimensional ultrasound in the diagnosis of bladder wall invasion in patients with abnormally invasive placenta
Time Frame
6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo University
City
Giza
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs