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

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.

Study Overview

• Status: Completed
• Conditions: Placenta Accreta

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loss of the Retro Placental Sonolucent Zone by 2D Grayscale Ultrasonography	2D grayscale ultrasonography criteria of placenta accreta by Loss of the retro placental sonolucent zone in placenta previa with its lower edge covering the scar of previous cesarean section	28 -36 weeks of gestation
Abnormal Placental Lacunae by 2D Grayscale Ultrasonography	2D grayscale ultrasonography criteria of placenta accreta by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section	28 -36 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crowded Vessels Over Peripheral Sub-placental Zone by Power Doppler Ultrasonography	Power Doppler ultrasonography criteria of Crowded vessels over peripheral sub-placental zone of in placenta previa with its lower edge covering the scar of previous cesarean section	28 -36 weeks of gestation
Abnormal Placental Lacunae by Power Doppler Ultrasonography	Power Doppler ultrasonography criteria by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section	28 -36 weeks of gestation
Crowded Vessels Over Peripheral Sub-placental Zone by 3D Tomographic Ultrasound Imaging (TUI)	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
Abnormal Placental Lacunae by 3D Tomographic Ultrasound Imaging (TUI)	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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: April 9, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: TUI 3D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• 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.
• Patient consent should be taken first.