Ultrasound Staging in the Placenta Accreta

January 31, 2020 updated by: Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

Efficacy of Ultrasound Staging System in Prediction of Morbidly Adherent Placenta

The investigators evaluated the efficacy of a staging system introduced by the American Institute of ultrasound in medicine 2015 including sonographic parameters associated with morbidly adherent placenta for antenatal prediction of placental invasion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Morbidly adherent placenta (MAP) defines a spectrum of conditions, including placenta accreta, increta, and percreta, which are associated with significant maternal and fetal morbidity and mortality. Ultrasound evaluation, with grayscale, is the recommended first-line modality for diagnosing MAP. Grayscale ultrasound features suggestive of placenta accreta include the loss of myometrial interface or retroplacental clear space, reduced myometrial thickness and the presence of intraplacental lacunae. Using a staging system by antenatal ultrasound can predict placental invasion antenatally.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11211
        • Beni-Suef University

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Prior lower segment cesarean section
  • Low lying anterior placenta
  • Singleton pregnancy

Exclusion Criteria:

  • Medical disorders
  • vasa previa

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Morbidly adherent placenta
This arm was given stage according to ultrasound features.
Device: Ultrasound
Pregnant women in 3rd trimester with anterior placenta previa and lower cesarean section scar. Ultrasound was done and according to parameters of the morbidly adherent placenta, a staging system was conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmation of the stage of myometrial placental invasion
Time Frame: 1 hour
By ultrasound, placental invasion in myometrium was given a stage
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: 1 hour
Documentation of complications intraoperative
1 hour

Collaborators and Investigators

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

Sponsor

Beni-Suef 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)

March 14, 2017

Primary Completion (Actual)

July 20, 2019

Study Completion (Actual)

December 25, 2019

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beni-Suef 3-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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