Placenta AccretaNCT05813743
Detection of Urinary Bladder Wall Involvement in Abnormally Invasive Placenta (AIP) by 3D Ultrasonography
A study testing 3 dimensional ultrasound in people with Placenta Accreta, run by Cairo University at 1 site in Egypt.
Trial summary
In the last three decades , the raise in cesarean delivery rates has led to a massive increase in the incidence of the abnormally invasive placenta .Complete separation of the abnormally invasive placenta is very difficult and usually fails and this may leads to life threatening hemorrhage and other morbidities e.g… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- 3 dimensional ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Singleton pregnancies
- Previous cesarean deliveries
- Gestational age (GA)> or= 28 weeks
- Low lying placenta previa totally or partially covering the internal os with lateral +/- anterior wall extension diagnosed as placenta accreta spectrum (PAS) disorders by 3D ultrasound
Who cannot join
- Patient's refusal to participate
- Multifetal pregnancies
- Gestational age< 28 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Accurate is Three Dimensional Ultrasonography in Prenatal Detection of Urinary Bladder Wall Involvement in Abnormally Invasive Placenta at 3rd Trimester of Pregnancy ?
In the last three decades , the raise in cesarean delivery rates has led to a massive increase in the incidence of the abnormally invasive placenta .Complete separation of the abnormally invasive placenta is very difficult and usually fails and this may leads to life threatening hemorrhage and other morbidities e.g injury of the urinary tract.
Antenatal diagnosis of the extent of the myometrial involvement may help in the anticipation and the planning of management eg: to proceed a conservative management or cesarean hysterectomy in case of extensive myometrial involvement . Three dimensional (3D) power Doppler ultrasound now represents a turning point for diagnosis the abnormal placentation .
Read the detailed description
Our study aimes to detect the accuracy of 3D ultrasonography in prenatal detection of urinary bladder wall involvement in abnormally invasive placenta (AIP) at 3rd trimester of pregnancy .
All patients will be subjected to the following:
1-Written informed consent after explaining the aim of the study, procedure and possible hazards.
2-History taking includes full obstetric history, medical and surgical history. 3-Relevant physical examination.
- In all cases, detailed transabdominal and transvaginal examinations of the placenta, uterus and pelvis will be performed within 48 hours before surgery will be done by ultrasound equipment type (GE Voluson E10).
- During the ultrasound examination the following criteria will be studied:
- Placental localization and determining placental extension : The placenta will be recorded as low lying when the edge is 0.5-2 cm from the internal os of the uterine cervix. When the placenta is <0.5 cm from the internal os or completely covering it, it will be defined as placenta previa (marginal or complete respectively).
- The criteria suggested by the European working group on Abnormally invasive placenta (EW-AIP)25 which include:
- Loss of clear zone in the myometrium under the placental bed.
- Myometrial thinning to less than 1 mm.
- Intra-placental lacunae which are large and irregular.
- Bladder wall interruption or loss.
- Placental bulge or focal exophytic mass extending beyond the serosa of the uterus.
- Color Doppler images: -- Uterovesical hypervascularity between placenta and posterior wall of the bladder.
- Bridging vessels across the myometrium and beyond uterine serosa.
- Sub-placental hypervascularity.
- Lacunae feeder vessels with high velocity.
- The results of 3D ultrasound will be compared with the results of histopathological examination of the retrieved specimens in cases of cesarean hysterectomy or partial myometrial resection or with the operative finding of spontaneous and complete placental separation at laparotomy.
- Conditions
- Placenta Accreta
- Being tested
- 3 dimensional ultrasound
- Keywords
- Abnormally invasive placenta, 3D ultrasound
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 dimensional ultrasoundDiagnostic test
Detect the accuracy of 3D ultrasonography in prenatal detection of bladder wall involvement in abnormally invasive placenta (AIP) at 3rd trimester of pregnancy .
| Study group | Role | What they receive |
|---|---|---|
| Pregnant in 3rd trimester with abnormally invasive placenta | Other | Not described Receives: Diagnostic Test: 3 dimensional ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of 3 dimensional ultrasound in detection of urinary bladder invasion in patients with abnormally invasive placenta
The sensitivity and specificity of three dimensional ultrasound in the diagnosis of bladder wall invasion in patients with abnormally invasive placenta
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 Nov 2022
- Primary completion15 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mostafa Mohammed Refaay El shemy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813743
- Sponsor's protocol ID
- Abnormally invasive placenta
- Status last verified
- Aug 2023
- First submitted
- 3 Apr 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Accurate is Three Dimensional Ultrasonography in Prenatal Detection of Urinary Bladder Wall Involvement in Abnormally Invasive Placenta at 3rd Trimester of Pregnancy ?
