Cardiac Diseases With Pregnancy in Benisuef Localities

• Sponsor: Beni-Suef University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03043937
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Duration (Months): 23
• Patients Per Site Per Month: 17.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Heart Disease Structural Disorder Abscess of Cardiac Septum	Other: registry

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 400 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Cardiac Diseases With Pregnancy in Benisuef Localities
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
cardiac patients WHO class 1,2	Other: registry
cardiac patients WHO class 3,4	Other: registry

Outcome Measures

Primary Outcome Measures

1. Fetomaternal and neonatal outcome [2 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Benisuef		Egypt

Sponsors and Collaborators

• Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Momen Zakaria Mohammed mohammed, assisstant lecturer, Beni-Suef University
• ClinicalTrials.gov Identifier: NCT03043937
• Other Study ID Numbers: 1200
• First Posted: Feb 6, 2017
• Last Update Posted: May 19, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Heart Diseases

Study Results

No Results Posted as of May 19, 2017