Evaluation of the Fetal MPI in Abnormal Cardiotocography... | NCT03638245

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

NCT03638245

Sponsor

Ali Mohamed AbdEl-Halim Ali Mehanna

Status

Unknown status

Last Update Posted

Aug 20, 2018Actual

Enrollment

148Estimated

Phase

Not provided

Conditions

Echocardiography

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2018Estimated

Primary Completion Date

Mar 10, 2019Estimated

Completion Date

Mar 10, 2020Estimated

First Submitted Date

Aug 13, 2018

First Submission Date that Met QC Criteria

Aug 16, 2018

First Posted Date

Aug 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2018

Last Update Posted Date

Aug 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ali Mohamed AbdEl-Halim Ali Mehanna, Dr, Ain Shams Maternity HospitalSponsor-Investigator

Lead Sponsor

Ali Mohamed AbdEl-Halim Ali MehannaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

148Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abnormal CTG		This group includes pregnancies that showed abnormalities in CTG.
Normal CTG		This group includes pregnancies that showed no abnormalities in CTG.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the Fetal Myocardial Performance Index.	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Multiple pregnancies.
Fetal congenital malformation.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pregnant women in 3rd trimester attending for CTG

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ali MA Mehanna, MSc.	Contact	+201116778899		alymehanna90@hotmail.com

Overall Officials

Name	Affiliation	Role
Mohamed H Nasr El din, MD	Professor	Study Chair
Amr MA El Helaly, MD	Assistant Professor	Study Director
Noha AA Sakna, MD

Locations

Not provided