Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 :
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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 :
TUI 3D in Diagnosis of Placenta Accreta: Comparison with Gray-scale and Color Doppler Techniques
Not provided
Not provided
Not provided
Not provided
Not provided
study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital from August 2015 to march 2016.
Fifty pregnant women In whom the transabdominal scan revealed evidence of anterior placenta previa were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Women With Placenta Previa Who Had Easily Placenta Delivery | 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 : 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. Intraoperative:
|
| FG001 | Women With Placenta Previa Who Had Difficult Placenta Delivery | 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 : 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. Intraoperative:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Fifty pregnant women In whom the transabdominal scan revealed evidence of anterior placenta previa were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Women With Placenta Previa Who Had Easily Placenta Delivery | 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 : 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. Intraoperative:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 28 -36 weeks of gestation |
|
from 28 weeks to 36 weeks of gestation
Adverse Events were assessed during ultrasound examination
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women With Placenta Previa Who Had Easily Placenta Delivery | 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 : 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. Intraoperative:
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Rehab Mohamed Abdelrahman | Ain Shams University | +201004992772 | rehababdulrahman.rm@gmail.com |
Not provided
| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| BG001 | Women With Placenta Previa Who Had Difficult Placenta Delivery | 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 : 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. Intraoperative:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Women With Placenta Previa Who Had Difficult Placenta Delivery | 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 : 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. Intraoperative:
|
|
|
| Primary | 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 | Posted | Number | participants | 28 -36 weeks of gestation |
|
|
|
| Secondary | 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 | Posted | Number | participants | 28 -36 weeks of gestation |
|
|
|
| Secondary | 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 | Posted | Number | participants | 28 -36 weeks of gestation |
|
|
|
| Secondary | 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 | Posted | Number | participants | 28 -36 weeks of gestation |
|
|
|
| Secondary | 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 | Posted | Number | participants | 28 -36 weeks of gestation |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Women With Placenta Previa Who Had Difficult Placenta Delivery | 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 : 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. Intraoperative:
| 0 | 20 | 0 | 20 |
Not provided
Not provided
| D010922 | Placenta Diseases |