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

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

Study Locations

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.

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

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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