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

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ClinicalTrials.gov Identifier: NCT02712099
Recruitment Status : Completed
First Posted : March 18, 2016
Results First Posted : April 6, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Rehab Mohamed Abdelrahman, Ain Shams University

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques
Study Start Date : August 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

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Responsible Party: Rehab Mohamed Abdelrahman, Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT02712099     History of Changes
Other Study ID Numbers: TUI 3D
First Posted: March 18, 2016    Key Record Dates
Results First Posted: April 6, 2017
Last Update Posted: May 15, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Additional relevant MeSH terms:
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Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases