Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum

March 13, 2021 updated by: Ahmad Sayed Reyad, Assiut University

Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum: A Prospective Cohort Study

To evaluate the association of ultrasonographic parameters suggestive of placenta accreta with intraoperative clinical diagnosis of placenta accreta according to the the clinical grading system for placenta accreta spectrum (PAS) disorders proposed recently by FIGO and histopathological diagnosis of placenta accreta in hysterectomy specimens

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Evaluation of the association of ultrasonographic parameters suggestive of placenta accreta with intraoperative clinical diagnosis of placenta accreta according to the the clinical grading system for placenta accreta spectrum (PAS) disorders proposed recently by FIGO and histopathological diagnosis of placenta accreta in hysterectomy specimens The following ultrasound items will be examined: number and viability of fetuses, amniotic fluid assessment, fetal biometries, fetal gender if possible, fetal presentation, Estimated fetal weight using Hadlock formula, Umbilical Artery Pulsatility Index (UA PI) measured from an automated/manual trace of at least three consecutive waveforms of the relevant vessel in the absence of fetal breathing movements or uterine contractions. The UA PI will be recorded from a free-floating section of cord.

Next step the investigators will look for suggestive ultrasound parameters of placenta accreta including:

  1. Location of placenta: Placenta previa anterior / posterior / totally covering the internal cervical os.
  2. Lacunae staging according to Finberg and Williams as follows: grade 0, none seen; grade 1, 1-3 present and generally small; grade 2, 4-6 present and tending to be larger and more irregular; grade 3, many throughout the placenta and appearing large and bizarre.
  3. Loss of the clear zone, defined as loss or irregularity of the hypoechoic plane in the myometrium underneath the placental bed
  4. Bladder wall interruption, defined as loss or interruption of the bright bladder wall (hyperechoic band or 'line' between the uterine serosa and bladder lumen)
  5. Uterovescical hypervascularity, defined as a striking amount of color Doppler signal seen between the myometrium and the posterior wall of the bladder, including vessels appearing to extend from the placenta, across the myometrium and beyond the serosa, into the bladder or other organs, often running perpendicular to the myometrium.
  6. Increased vascularity in the parametrial region, defined as the presence of hypervascularity extending beyond the lateral uterine walls and involving the region of the parametria .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All females in age range between 18 years old and 45 years old who are diagnosed as placenta accreta spectrum disorder in antenatal care at Assiut University, Women Health Hospital at time between May 2021 and May 2023 will be included in the study

Description

Inclusion Criteria:

All patients diagnosed with placenta previa previa or low lying placenta during pregnancy at any gestational age will be included and followed up until termination of pregnancy. The diagnosis of placenta previa was based on the presence of placental tissue overing the internal cervical os and Low-lying placenta was diagnosed when the placenta was within 2 cm from the internal cervical os but did not cover it

Exclusion Criteria:

  • Impaired liver or renal functions.
  • Coagulation disorders.
  • Associated uterine pathology needing hysterectomy.
  • Patient's refusal to participate in clinical research.
  • Multiple pregnancy

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the association of ultrasonographic parameters with the intraoperative FIGO clinical grading for diagnosis of placenta accreta spectrum disorder and histopathological diagnosis of placenta accreta in hysterectomy specimens
Time Frame: Bseline
Grade 1 : Complete placental separation at third stage, Grade 2 : removal of placenta required and parts of placenta thought to be abnormally adherent, Grade 3 : Manual removal of placenta required and the whole placental bed thought to be abnormally adherent, Grade 4 : Placental tissue seen to have invaded through the serosa of the uterus but a clear surgical plane can be identified between the bladder and uterus, Grade 5 : Placental tissue seen to have invaded through the serosa of the uterus and a clear surgical plane cannot be identified between the bladder and uterus, Grade 6 : Placental tissue seen to have invaded through the serosa of the uterus and infiltrating the parametrium or any organ other than the urinary bladder
Bseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association of each ultrasonographic parameter of placental invasion with maternal and fetal complications
Time Frame: Baseline
  1. Maternal complications both intra and post-operatively including cesarean hysterectomy, ICU admission, bladder injury, bowel injury and death.
  2. Fetal and neonatal complications including Apgar score less than 7 at 5 min, RDS, NICU, preterm and neonatal death.
  3. Development of ultrasound scoring system for prediction of placenta accreta.
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut 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.

Helpful Links

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Prenatal US and clinical FIGO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Placenta Accreta, Unspecified Trimester

Clinical Trials on Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings