Cardiac Diseases With Pregnancy in Benisuef Localities | NCT03043937

Studies
Cardiac Diseases With Pregnancy in Benisuef Localities

NCT03043937

Sponsor

Beni-Suef University

Status

Completed

Last Update Posted

May 19, 2017Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Heart Disease Structural Disorder Abscess of Cardiac Septum

Interventions

registry

Countries

Egypt

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

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jan 6, 2017

First Submission Date that Met QC Criteria

Feb 2, 2017

First Posted Date

Feb 6, 2017Estimated

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

May 18, 2017

Last Update Posted Date

May 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cardiac patients WHO class 1,2			Other: registry
cardiac patients WHO class 3,4			Other: registry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
registry	Other		cardiac patients WHO class 1,2 cardiac patients WHO class 3,4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

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.

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Benisuef			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D012042	Registries

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D011996	Records

Browse Leaves

Not provided

Browse Branches

Not provided