Back to resultsDoppler Imaging and Morbidly Adherent Placenta
Primary Purpose
Antepartum Hemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3D Doppler Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Antepartum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Age: 18 - 45.
- Pregnant 32 weeks or more.
- Placenta previa (Major and Minor).
- History of previous cesarean section.
Exclusion Criteria:
- Medical disorders such as bleeding disorders.
- Lethal fetal anomalies.
- Delivery before 34 weeks.
Sites / Locations
- Kasr el aini hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional group
Arm Description
Patients confirmed having one or more of the signs of morbidly adherent placenta will be examined by 3D Ultrasound and 3D power Doppler. Patients will then be prepared for the operation.Cesarean hysterectomy will be done with removal of the uterus and the placenta as one mass.Cases with focal invasion of the uterus will be given a trial for conservative management. The whole specimen will be sent for histopathological examination, and the determination of length and depth of invasion.
Outcomes
Primary Outcome Measures
Sensitivity of 3D power Doppler in detecting morbidly adherent placenta.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03267446
Brief Title
Doppler Imaging and Morbidly Adherent Placenta
Official Title
The Role of Grey Scale Ultrasound, 2D, and 3D Power Doppler in Diagnosing and Predicting the Surgical Risks in Patients With Morbidly Adherent Placenta.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta as well as predict the surgical outcome regarding the type of surgery and the intra operative morbidities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antepartum Hemorrhage
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Patients confirmed having one or more of the signs of morbidly adherent placenta will be examined by 3D Ultrasound and 3D power Doppler. Patients will then be prepared for the operation.Cesarean hysterectomy will be done with removal of the uterus and the placenta as one mass.Cases with focal invasion of the uterus will be given a trial for conservative management. The whole specimen will be sent for histopathological examination, and the determination of length and depth of invasion.
Intervention Type
Device
Intervention Name(s)
3D Doppler Ultrasound
Intervention Description
3D volumes will be obtained in automatic sweeps using a motorized curved-array transducer while the women held their breath. In order to interpret the data consistently, the settings of power, On Voluson E10; GE Medical Systems)
Primary Outcome Measure Information:
Title
Sensitivity of 3D power Doppler in detecting morbidly adherent placenta.
Time Frame
12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 18 - 45.
Pregnant 32 weeks or more.
Placenta previa (Major and Minor).
History of previous cesarean section.
Exclusion Criteria:
Medical disorders such as bleeding disorders.
Lethal fetal anomalies.
Delivery before 34 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Hussein, MD
Phone
01223 515652
Ext
002
Email
ahmed_mhussein@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dina M Dakhly, MD
Phone
01003498919
Ext
002
Email
dinadakhly@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Hussein, MD
Organizational Affiliation
Cairo Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr el aini hospital
City
Cairo
ZIP/Postal Code
12211
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Hussein, MD
Phone
01223515652
Ext
002
Email
ahmed_mhussein@live.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Doppler Imaging and Morbidly Adherent Placenta
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