Anaesthetic Management of Women With Heart Disease For Labor and Delivery

Tracking Information
First Submitted Date	November 23, 2006
First Posted Date	November 27, 2006
Last Update Posted Date	March 2, 2007
Study Start Date	November 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00403871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Anaesthetic Management of Women With Heart Disease For Labor and Delivery
Official Title	Anaesthetic Management of Women With Heart Disease For Labor and Delivery
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.
Detailed Description	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. Exposing a compromised patient to general anesthesia is further complicated by the cardiovascular stress response to intubation and surgery, the cardiorespiratory implications of mechanical ventilation, the cardiac depression and vasodilation from general anesthetics, residual post-operative respiratory depression from general anesthetics and narcotics and the stress of weaning from mechanical ventilation and post-operative pain. In the Adult Congenital Heart Program, obstetric patients are followed the by a specialized team of cardiologists, obstetricians and anesthesiologists who also follow all pregnant women referred with acquired cardiac disease. From this referral practice approximately 100 patients per year are now followed during their pregnancy and delivery. In conjunction with the ongoing system we intend to identify all parturients who delivered at the University Health Network (Toronto General Hospital) or Mount Sinai Hospital between the years 1986 and 2001. 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.
Study Type	Observational
Study Design	Observational Model: Defined Population; Primary Purpose: Screening; Time Perspective: Longitudinal; Time Perspective: Retrospective/Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Heart Diseases; Pregnancy
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Enrollment; (submitted: November 23, 2006)	700
Original Enrollment	Same as current
Study Completion Date	June 2005
Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: 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 Exclusion Criteria: Women with isolated mitral valve prolapse including those with mild to moderated mitral regurgitation; Women referred for termination of pregnancy
Sex/Gender	Sexes Eligible for Study: Female
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Canada
Removed Location Countries
Administrative Information
NCT Number	NCT00403871
Other Study ID Numbers	06-05; 02-0211-E
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborators	Not Provided
Investigators	Principal Investigator: Eric Goldszmidt, MD Mount Sinai Hosiptal
PRS Account	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Verification Date	February 2007