NCT03638245

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

August 13, 2018

Last Update Submit

August 16, 2018

Conditions

Echocardiography

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Neonatal outcome observation

    Immediately postnatal (first five minutes after delivery)

Study Arms (2)

Abnormal CTG

This group includes pregnancies that showed abnormalities in CTG.

Normal CTG

This group includes pregnancies that showed no abnormalities in CTG.

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women in 3rd trimester attending for CTG

You may qualify if:

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

You may not qualify if:

  • Multiple pregnancies.
  • Fetal congenital malformation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mohamed H Nasr El din, MD

    Professor

    STUDY CHAIR

  • Amr MA El Helaly, MD

    Assistant Professor

    STUDY DIRECTOR

  • Noha AA Sakna, MD

    Lecturer

    STUDY DIRECTOR

Central Study Contacts

Ali MA Mehanna, MSc.

CONTACT

+201116778899alymehanna90@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 20, 2018

Study Start

October 10, 2018

Primary Completion

March 10, 2019

Study Completion

March 10, 2020

Last Updated

August 20, 2018

Record last verified: 2018-08