Placenta AccretaNCT03437291
Comparison Between the Role of Transabdominal Ultrasound Versus Transvaginal Ultrasound in Evaluation of Placental Invasion in Cases of Placenta Previa Anterior Wall With Previous Uterine Scar
An observational study of Placenta Accreta, run by Cairo University at 1 site in Egypt.
Trial summary
Objective: To compare between the role of Transabdominal ultrasound versus Transvaginal ultrasound in evaluation of placental invasion in cases of placenta previa anterior wall with previous uterine scar applying the unified ultrasonographic descriptors suggested by the European working group on abnormally invasive… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Cesarean section, Transabdominal ultrasound and Transvaginal ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Mar 2018
- Phase
- Observational
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women in the reproductive age group (18 - 45) diagnosed persistent placenta previa anterior wall after 28 weeks of gestation , with history of previous Caesarian Section and/or any other type of uterine surgeries
Who may be able to join
- Pregnant women in the reproductive age group (18 - 45) diagnosed persistent placenta previa anterior wall after 28 weeks of gestation , with history of previous Caesarian Section and/or any other type of uterine surgeries
Who cannot join
- Placenta previa posterior wall
- unscarred uterus
Trial locations and contacts
1 site in 1 country.
Sherif Dahab, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12111
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Objective:
To compare between the role of Transabdominal ultrasound versus Transvaginal ultrasound in evaluation of placental invasion in cases of placenta previa anterior wall with previous uterine scar applying the unified ultrasonographic descriptors suggested by the European working group on abnormally invasive placenta "EW-AIP' Also to evaluate the sensitivity and specificity of each criterion by comparing them with the final outcome of pregnancy Fifty pregnant women with persistent placenta previa (after 28 weeks' gestation) were prospectively enrolled into this study. Both transabdominal and transvaginal ultrasound were performed by two different operators who were blinded to the results of each other.
Read more
the placenta was studied as regarding the exact loacalization and the unified descriptors were applied and evaluated by TAS and TVS.
The ultrasound findings were analyzed with reference to the final diagnosis made during Cesarean delivery and histopathological examination
Read the detailed description
Definitive diagnosis of Abnormally Invasive Placenta was made at delivery when the myometrium was seen to be invaded by the placenta, and the pathological examination of the removed uterus showed the villi attached to the myometrium without intervening decidua (accreta), invading into the myometrium (increta) or reaching the serosa (percreta).
-Complete imaging using all diagnostic techniques (gray-scale, color Doppler) by both transabdominal and transvaginal by two expert operators, then an offline analysis of the acquired images \& volumes was done Ultrasound examination was performed using a 2D ultrasound system equipped with a 4-8-MHz trans-abdominal transducer and a 12 MHz transvaginal transducer The transvaginal ultrasound was performed by a highly experienced operator whereas the transabdominal ultrasound was performed by a less experienced one and both were blinded from the results of each other Placenta was examined while the bladder was partially full about 300 ml for adequate visualization and precise localization
The Examined placenta is considered to be suspicious of abnormal invasion in case of having one or more of the unified descriptors described by the European working Group on Abnormally Invasive Placenta "EW-AIP":
- Conditions
- Placenta Accreta
- Being tested
- Cesarean section, Transabdominal ultrasound, Transvaginal 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.
Cesarean sectionProcedure or surgery
Also called lower segment cesarean section
Lower segment CS with evaluation of Placental site, spontaneous separation, placental invasion into the bladder and other surrounding organs, Uterotonic administration, Bladder , ureteric or bowel injury, blood loss and blood transfusion
Transabdominal ultrasoundDevice
Also called 2D ultrasound system equipped with a 4-8-MHz trans-abdominal transducer
loss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass
Transvaginal ultrasoundDevice
Also called 2D ultrasound system equipped with a 12 MHz transvaginal transducer
loss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass
| Study group | Role | What they receive |
|---|---|---|
| Abnormal placental invasion | patients had placenta previa with histopathologically confirmed abnormal invasion with all three grades i.e. accreta, increta and percreta, Receives: Procedure: Cesarean section; Device: Transabdominal ultrasound; Device: Transvaginal ultrasound | |
| Normal placenta | patients had placenta previa with no abnormal invasion Receives: Procedure: Cesarean section; Device: Transabdominal ultrasound; Device: Transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
abnormal placental invasion
detection of abnormally invsive placenta at histopathological examination
Measured: At time of cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study startMar 2016
- Primary completionFeb 2018 (estimated)
- Study completionMar 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437291
- Sponsor's protocol ID
- 27
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2018
- Last updated
- 19 Feb 2018
- 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 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Role of Transabdominal Ultrasound Versus Transvaginal Ultrasound in Evaluation of Placental Invasion in Cases of Placenta Previa Anterior Wall With Previous Uterine Scar
- ClinicalTrials.gov ID
- NCT03437291
- Acronym / sponsor ID
- 27
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 19 Feb 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.
