- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07250412
The Accuracy Of 3D Color Ultrasonography for Detecting the Degree of Placenta Accreta Spectrum Invasion
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Sohag, Egypt
- Faculty of medecine Sohag university
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Pregnant women with clinical or ultrasound suspicion of PAS, including:
- Placenta previa or low-lying placenta
History of previous cesarean section(s) or uterine surgery (e.g., myomectomy, D&C) 2. Gestational age ≥ 28 weeks at the time of ultrasound evaluation 3. Undergoing planned cesarean delivery in the study hospital 4. Availability of preoperative ultrasound imaging performed using a standardized protocol.
5. Patient can provide informed Written consent and Agree to participate in the study
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Exclusion Criteria: Patients with incomplete or poor-quality ultrasound data 2. Unavailability of intraoperative confirmation of placental invasion 3. Patients with placental abruption or other causes of acute bleeding requiring emergency delivery without imaging 4. Loss to follow-up prior to delivery 5. Declined consent or withdrew participation from the study
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ultrasonography
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Cesarian section for detection the degree of placenta Accreta spectrum invasion comparaple to 3D color Doppler
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation between preoperative ultrasound findings and the confirmed degree of Placenta Accreta Spectrum (PAS) severity (classified as accreta, increta, or percreta). o The classification will be based on intraoperative surgical findings.
Time Frame: Patient preg 28 wks compare finding intraoperative
|
Patient preg 28 wks compare finding intraoperative
|
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Correlation between preoperative ultrasound findings and the confirmed degree of Placenta Accreta Spectrum (PAS) severity (classified as accreta, increta, or percreta). o The classification will be based on intraoperative surgical findings.
Time Frame: Pt preg for more than 28wks preg and compare finding intraoperative
|
Pt preg for more than 28wks preg and compare finding intraoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-med-25-8____12MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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