Magnetic Resonance Imaging (MRI ) Versus Ultrasound in Placenta Accreta Diagnosis

July 16, 2020 updated by: Safaa thabet abd El Aziz Ahmed, Ain Shams University

Gray-scale , Colour Doppler Ultrasound and Magnetic Resonance Imaging for Diagnosis of Placenta Accreta

This study aim to assess the accuracy of magnetic resonance imaging (MRI) compared to gray-scale and colour Doppler ultrasound (US) for the prenatal diagnosis of placenta accreta.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Placenta accreta occurs when the chorionic villi abnormally invade the myometrium. Based on histopathology it is divided into three grades: placenta accreta (the chorionic villi are in contact with the myometrium), placenta increta (the chorionic villi invade the myometrium), and placenta percreta where the chorionic villi penetrate the uterine serosa. With increasing rate of cesarean delivery, the incidence of both placenta praevia and placenta accreta is steadily increasing in frequency.

Prenatal diagnosis of invasive placentation is associated with a reduced risk of maternal complications as it allows a preplanned treatment of the condition . Gray-scale and colour Doppler ultrasound (US) are valuable tools in the prenatal diagnosis of placenta accreta .However, if the ultrasound ( US ) findings suggest possible percreta or are inconclusive or negative in an at-risk woman, magnetic resonance imaging (MRI) can be useful.

Multiple sonographic findings are seen with placenta accreta such as decrease in myometrial thickness, placenta previa, placental lacunae, abnormal pattern of color Doppler, loss of the retroplacental clear zone and placenta percreta irregularities in wall of urinary bladder ( UB ) have been detected .

The most magnetic resonance imaging characteristic findings seen in placenta accreta are nodular thickening in the dark zone of placenta-uterine interface together with extensions of dark bands through the placenta, outer uterine bulge causing from the mass effect of the placenta and heterogeneous signal intensity of placenta on the T2-weighted HASTE sequences due to large placental lakes and vessels.

Study Type

Observational

Enrollment (Anticipated)

100

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 Contact Backup

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

18 years to 38 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Haemodynamically stable pregnant women, who attend the antenatal care clinic at Ain Shams University Hospital or are referred from other hospitals for further evaluation. The recruited patients have to fulfill the inclusion criteria,

Description

Inclusion Criteria:

  • Haemodynamically stable pregnant women who have the following risk factors for placenta accreta : persistent anterior placenta previa, prior uterine surgery (such as a previous cesarean section, uterine curettage, or myomectomy).
  • Maternal age : 20-40 years old.
  • BMI : 18-29.9 kg/m2.

Exclusion Criteria:

  • Exclusion criteria will be MRI contraindications, cardiac pacemaker, metal objects in the body, and patient's refusal for MRI evaluation.
  • Haemodynamically unstable patients.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of degree of placental invasion
Time Frame: Baseline
Determination of degree of placental invasion by comparing the results obtained by ultrasound , MRI with the final pathological examination after operation ( the excised part of myometrium with the attached placenta or hysterectomy specimen ).
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Change Maternal morbidity and mortality
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

November 17, 2018

First Submitted That Met QC Criteria

January 20, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRI placenta accreta

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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