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

• 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: Ain Shams University
• Information provided by (Responsible Party): Rehab Mohamed Abdelrahman, Ain Shams University

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Rehab Mohamed Abdelrahman, Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University, Ain Shams University
• ClinicalTrials.gov Identifier: NCT02712099
• Other Study ID Numbers: TUI 3D
• First Posted: March 18, 2016
• 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:

Placenta Accreta; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases