Trial Outcomes & Findings for TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques (NCT NCT02712099)

NCT ID: NCT02712099

Last Updated: 2017-05-15

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: 28 -36 weeks of gestation
• Results posted on: 2017-05-15

Participant Flow

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.

Participant milestones

Measure	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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. 30 Women with placenta previa who had easily placenta delivery	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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. * When not separated easily manual removal was done, with uterotonics, together with uterine massage. 20 Women with placenta previa who had difficult placenta delivery
Overall Study STARTED	30	20
Overall Study COMPLETED	30	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Women With Placenta Previa Who Had Easily Placenta Delivery n=30 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. 30 Women with placenta previa who had easily placenta delivery	Women With Placenta Previa Who Had Difficult Placenta Delivery n=20 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. * When not separated easily manual removal was done, with uterotonics, together with uterine massage. 20 Women with placenta previa who had difficult placenta delivery	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=20 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants	20 Participants n=20 Participants	50 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	0 Participants n=20 Participants	0 Participants n=50 Participants
Sex: Female, Male Female	30 Participants n=30 Participants	20 Participants n=20 Participants	50 Participants n=50 Participants
Sex: Female, Male Male	0 Participants n=30 Participants	0 Participants n=20 Participants	0 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	30 participants n=30 Participants	20 participants n=20 Participants	50 participants n=50 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Women With Placenta Previa Who Had Easily Placenta Delivery n=30 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. 30 Women with placenta previa who had easily placenta delivery	Women With Placenta Previa Who Had Difficult Placenta Delivery n=20 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. * When not separated easily manual removal was done, with uterotonics, together with uterine massage. 20 Women with placenta previa who had difficult placenta delivery
Loss of the Retro Placental Sonolucent Zone by 2D Grayscale Ultrasonography	12 participants	19 participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Women With Placenta Previa Who Had Easily Placenta Delivery n=30 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. 30 Women with placenta previa who had easily placenta delivery	Women With Placenta Previa Who Had Difficult Placenta Delivery n=20 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. * When not separated easily manual removal was done, with uterotonics, together with uterine massage. 20 Women with placenta previa who had difficult placenta delivery
Abnormal Placental Lacunae by 2D Grayscale Ultrasonography	19 participants	15 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Women With Placenta Previa Who Had Easily Placenta Delivery n=30 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. 30 Women with placenta previa who had easily placenta delivery	Women With Placenta Previa Who Had Difficult Placenta Delivery n=20 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. * When not separated easily manual removal was done, with uterotonics, together with uterine massage. 20 Women with placenta previa who had difficult placenta delivery
Crowded Vessels Over Peripheral Sub-placental Zone by Power Doppler Ultrasonography	8 participants	18 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Women With Placenta Previa Who Had Easily Placenta Delivery n=30 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. 30 Women with placenta previa who had easily placenta delivery	Women With Placenta Previa Who Had Difficult Placenta Delivery n=20 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. * When not separated easily manual removal was done, with uterotonics, together with uterine massage. 20 Women with placenta previa who had difficult placenta delivery
Abnormal Placental Lacunae by Power Doppler Ultrasonography	20 participants	13 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Women With Placenta Previa Who Had Easily Placenta Delivery n=30 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. 30 Women with placenta previa who had easily placenta delivery	Women With Placenta Previa Who Had Difficult Placenta Delivery n=20 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. * When not separated easily manual removal was done, with uterotonics, together with uterine massage. 20 Women with placenta previa who had difficult placenta delivery
Crowded Vessels Over Peripheral Sub-placental Zone by 3D Tomographic Ultrasound Imaging (TUI)	7 participants	18 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Women With Placenta Previa Who Had Easily Placenta Delivery n=30 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. 30 Women with placenta previa who had easily placenta delivery	Women With Placenta Previa Who Had Difficult Placenta Delivery n=20 Participants 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: * Delivery of the fetus through the placenta. * 15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers. * When not separated easily manual removal was done, with uterotonics, together with uterine massage. 20 Women with placenta previa who had difficult placenta delivery
Abnormal Placental Lacunae by 3D Tomographic Ultrasound Imaging (TUI)	19 participants	13 participants

Adverse Events

Women With Placenta Previa Who Had Easily Placenta Delivery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Women With Placenta Previa Who Had Difficult Placenta Delivery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Rehab Mohamed Abdelrahman

Ain Shams University

Phone: +201004992772

Email: rehababdulrahman.rm@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place