- ClinicalTrials.gov ID
- NCT05813743
- Acronym / sponsor ID
- Abnormally invasive placenta
- Conditions
- Placenta Accreta
- Keywords
- Abnormally invasive placenta, 3D ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the last three decades , the raise in cesarean delivery rates has led to a massive increase in the incidence of the abnormally invasive placenta .Complete separation of the abnormally invasive placenta is very difficult and usually fails and this may leads to life threatening hemorrhage and other morbidities e.g injury of the urinary tract.
Antenatal diagnosis of the extent of the myometrial involvement may help in the anticipation and the planning of management eg: to proceed a conservative management or cesarean hysterectomy in case of extensive myometrial involvement . Three dimensional (3D) power Doppler ultrasound now represents a turning point for diagnosis the abnormal placentation .
Detailed description
Our study aimes to detect the accuracy of 3D ultrasonography in prenatal detection of urinary bladder wall involvement in abnormally invasive placenta (AIP) at 3rd trimester of pregnancy .
All patients will be subjected to the following:
1-Written informed consent after explaining the aim of the study, procedure and possible hazards.
2-History taking includes full obstetric history, medical and surgical history. 3-Relevant physical examination.
- In all cases, detailed transabdominal and transvaginal examinations of the placenta, uterus and pelvis will be performed within 48 hours before surgery will be done by ultrasound equipment type (GE Voluson E10).
- During the ultrasound examination the following criteria will be studied:
- Placental localization and determining placental extension : The placenta will be recorded as low lying when the edge is 0.5-2 cm from the internal os of the uterine cervix. When the placenta is <0.5 cm from the internal os or completely covering it, it will be defined as placenta previa (marginal or complete respectively).
- The criteria suggested by the European working group on Abnormally invasive placenta (EW-AIP)25 which include:
- Loss of clear zone in the myometrium under the placental bed.
- Myometrial thinning to less than 1 mm.
- Intra-placental lacunae which are large and irregular.
- Bladder wall interruption or loss.
- Placental bulge or focal exophytic mass extending beyond the serosa of the uterus.
- Color Doppler images: -- Uterovesical hypervascularity between placenta and posterior wall of the bladder.
- Bridging vessels across the myometrium and beyond uterine serosa.
- Sub-placental hypervascularity.
- Lacunae feeder vessels with high velocity.
- The results of 3D ultrasound will be compared with the results of histopathological examination of the retrieved specimens in cases of cesarean hysterectomy or partial myometrial resection or with the operative finding of spontaneous and complete placental separation at laparotomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant in 3rd trimester with abnormally invasive placenta | Other | Diagnostic Test: 3 dimensional ultrasound |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton pregnancies
- Previous cesarean deliveries
- Gestational age (GA)> or= 28 weeks
- Low lying placenta previa totally or partially covering the internal os with lateral +/- anterior wall extension diagnosed as placenta accreta spectrum (PAS) disorders by 3D ultrasound
Key exclusion criteria (3 listed)
- Patient's refusal to participate
- Multifetal pregnancies
- Gestational age< 28 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 dimensional ultrasoundDetect the accuracy of 3D ultrasonography in prenatal detection of bladder wall involvement in abnormally invasive placenta (AIP) at 3rd trimester of pregnancy . | Diagnostic test | Pregnant in 3rd trimester with abnormally invasive placenta |
Primary outcome
Accuracy of 3 dimensional ultrasound in detection of urinary bladder invasion in patients with abnormally invasive placenta
Time frame: 6 months
The sensitivity and specificity of three dimensional ultrasound in the diagnosis of bladder wall invasion in patients with abnormally invasive placenta
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Placenta Accreta
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
Placenta Accreta, Third Trimester
Not yet recruitingObservational study
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
Placenta Accreta Management
Recruiting
Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
Placenta Accreta Spectrum
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 dimensional ultrasound in people with Placenta Accreta, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 3 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of 3 dimensional ultrasound in detection of urinary bladder invasion in patients with abnormally invasive placenta (time frame: 6 months). 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 30 Aug 2023.