- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03286998
Ultrasound in Prediction of Operative Findings in Cesarean Section Among Placenta Accreta Cases
December 16, 2020 updated by: Moutaz Sherbini, Cairo University
The Efficacy of Ultrasound in Predicting Operative Findings and Co-morbidities in Cesarean Section Among Cases of Placenta Accreta
A total of 60 women pregnant more than 28 weeks gestation will be recruited from obstetric outpatient clinic (faculty of medicine -Cairo University Hospital) after being diagnosed of having placenta previa or low lying placenta by grey scale ultrasound.
Placenta will be reexamined by grey scale ultrasound & color Doppler.
Sonographic parameters evaluated will include placental location, loss of retro-placental clear zone, irregularity and thickness of the uterine-placental interface, the smallest myometrial thickness in sagittal and transverse planes, presence of lacunar spaces and bridging vessels & the presence of abnormal vasculature.
The sonographic findings will be compared with intraoperative ones.
Hysterectomy specimen (if any was done) will be evaluated histo-pathologically to assess the degree of placental invasion & to confirm the accreta status.
The aim of the study is to determine the efficacy of ultrasound in predicting operative findings and associated co-morbidties among cases of placenta accreta.
Study Overview
Status
Unknown
Conditions
Detailed Description
60 pregnant women with singleton living healthy fetus diagnosed as having placenta previa by grey scale ultrasound and candidate for repeated elective cesarean section (CS) or elective cesarean hysterectomy (if the diagnosis of placenta accreta is confirmed) will be included in the study.
Inclusion criteria include: maternal age between 20 & 40 years old, gestational age more than 28 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan), one or more cesarean section scar & the presence of placenta previa with high possibility of being placenta accreta when scanned by grey scale ultrasound.
Women who had chronic or pregnancy induced diseases or any emergency or unplanned CS will be excluded.
Informed consents will be obtained from all patients after explanation of the aim of the study & the potential risks.
For all patients, full history will be taken followed by complete physical examination & routine obstetric ultrasound (to confirm the presence of placenta previa i.e. placental tissue covers the internal cervical os or within 2 cm from it).
For all Participants, the placentae will be reexamined in systematic manner by gray-scale & color Doppler ultrasound via transabdominal and/or transvaginal approach using Volusion Pro-V ultrasonography machine (GE Healthcare Austria GmbH, Seoul, Korea).
All exams will be done by expert sonographer & the possibility of concomitant placenta accreta will be checked.
The placenta will be scanned with adequate bladder volume to visualize the bladder- uterine serosal interface correctly & the angle of insonation will kept as low as possible.
The presence of one or more of the following features in grey scale ultrasound will be indicative of placenta accreta (presence of abnormal placental lacunae / complete loss of retroplacental sonolucent zone / myometrial thinning / disruption of the uterine serosa-bladder interface / presence of mass invading the urinary bladder).
Similarly, placenta accreta will be diagnosed by the presence of at least one of the following features in color Doppler scan: diffuse or focal lacunar flow - sonolucent vascular lakes - hypervascularity of the utero-vesical interface with bridging vessels connecting the placenta to the bladder).
The sonographic provisional diagnosis (i.e placenta previa, focal accreta, accreta , increta or percreta) with the concomitant invasion of adjacent structures (e.g., the urinary bladder) will be documented.
For all participants, termination of pregnancy will be by elective CS or elective cesarean hysterectomy.
Furthermore, operative findings as regard the placenta and the invasion of adjacent structures will be documented.
All operative procedures will be done by senior staff obstetrician with special interest in placenta accreta.
For hysterectomy specimens, histopathological examination will be done to assess the degree of myometrial invasion & to confirm the diagnosis of placenta accreta.
Maternal morbidities (i.e.
massive bleeding with the need of blood transfusion, pelvic organ injury or ICU admission) or mortalities will be documented.
Neonatal morbidities (i.e.
prematurity or NICU admission) or mortalities will be documented.
The ultrasonographic findings will be compared to operative details and histopathological reports.
The aim of the study is to evaluate the efficacy of ultrasound in predicting operative findings and associated co-morbidities among cases of placenta accreta.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: moutaz elsherbini, M.D.
- Phone Number: (+2)01001588300
- Email: mizosherbini@yahoo.com
Study Contact Backup
- Name: Marwa Eid, M.D
- Phone Number: (+2)01001225079
- Email: marwaeid2014@gmail.com
Study Locations
-
-
-
Cairo, Egypt, 115431
- Not yet recruiting
- Kasr Elainy Hospital (Cairo University)
-
Contact:
- moutaz elsherbini, M.D.
- Phone Number: (+2)01001588300
- Email: mizosherbini@yahoo.com
-
Cairo, Egypt
- Recruiting
- Faculty of Medicine- Cairo University
-
Contact:
- Moutaz Sherbini, MD
- Phone Number: 01001588300
- Email: mizosherbini@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
A total of 60 women pregnant more than 28 weeks gestation will be recruited from obstetric outpatient clinic (faculty of medicine -Cairo University Hospital) after being diagnosed of having placenta previa or low lying placenta by grey scale ultrasound.
Description
Inclusion Criteria:
- Maternal age between 20 & 40 years old
- Singleton living healthy fetus.
- Having placenta previa by grey scale ultrasound with high possibility of being placenta accreta when scanned by grey scale ultrasound
- Gestational age more than 28 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan).
- One or more cesarean section scar
Exclusion Criteria:
- Women who had chronic or pregnancy induced diseases
- Emergency or unplanned CS will be performed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
placenta previa
pregnant women with singleton living healthy fetus diagnosed as having placenta previa by grey scale ultrasound (placental tissue covers the internal cervical os or within 2 cm from it)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the accuracy of ultrasound in predicting operative finding in cases of placenta accreta
Time Frame: during cesarean section or elective cesarean hysterectomy
|
compare ultrasound report findings with the operative details report in hospital records
|
during cesarean section or elective cesarean hysterectomy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Moutaz Elsherbini, M.D, Assistant professor of obstetrics and gynecology - Cairo university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2017
Primary Completion (Anticipated)
January 1, 2021
Study Completion (Anticipated)
February 1, 2021
Study Registration Dates
First Submitted
September 15, 2017
First Submitted That Met QC Criteria
September 15, 2017
First Posted (Actual)
September 19, 2017
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 16, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110149
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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