NCT00403871

Brief Summary

Heart disease among pregnant women is increasing in incidence. The cardiovascular changes associated with pregnancy may be particularly hazardous for both mother and fetus in a subset of these patients. The period of greatest risk is peripartum while these patients are under the care of the obstetrician and anesthesiologist. We will evaluate the anesthetic management of all women with heart disease whose pregnancies were followed at the University Health Network and/or Mount Sinai Hospital between 1986 and 2001.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2002

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

November 1, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
Last Updated

March 2, 2007

Status Verified

February 1, 2007

First QC Date

November 23, 2006

Last Update Submit

February 28, 2007

Conditions

Heart DiseasesPregnancy

Keywords

AnaesthesiaPregnencyHeart disease

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women with congenital or acquired heart disease
  • Pregnant women with arrhythmias are also included providing they had had symptomatic tachyarrhythmias or bradyarrhythmias requiring treatment

You may not qualify if:

  • Women with isolated mitral valve prolapse including those with mild to moderated mitral regurgitation
  • Women referred for termination of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Univeristy Health Network

Toronto, Ontario, M5G 1Z5, Canada

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Eric Goldszmidt, MD

    Mount Sinai Hosiptal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2006

First Posted

November 27, 2006

Study Start

November 1, 2002

Study Completion

June 1, 2005

Last Updated

March 2, 2007

Record last verified: 2007-02

Locations

CA(2)