NCT03095937

Brief Summary

The goal of this study is to evaluate fetal myocardial performance in patients with heart diseases in comparison to normal pregnant patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

March 20, 2017

Last Update Submit

February 15, 2020

Conditions

Fetal Distress

Outcome Measures

Primary Outcomes (1)

  • Myocardial performance index

    Percentage of isovolumetric time to ejection time

    30 minutes

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women with compensated rheumatic heart disease and pregnant women with normal pregnancy with the same inclusion/exclusion criteria listed below. Inclusion criteria: 1. Age of the patient: 15-40 years old. 2. Compensated rheumatic heart disease. 3. singleton Singleton pregnancy. 4. Normal placental location. Exclusion criteria: The patients have hypertension, diabetes or any other medical disorders affecting pregnancy.

You may qualify if:

  • Compensated heart disease.
  • singleton pregnancy
  • Normal placental location
  • Have no associated hypertension, diabetes or any other medical disorders affecting pregnancy

You may not qualify if:

  • The patients have hypertension, diabetes or any other medical disorders affecting pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 30, 2017

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

EG(1)