TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques

Placenta Accreta Clinical Trial

Official title:

TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712099
• Other study ID #: TUI 3D
• Status: Completed
• Phase: N/A
• First received: March 9, 2016
• Last updated: March 14, 2016
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health, Drug Policy and Planning Center
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the potential of the 3 D TUI view in diagnosis of morbidly adherent placenta in comparison to 2D grayscale, color Doppler and intraoperative findings.

Description:

• This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.

• All patients will undergo the following :

1. History taking

2. Clinical examination.

3. For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. History of previous cesarean section or hysterotomy.

2. Placenta previa with its lower edge covering the scar of previous cesarean section

3. From 28 wks to Full term.

Exclusion Criteria:

1. Multiple pregnancies.

2. Medical disorder as diabetes mellitus, hypertension.

3. Obese patients. BMI > 30

4. Intrauterine growth retardation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Placenta Accreta

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative signs suggestive of placental invasion during caesarian section	Intraoperative signs suggestive of placental invasion during caesarian section will be looked for and suspected by: A) Difficulty in placental separation and removal. B) Uncontrolled bleeding after placental separation in a well-contracted uterus.; C) Thinning of the lower uterine segment.	5 minutes after fetus delivery during caesarian section	Yes
Secondary	2 D grayscale ultrasonography of placenta previa with its lower edge covering the scar of previous cesarean section	2 D grayscale ultrasonography criteria of placenta accreta : Loss of the retro placental sonolucent zone.; Irregular retro placental sonolucent zone.; Thinning or disruption of hyperechoic serosa -bladder interface.; Presence of focal exophytic masses invading the urinary bladder.; Abnormal placental lacunae.	28 -36 weeks of gestation	Yes
Secondary	Power Doppler ultrasonography of placenta previa with its lower edge covering the scar of previous cesarean section	Power Doppler ultrasonography criteria; Numerous coherent vessels involving the whole uterine serosa -bladder junction (basal view); Hypervascularity (lateral view); Inseparable cotyledons and intervillous circulations,chaotic branching, detour vessels (lateral view)	28 -36 weeks of gestation	Yes
Secondary	3D tomographic ultrasound imaging (TUI) of placenta previa with its lower edge covering the scar of previous cesarean section	the examiner can simultaneously display, on the monitor or on a hard copy, up to 24 preselected parallel cuts from a volume. The slices can be generated either along the initial or any other reconstructed plane of the region of interest (ROI) in intervals of 0.5 - to 5 mm segments. Slice thickness will be adjusted as necessary for each individual case. The most informative image among the multiple images will be displayed with the use of CrossXBeam, a postprocessing tool that allows one to enhance tissue and border differentiation, leading to sharper depiction of the tissue margins	28 -36 weeks of gestation	Yes