Placenta AccretaNCT03530475
Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler
A study testing ultrasound and doppler in people with Placenta Accreta, run by Kasr El Aini Hospital.
Trial summary
This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- ultrasound and doppler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 22 May 2018to 22 Aug 2018
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Maternal chronic medical disorder (diabetes mellitus or hypertension).
- Pregnancy induced disorders (pre-eclampsia or gestational diabetes).
- Associated fetal anomalies.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler in Cases of Placenta Accreta
This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed).
All of those patients are presenting during the period of may 2018 to july 2018 to Kasr-Al Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester.
All of them will be assorted according to certain inclusion and exclusion criterions as follow:
Read the detailed description
This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed).
Those patients are attending to Kasr-Al Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester.
Ultrasound and doppler will be done to all patients to diagnose placenta accreta . The diagnosis will be confirmed by intraoperative assessments and histopathological examination of the uterus after cesarean hysterectomy
- Conditions
- Placenta Accreta
- Being tested
- ultrasound and doppler
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound and dopplerDiagnostic test
- Ultrasound examination (2D gray scale and color doppler )
- Confirming the presence of placenta previa 2,To assess the possibility of concomitant placenta accreta (Sonographic findings that have been associated with placenta accreta (1) Loss of normal hypoechoic retroplacental zone (2) Multiple vascular lacunae (irregular vascular spaces) within placenta, (3) Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface, or crossing uterine serosa1 (4) Retroplacental myometrial thickness of 1 mm (5) Bladder wall interruption (6) Presence of placental bulge (7) Utero-vesical hypervascularity (8) presence of lacunae feeder vessels.
- Assessment of uterine artery Doppler in different cases of placenta previa.
. Documentation of the operative findings during cesarean section and/or cesarean hysterectomy procedures.
Histopathological examination of the hysterectomy specimens to assess the degree of myometrial invasion.
| Study group | Role | What they receive |
|---|---|---|
| placenta previa | Active comparator | cases diagnosed as placenta previa diagnosed by ultrasound and doppler Receives: Diagnostic Test: ultrasound and doppler |
| placenta accreta | Active comparator | placenta previa diagnosed as placenta accreta by ultrasound and doppler Receives: Diagnostic Test: ultrasound and doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of ultrasound and doppler in detecting placenta accreta
accuracy of uterine artery doppler in diagnosing placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
Measured: 3 moths
Secondary outcomes (1)
accuracy of ultrasound in detecting placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
- Loss of normal hypoechoic retroplacental zone
- Multiple vascular lacunae (irregular vascular spaces) within placenta
- Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface, or crossing uterine serosa1
- Retroplacental myometrial thickness of 1 mm
- Bladder wall interruption
- Presence of placental bulge
- Utero-vesical hypervascularity
3.Intraoperative complications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start22 May 2018 (estimated)
- Primary completion22 Aug 2018 (estimated)
- Study completion22 Aug 2018 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hala nabil, Cairo University
- Investigators
- Hala Nabil, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530475
- Sponsor's protocol ID
- 5000
- Status last verified
- May 2018
- First submitted
- 7 May 2018
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler in Cases of Placenta Accreta
- ClinicalTrials.gov ID
- NCT03530475
- Acronym / sponsor ID
- 5000
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 22 May 2018 (estimated)
- Primary completion
- 22 Aug 2018 (estimated)
- Study completion
- 22 Aug 2018 (estimated)
- First posted
- 21 May 2018 (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.
This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed).
All of those patients are presenting during the period of may 2018 to july 2018 to Kasr-Al Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester.
All of them will be assorted according to certain inclusion and exclusion criterions as follow:
Detailed description
This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed).
Those patients are attending to Kasr-Al Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester.
Ultrasound and doppler will be done to all patients to diagnose placenta accreta . The diagnosis will be confirmed by intraoperative assessments and histopathological examination of the uterus after cesarean hysterectomy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placenta previa | Active comparator | Diagnostic Test: ultrasound and dopplercases diagnosed as placenta previa diagnosed by ultrasound and doppler |
| placenta accreta | Active comparator | Diagnostic Test: ultrasound and dopplerplacenta previa diagnosed as placenta accreta by ultrasound and doppler |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Maternal chronic medical disorder (diabetes mellitus or hypertension).
- Pregnancy induced disorders (pre-eclampsia or gestational diabetes).
- Associated fetal anomalies.
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 |
|---|---|---|
| ultrasound and doppler• Ultrasound examination (2D gray scale and color doppler ) 1. Confirming the presence of placenta previa 2,To assess the possibility of concomitant placenta accreta (Sonographic findings that have been associated with placenta accreta (1) Loss of normal hypoechoic retroplacental zone (2) Multiple vascular lacunae (irregular vascular spaces) within placenta, (3) Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface, or crossing uterine serosa1 (4) Retroplacental myometrial thickness of 1 mm (5) Bladder wall interruption (6) Presence of placental bulge (7) Utero-vesical hypervascularity (8) presence of lacunae feeder vessels. 3. Assessment of uterine artery Doppler in different cases of placenta previa. . Documentation of the operative findings during cesarean section and/or cesarean hysterectomy procedures. Histopathological examination of the hysterectomy specimens to assess the degree of myometrial invasion. | Diagnostic test | placenta accreta, placenta previa |
Primary outcome
accuracy of ultrasound and doppler in detecting placenta accreta
Time frame: 3 moths
accuracy of uterine artery doppler in diagnosing placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
1 secondary outcome
accuracy of ultrasound in detecting placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Individual participant dataSharing planned: Undecided
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Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
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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.
Hala Nabil, M.D principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and doppler in people with Placenta Accreta, run by Kasr El Aini Hospital.
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 0 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: status not confirmed, as of the sponsor's last update on 25 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hala Nabil, M.D (02001002412549, fawzy.jana@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of ultrasound and doppler in detecting placenta accreta (time frame: 3 moths). 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 25 May 2018.