NCT03043937

Brief Summary

The aim of this work is to demonstrate the variation of cardiac diseases among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

January 6, 2017

Last Update Submit

May 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fetomaternal and neonatal outcome

    Number of Participants With abortion,preterm labour,Intrauterine fetal death,Postterm fetus, intrauterine growth restriction,Fetuses with Congenital heart diseases,Neonatal admission to Neonatal Intensive care unit,neonatal death,Perineal,vaginal,broad ligament haematoma, Internal Hemorrhage due to anticoagulant drugs,malfunctioning valve,heart failure ,Thromboembolic complications, perinatal maternal death.

    2 years

Study Arms (2)

cardiac patients WHO class 1,2

Other: registry

cardiac patients WHO class 3,4

Other: registry

Interventions

cardiac patients WHO class 1,2cardiac patients WHO class 3,4

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A prospective analytical study is managed to be commenced in Beni-Suef governorate as cooperation between Department of Cardiology and Department of Obstetrics and Gynaecology Beni-Suef University during the period between Jan/2015 and Dec/2016 among women with cardiac diseases during pregnancy regardless gestational age at presentation and up till 6 weeks postpartum in comparison to women free from any cardiac diseases.

You may qualify if:

  • All pregnant ladies with Cardiac diseases, valvular heart disease, congenital heart disease, ischemic heart disease, cardiomyopathy, arrhythmias , big and pulmonary hypertension, presenting with pregnancy regardless age, any concomitant diseases and type of heart disease will be enrolled.
  • A similar number of pregnant females free from previous mentioned cardiac diseases will be studied as controls.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Benisuef, Egypt

Location

MeSH Terms

Interventions

Registries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

January 6, 2017

First Posted

February 6, 2017

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 19, 2017

Record last verified: 2017-05

Locations