Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings

December 7, 2022 updated by: Fatma Fathy Hafez Ismail, Cairo University
This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

21

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

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

28 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

21 pregnant females during their late 3rd trimester between (34 0/7: 37 0/7 weeks gestation)

Description

Inclusion Criteria:

  • Age group 28:42 years.
  • Pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks).
  • With a single living fetus in the current pregnancy.
  • A previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation)
  • Having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.

Exclusion Criteria:

  • Cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta.
  • Maternal chronic medical disorders( diabetes mellitus, hypertension)
  • Patients presented with severe attack of bleeding.
  • Patients presented with rupture of membrane.
  • Emergency delivery regardless the cause.

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: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical significance of ultrasound signs in morbidly adherent placenta(most sensitive US sign)
Time Frame: June 2021- July 2022
June 2021- July 2022
Accuracy of our specialized pro forma in assessing extent of morbidly adherent placenta(focal , diffuse)
Time Frame: June 2021- July 2022
June 2021- July 2022
Accuracy of our specialized pro forma in assessing depth of invasion of placenta accreta spectrum (accrete, increta and percreta)
Time Frame: June 2021- July 2022
June 2021- July 2022

Secondary Outcome Measures

Outcome Measure
Time Frame
1- Correlation between US signs and intraoperative findings including morbidity and mortality
Time Frame: June 2021- July 2022
June 2021- July 2022

Collaborators and Investigators

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

Sponsor

Cairo University

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)

June 18, 2021

Primary Completion (Anticipated)

January 30, 2023

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 23-2021

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.

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