- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06755047
3D Placental Volume in Placenta Accreta
December 31, 2024 updated by: Mohamed Gamal M.fekry, Assiut University
3D Ultrasound Placental Volume and Vascular Indices Versus 2D Parameters for Diagnosis of Placenta Accreta Spectrum
Placenta Accreta spectrum is a major obstetric disease nowadays.
Different methods are used for antenatal diagnosis.
In our study, investigators are aiming to compare 2 common ways for diagnosis, i.e; 3D Ultrasound and 2D with color Doppler.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The word placenta accreta spectrum disorders (PASD) implies an atypical implantation of the placenta into the uterine wall and has been used to express placenta accreta, increta and percreta.
Placenta accreta is a placenta where the placental villi sick on directly to the myometrium.
Placenta increta is a placenta where the placental villi attack into the myometrium and placenta percreta is a placenta where the villi invade through the myometrium and into serosa.
No antenatal diagnostic method gives the clinician 100% assurance of either ruling in or ruling out the existence of placenta accreta.
The definitive diagnosis of placental accreta spectrum is frequently ended postpartum on hysterectomy specimens when an area of accretion shows chorionic villi which make direct contact with the myometrium and absence of deciduae.
Antenatal ultrasound is the method of choice used to establish the diagnosis and direct clinical management.The combined use of power Doppler with three dimensional (3D) ultrasound provides the possibility of quantifying moving blood within a volume of interest.
Three indices are calculated, namely vascularization index (VI), flow index and vascularization flow index
Study Type
Observational
Enrollment (Estimated)
38
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: Mohamed Fekry, PhD
- Phone Number: 0882312
- Email: mohamedbeethoven2040@gmail.com
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- Women's health hospital
-
Contact:
- Mohamed Fekry, Lecturer
- Phone Number: 0882312388
- Email: mohamedbeethoven2040@gmail.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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
All patients with placenta previa from 24 -39 weeks will be counselled to participate in the study.
Patients will be enrolled in one of the 2 groups.
Group 1, 3D Ultrasound with placental volume and vascular indices will be calculated.
Group 2 , 2D ultrasound parameters and color Doppler study will be performed.
Description
Inclusion Criteria:
- pregnant women with placenta previa
Exclusion Criteria:
- congenital anomalies of placenta Placental separation Uterine anomalies
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
3D Ultrasound
3D ultrasound placental volume, vascularization index, flow index and VF index
|
3D placental volume and vascular indices
|
|
2D ultrasound
lacunar vascular flow, abnormal utero-placental interference, myometrial thinning (>1mm), absence of the retroplacental myometrium, interruptions or irregularities at the level of the utero-vesical interference, lower uterine segment hypervascularity
|
2D placental criteria of invasion and color Doppler
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vascular index
Time Frame: 1 months
|
3D Vascularization index
|
1 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2D ultrasound
Time Frame: 1 months
|
myometrial thinning (>1mm),
|
1 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 31, 2024
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
December 12, 2024
First Submitted That Met QC Criteria
December 31, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 31, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3D
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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