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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.

Detailed Summary:

• 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.

Current Primary Outcome:

• Loss of the Retro Placental Sonolucent Zone by 2D Grayscale Ultrasonography [ Time Frame: 28 -36 weeks of gestation ]
  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
• Abnormal Placental Lacunae by 2D Grayscale Ultrasonography [ Time Frame: 28 -36 weeks of gestation ]
  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

Original Primary Outcome: Intraoperative signs suggestive of placental invasion during caesarian section [ Time Frame: 5 minutes after fetus delivery during caesarian section ]

Current Secondary Outcome:

• Crowded Vessels Over Peripheral Sub-placental Zone by Power Doppler Ultrasonography [ Time Frame: 28 -36 weeks of gestation ]
  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
• Abnormal Placental Lacunae by Power Doppler Ultrasonography [ Time Frame: 28 -36 weeks of gestation ]
  Power Doppler ultrasonography criteria by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section
• Crowded Vessels Over Peripheral Sub-placental Zone by 3D Tomographic Ultrasound Imaging (TUI) [ Time Frame: 28 -36 weeks of gestation ]
  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
• Abnormal Placental Lacunae by 3D Tomographic Ultrasound Imaging (TUI) [ Time Frame: 28 -36 weeks of gestation ]
  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

Original Secondary Outcome:

• 2 D grayscale ultrasonography of placenta previa with its lower edge covering the scar of previous cesarean section [ Time Frame: 28 -36 weeks of gestation ]

  2 D grayscale ultrasonography criteria of placenta accreta :

  1. Loss of the retro placental sonolucent zone.
  2. Irregular retro placental sonolucent zone.
  3. Thinning or disruption of hyperechoic serosa -bladder interface.
  4. Presence of focal exophytic masses invading the urinary bladder.
  5. Abnormal placental lacunae.
• Power Doppler ultrasonography of placenta previa with its lower edge covering the scar of previous cesarean section [ Time Frame: 28 -36 weeks of gestation ]

  Power Doppler ultrasonography criteria

  1. Numerous coherent vessels involving the whole uterine serosa -bladder junction (basal view)
  2. Hypervascularity (lateral view)
  3. Inseparable cotyledons and intervillous circulations,chaotic branching, detour vessels (lateral view)
• 3D tomographic ultrasound imaging (TUI) of placenta previa with its lower edge covering the scar of previous cesarean section [ Time Frame: 28 -36 weeks of gestation ]
  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

Dates:
Date Received: March 9, 2016
Date Started: August 2015
Date Completion:
Last Updated: April 9, 2017
Last Verified: April 2017