Objective:
To compare between the role of Transabdominal ultrasound versus Transvaginal ultrasound in evaluation of placental invasion in cases of placenta previa anterior wall with previous uterine scar applying the unified ultrasonographic descriptors suggested by the European working group on abnormally invasive placenta "EW-AIP' Also to evaluate the sensitivity and specificity of each criterion by comparing them with the final outcome of pregnancy Fifty pregnant women with persistent placenta previa (after 28 weeks' gestation) were prospectively enrolled into this study. Both transabdominal and transvaginal ultrasound were performed by two different operators who were blinded to the results of each other.
the placenta was studied as regarding the exact loacalization and the unified descriptors were applied and evaluated by TAS and TVS.
The ultrasound findings were analyzed with reference to the final diagnosis made during Cesarean delivery and histopathological examination
Detailed description
Definitive diagnosis of Abnormally Invasive Placenta was made at delivery when the myometrium was seen to be invaded by the placenta, and the pathological examination of the removed uterus showed the villi attached to the myometrium without intervening decidua (accreta), invading into the myometrium (increta) or reaching the serosa (percreta).
-Complete imaging using all diagnostic techniques (gray-scale, color Doppler) by both transabdominal and transvaginal by two expert operators, then an offline analysis of the acquired images \& volumes was done Ultrasound examination was performed using a 2D ultrasound system equipped with a 4-8-MHz trans-abdominal transducer and a 12 MHz transvaginal transducer The transvaginal ultrasound was performed by a highly experienced operator whereas the transabdominal ultrasound was performed by a less experienced one and both were blinded from the results of each other Placenta was examined while the bladder was partially full about 300 ml for adequate visualization and precise localization
The Examined placenta is considered to be suspicious of abnormal invasion in case of having one or more of the unified descriptors described by the European working Group on Abnormally Invasive Placenta "EW-AIP":
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abnormal placental invasion | – | Procedure: Cesarean section, Device: Transabdominal ultrasound, Device: Transvaginal ultrasoundpatients had placenta previa with histopathologically confirmed abnormal invasion with all three grades i.e. accreta, increta and percreta, |
| Normal placenta | – | Procedure: Cesarean section, Device: Transabdominal ultrasound, Device: Transvaginal ultrasoundpatients had placenta previa with no abnormal invasion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women in the reproductive age group (18 - 45) diagnosed persistent placenta previa anterior wall after 28 weeks of gestation , with history of previous Caesarian Section and/or any other type of uterine surgeries
Key inclusion criteria (1 listed)
- Pregnant women in the reproductive age group (18 - 45) diagnosed persistent placenta previa anterior wall after 28 weeks of gestation , with history of previous Caesarian Section and/or any other type of uterine surgeries
Key exclusion criteria (2 listed)
- Placenta previa posterior wall
- unscarred uterus
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 |
|---|---|---|
| Cesarean sectionAlso: lower segment cesarean sectionLower segment CS with evaluation of Placental site, spontaneous separation, placental invasion into the bladder and other surrounding organs, Uterotonic administration, Bladder , ureteric or bowel injury, blood loss and blood transfusion | Procedure or surgery | Abnormal placental invasion, Normal placenta |
| Transabdominal ultrasoundAlso: 2D ultrasound system equipped with a 4-8-MHz trans-abdominal transducerloss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass | Device | Abnormal placental invasion, Normal placenta |
| Transvaginal ultrasoundAlso: 2D ultrasound system equipped with a 12 MHz transvaginal transducerloss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass | Device | Abnormal placental invasion, Normal placenta |
Primary outcome
abnormal placental invasion
Time frame: At time of cesarean section
detection of abnormally invsive placenta at histopathological examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Sherif Dahab, MD contact
Ahmed Maged, MD principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 2 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 19 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (+2001005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abnormal placental invasion (time frame: At time of cesarean section). 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 19 Feb 2018.