Evaluation of the Fetal MPI in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome.

August 16, 2018 updated by: Ali Mohamed AbdEl-Halim Ali Mehanna

Evaluation of the Fetal Myocardial Performance Index in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome

The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.

Study Overview

Status

Unknown

Conditions

Detailed Description

The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.

Study Hypothesis:

In women with non reassuring fetal cardiotocography, myocardial performance index may predict fetal distress accurately.

Study Question:

In pregnant women in the third trimester with abnormal cardiotocography, Does myocardial performance index predict fetal distress accurately?

Study Objectives:

This study aims to assess the accuracy of myocardial performance index in predicting fetal distress in pregnant women with non reassuring cardiotocography in third trimester.

Study Type

Observational

Enrollment (Anticipated)

148

Contacts and Locations

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

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

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women in 3rd trimester attending for CTG

Description

Inclusion Criteria:

  1. Women between 30-40 weeks gestational age.
  2. Women pregnant in singleton fetus.

Exclusion Criteria:

  1. Multiple pregnancies.
  2. Fetal congenital malformation.

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

Cohorts and Interventions

Group / Cohort
Abnormal CTG
This group includes pregnancies that showed abnormalities in CTG.
Normal CTG
This group includes pregnancies that showed no abnormalities in CTG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the Fetal Myocardial Performance Index.
Time Frame: 3rd Trimester CTG, immediately followed by Fetal Echocardiography at the same set
Evaluation of the Fetal Myocardial Performance Index in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome.
3rd Trimester CTG, immediately followed by Fetal Echocardiography at the same set

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal outcome observation
Time Frame: Immediately postnatal (first five minutes after delivery)
APGAR score at the first and fifth minute
Immediately postnatal (first five minutes after delivery)

Collaborators and Investigators

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

Sponsor

Ali Mohamed AbdEl-Halim Ali Mehanna

Investigators

  • Study Chair: Mohamed H Nasr El din, MD, Professor
  • Study Director: Amr MA El Helaly, MD, Assistant Professor
  • Study Director: Noha AA Sakna, MD, Lecturer

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)

October 10, 2018

Primary Completion (Anticipated)

March 10, 2019

Study Completion (Anticipated)

March 10, 2020

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • USCU 230

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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