FGR Diagnostic Criteria in Predicting Adverse Neonatal Outcomes

June 18, 2021 updated by: Radwa Rasheedy Ali, Ain Shams University

Accuracy of the Recent Consensus Based Definition of FGR Encompassing Biometric and Doppler Parameters in Predicting Adverse Neonatal Outcomes

The purpose of this study is to evaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW <10th percentile according to the Hadlock growth standard).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

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
        • Ain Shams University Maternity Hospital
        • Contact:
          • Ahmed Essam, MD

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

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

all pregnancies with FGR (EFW <10th percentile) who were admitted in Ain Shams University Maternity Hospital during the period from January 2016 till December 2020.

Description

Inclusion Criteria:

  • Participants included in this study will have the following criteria:

    • Pregnancies complicated with FGR (EFW <10th percentile).
    • Singleton pregnancy.

Exclusion Criteria:

  • • Fetal structural malformations or chromosomal abnormalities as detected by neonatal examination and anomaly scan during pregnancy.

    • Identified infectious etiologies detected during immediate postnatal examination or during pregnancy.
    • Gestational age cannot be calculated accurately.
    • Missing antenatal or perinatal outcome data.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 30 days after delivery
neonatal outcome
30 days after delivery

Collaborators and Investigators

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

Sponsor

Ain Shams 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 (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Asu FM

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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