Placenta AccretaNCT02712099
TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques
An observational study of Placenta Accreta, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- History of previous cesarean section or hysterotomy.
- Placenta previa with its lower edge covering the scar of previous cesarean section
- From 28 wks to Full term.
Who cannot join
- Multiple pregnancies.
- Medical disorder as diabetes mellitus, hypertension.
- Obese patients. BMI > 30
- Intrauterine growth retardation.
About this study
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.
Read the 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 :
- History taking
- Clinical examination.
- 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.
- Conditions
- Placenta Accreta
- Medical subject headings
- Placenta Accreta
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 28 -36 weeks of gestation
Secondary outcomes (4)
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
Measured: 28 -36 weeks of gestation
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
Measured: 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
Measured: 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
Measured: 28 -36 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Abdelrahman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712099
- Sponsor's protocol ID
- TUI 3D
- Status last verified
- Apr 2017
- First submitted
- 9 Mar 2016
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques
- ClinicalTrials.gov ID
- NCT02712099
- Acronym / sponsor ID
- TUI 3D
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 6 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 :
- History taking
- Clinical examination.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- History of previous cesarean section or hysterotomy.
- Placenta previa with its lower edge covering the scar of previous cesarean section
- From 28 wks to Full term.
Key exclusion criteria (4 listed)
- Multiple pregnancies.
- Medical disorder as diabetes mellitus, hypertension.
- Obese patients. BMI > 30
- Intrauterine growth retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
4 secondary outcomes
Crowded Vessels Over Peripheral Sub-placental Zone by Power Doppler Ultrasonography
Time frame: 28 -36 weeks of gestation
Abnormal Placental Lacunae by Power Doppler Ultrasonography
Time frame: 28 -36 weeks of gestation
Crowded Vessels Over Peripheral Sub-placental Zone by 3D Tomographic Ultrasound Imaging (TUI)
Time frame: 28 -36 weeks of gestation
Abnormal Placental Lacunae by 3D Tomographic Ultrasound Imaging (TUI)
Time frame: 28 -36 weeks of gestation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of the Retro Placental Sonolucent Zone by 2D Grayscale Ultrasonography (time frame: 28 -36 weeks of gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.